Atrial Fibrillation
Conditions
Brief summary
This study will evaluate the application of hAM at the time of cardiac surgery to decrease inflammation and the subsequent substrate to reduce incidence of post-operative atrial fibrillation. Patients will randomized 1:1 to receive either hAM application or standard of care.
Interventions
BIOLOGICALHuman Amniotic Membrane
Epicardial application of human amniotic membrane during cardiac surgery
Sponsors
University of Utah
National Center for Advancing Translational Sciences (NCATS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing primary elective CABG at the University of Utah Hospital * Ability to provided informed consent and follow-up with protocol procedures
Exclusion criteria
* Patients in AF at the time of surgery * Prior history of sternotomy * Prior history of pericarditis * Currently on aggressive antiarrhythmic therapy (does not include beta blockers) * Patients with an implantable cardiac device (pacemaker, ICD, CRT-D) * Ejection fraction \<45%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 1 month | The AM applied epicardially will be assessed for signs of hyperacute rejection i.e. membrane changing color; cardiac tamponade or constriction assessed by echocardiogram and transmission of infectious diseases. The incidence of adverse events (AEs) will be reported as percentages, with two-sided 95% confidence intervals. Statistical comparisons of AEs between the AM treatment and the control group will be made using a chi-square, or Fisher's exact test, as appropriate (based on the minimum expected cell frequencies). |
| Number of Participants With Post Op Atrial Fibrillation Between Patients Who Receive hAM and Controls | 1 month | The number of patients with Post Op Atrial Fibrillation will be compared between the treatment and control group using mobile telemetry. This comparison will be analyzed using chi-square or Fisher's exact test as appropriate. |
| proBNP (Serum) Between Groups at Time of Surgery | Surgery | Comparison of serum levels of proBNP between groups at the time of surgery (baseline). |
| C-reactive Protein (Serum) Between Groups at Time of Surgery | Surgery | Comparison of serum levels of CRP between groups at the time of surgery (baseline). |
| Interleukin-6 (Serum) Between Groups at Time of Surgery | Surgery | Comparison of serum measurement of IL-6 between groups at the time of surgery (baseline). |
| Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at Time of Surgery | Surgery | Comparison of serum levels of TNFa between groups at the time of surgery (baseline). |
| proBNP (Serum) Between Groups at 24 Hours Post-op | 24 hours | Comparison of serum proBNP levels between groups at 24 hours post-op |
| C-reactive Protein (Serum) Between Groups at 24-hours Post-op | 24 hours | Comparison of serum measurements of CRP between groups at 24 hours post-op |
| Interleukin-6 (Serum) Between Groups at 24-hours Post-op | 24 hours | Comparison of IL-6 serum levels between groups at 24 hours post-op |
| Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at 24 Hours Post-op | 24 hours | Comparison of serum levels of TNFa between groups at 24 hours post-op |
| proBNP (Serum) Between Groups at 48 Hours Post-op | 48 hours | Comparison of serum levels of proBNP between groups at 48 hours post-op |
| C-reactive Protein (Serum) Between Groups at 48 Hours Post-op | 48 hours | Comparison of serum CRP levels between groups at 48 hours post-op |
| Interleukin-6 (Serum) Between Groups at 48 Hours Post-op | 48 hours | Comparison of IL-6 serum results between groups at 48 hours post-op |
| Tumor Necrosis Factor - Alpha (Serum) Between Groups at 48 Hours Post-op | 48 hours | Comparison of serum TNFa levels between groups at 48 hours post-op |
| proBNP (Serum) Between Groups at 72 Hours Post-op | 72 hours | Comparison of serum levels of proBNP between groups at 72 hour post-op |
| CRP (Serum) Between Groups at 72 Hours Post-op | 72 hours | Comparison of serum levels of CRP between groups at 72 hour post-op |
| Interleukin-6 (Serum) Between Groups at 72 Hours Post-op | 72 hours | Comparison of IL-6 serum levels between groups at 72 hours post-op |
| TNFa (Serum) Between Groups at 72 Hours Post-op | 72 hours | Comparison of TNFa serum levels between groups at 72 hours post-op |
| proBNP (Serum) Between Groups at Follow-up | 1 month | Comparison of serum levels of proBNP between groups at follow-up |
| CRP (Serum) Between Groups at Follow-Up | 1 month | Comparison of serum CRP levels between groups at follow-up |
| Interleukin-6 (Serum) Between Groups at Follow-up | 1 month | Comparison of IL-6 serum levels between groups at follow-up |
| TNFa (Serum) Between Groups at Follow-up | 1 month | Comparison of TNFa serum levels between groups at follow-up |
| proBNP (Pericardial Fluid) Between Groups at Time of Surgery | Surgery | Comparison of proBNP levels in pericardial fluid between groups at time of surgery (baseline) |
| C-reactive Protein (Pericardial Fluid) Between Groups at Time of Surgery | Surgery | Comparison of CRP levels in pericardial fluid between groups at the time of surgery (baseline). |
| Interleukin-6 (Pericardial Fluid) Between Groups at Time of Surgery | Surgery | Comparison of IL-6 levels in pericardial fluid between groups at the time of surgery (baseline). |
| Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at Time of Surgery | Surgery | Comparison of TNFa in pericardial fluid between groups at the time of surgery (baseline). |
| proBNP (Pericardial Fluid) Between Groups at 24 Hours Post-op | 24 hours | Comparison of levels of proBNP in pericardial fluid between groups at 24 hours post-op |
| C-reactive Protein (Pericardial Fluid) Between Groups at 24 Hours Post-op | 24 hours | Comparison of CRP levels in pericardial fluid between groups at 24 hours post-op |
| Interleukin-6 (Pericardial Fluid) Between Groups at 24 Hours Post-op | 24 hours | Comparison of IL-6 levels in pericardial fluid between groups at 24 hours post-op |
| Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 24 Hours Post-op | 24 hours | Comparison of TNFa in pericardial fluid between groups at 24 hours post-op. |
| proBNP (Pericardial Fluid) Between Groups at 48 Hours Post-op | 48 hours | Comparison of proBNP levels in pericardial fluid between groups at 48 hours post-op. |
| C-reactive Protein (Pericardial Fluid) Between Groups at 48 Hours Post-op | 48 hours | Comparison of CRP levels in pericardial fluid between groups at 48 hours post-op |
| Interleukin-6 (Pericardial Fluid) Between Groups at 48 Hours Post-op | 48 hours | Comparison of IL-6 levels in pericardial fluid between groups at 48 hours post-op |
| Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 48 Hours Post-op | 48 hours | Comparison of TNFa levels in pericardial fluid between groups at 48 hours post-op |
| proBNP (Pericardial Fluid) Between Groups at 72 Hours Post-op | 72 hours | Comparison of proBNP levels in pericardial fluid between groups at 72 hours post-op |
| C-reactive Protein (Pericardial Fluid) Between Groups at 72 Hours Post-op | 72 hours | Comparison of CRP levels in pericardial fluid between groups at 72 hours post-op |
| Interleukin-6 (Pericardial Fluid) Between Groups at 72 Hours Post-op | 72 hours | Comparison of IL-6 levels in pericardial fluid between groups at 72 hours post-op |
| Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 72 Hours Post-op | 72 hours | Comparison of TNFa levels in pericardial fluid between groups at 72 hours post-op |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVikas Sharma, MD
University of Utah
Participant flow
Recruitment details
Recruitment in a University hospital (inpatient, outpatient clinics) from October 2019 through May 2021
Pre-assignment details
One participant was enrolled and randomized to receive the intervention, but they ultimately did not have the membrane placed due to a miscommunication in the OR. This is the reason that 27 participants were enrolled but the total number for analysis was 26.
Participants by arm
| Arm | Count |
|---|---|
| Randomized Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane | 12 |
| Control Patients undergoing isolated CABG surgery who are randomized to receive standard of care | 14 |
| Total | 26 |
Baseline characteristics
| Characteristic | Randomized | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 6 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 8 Participants | 14 Participants |
| Age, Continuous | 64.91 years | 65.78 years | 65.38 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 13 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 11 Participants | 13 Participants | 24 Participants |
| Region of Enrollment United States | 12 participants | 14 participants | 26 participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 14 |
| other Total, other adverse events | 0 / 12 | 0 / 14 |
| serious Total, serious adverse events | 0 / 12 | 0 / 14 |
Outcome results
Primary
C-reactive Protein (Pericardial Fluid) Between Groups at 24 Hours Post-op
Comparison of CRP levels in pericardial fluid between groups at 24 hours post-op
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | C-reactive Protein (Pericardial Fluid) Between Groups at 24 Hours Post-op | 4.54 mg/dL | Standard Deviation 2.51 |
| Control | C-reactive Protein (Pericardial Fluid) Between Groups at 24 Hours Post-op | 2.84 mg/dL | Standard Deviation 2.05 |
Primary
C-reactive Protein (Pericardial Fluid) Between Groups at 48 Hours Post-op
Comparison of CRP levels in pericardial fluid between groups at 48 hours post-op
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | C-reactive Protein (Pericardial Fluid) Between Groups at 48 Hours Post-op | 6.8 mg/dL | Standard Deviation 3.72 |
| Control | C-reactive Protein (Pericardial Fluid) Between Groups at 48 Hours Post-op | 4.9 mg/dL | Standard Deviation 2.52 |
Primary
C-reactive Protein (Pericardial Fluid) Between Groups at 72 Hours Post-op
Comparison of CRP levels in pericardial fluid between groups at 72 hours post-op
Time frame: 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | C-reactive Protein (Pericardial Fluid) Between Groups at 72 Hours Post-op | 8.53 mg/dL | Standard Deviation 3.89 |
| Control | C-reactive Protein (Pericardial Fluid) Between Groups at 72 Hours Post-op | 6.35 mg/dL | Standard Deviation 3.1 |
Primary
C-reactive Protein (Pericardial Fluid) Between Groups at Time of Surgery
Comparison of CRP levels in pericardial fluid between groups at the time of surgery (baseline).
Time frame: Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | C-reactive Protein (Pericardial Fluid) Between Groups at Time of Surgery | 0.34 mg/dL | Standard Deviation 0.32 |
| Control | C-reactive Protein (Pericardial Fluid) Between Groups at Time of Surgery | 0.39 mg/dL | Standard Deviation 0.87 |
Primary
C-reactive Protein (Serum) Between Groups at 24-hours Post-op
Comparison of serum measurements of CRP between groups at 24 hours post-op
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | C-reactive Protein (Serum) Between Groups at 24-hours Post-op | 14.94 mg/dL | Standard Deviation 5.94 |
| Control | C-reactive Protein (Serum) Between Groups at 24-hours Post-op | 10.66 mg/dL | Standard Deviation 4.58 |
Primary
C-reactive Protein (Serum) Between Groups at 48 Hours Post-op
Comparison of serum CRP levels between groups at 48 hours post-op
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | C-reactive Protein (Serum) Between Groups at 48 Hours Post-op | 21.67 mg/dL | Standard Deviation 8.18 |
| Control | C-reactive Protein (Serum) Between Groups at 48 Hours Post-op | 15.71 mg/dL | Standard Deviation 6.97 |
Primary
C-reactive Protein (Serum) Between Groups at Time of Surgery
Comparison of serum levels of CRP between groups at the time of surgery (baseline).
Time frame: Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | C-reactive Protein (Serum) Between Groups at Time of Surgery | 0.34 mg/dL | Standard Deviation 0.32 |
| Control | C-reactive Protein (Serum) Between Groups at Time of Surgery | 0.39 mg/dL | Standard Deviation 0.87 |
Primary
CRP (Serum) Between Groups at 72 Hours Post-op
Comparison of serum levels of CRP between groups at 72 hour post-op
Time frame: 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | CRP (Serum) Between Groups at 72 Hours Post-op | 17.45 mg/dL | Standard Deviation 5.95 |
| Control | CRP (Serum) Between Groups at 72 Hours Post-op | 14.21 mg/dL | Standard Deviation 5.19 |
Primary
CRP (Serum) Between Groups at Follow-Up
Comparison of serum CRP levels between groups at follow-up
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | CRP (Serum) Between Groups at Follow-Up | 0.975 mg/dL | Standard Deviation 0.49 |
| Control | CRP (Serum) Between Groups at Follow-Up | 1.96 mg/dL | Standard Deviation 3.61 |
Primary
Interleukin-6 (Pericardial Fluid) Between Groups at 24 Hours Post-op
Comparison of IL-6 levels in pericardial fluid between groups at 24 hours post-op
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | Interleukin-6 (Pericardial Fluid) Between Groups at 24 Hours Post-op | 88823.8 pg/mL | Standard Deviation 51901.4 |
| Control | Interleukin-6 (Pericardial Fluid) Between Groups at 24 Hours Post-op | 67217.8 pg/mL | Standard Deviation 48407.4 |
Primary
Interleukin-6 (Pericardial Fluid) Between Groups at 48 Hours Post-op
Comparison of IL-6 levels in pericardial fluid between groups at 48 hours post-op
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | Interleukin-6 (Pericardial Fluid) Between Groups at 48 Hours Post-op | 64370.14 pg/mL | Standard Deviation 57497 |
| Control | Interleukin-6 (Pericardial Fluid) Between Groups at 48 Hours Post-op | 45839.95 pg/mL | Standard Deviation 43229.37 |
Primary
Interleukin-6 (Pericardial Fluid) Between Groups at 72 Hours Post-op
Comparison of IL-6 levels in pericardial fluid between groups at 72 hours post-op
Time frame: 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | Interleukin-6 (Pericardial Fluid) Between Groups at 72 Hours Post-op | 9296.6 pg/mL | Standard Deviation 9514 |
| Control | Interleukin-6 (Pericardial Fluid) Between Groups at 72 Hours Post-op | 25316.6 pg/mL | Standard Deviation 39863.65 |
Primary
Interleukin-6 (Pericardial Fluid) Between Groups at Time of Surgery
Comparison of IL-6 levels in pericardial fluid between groups at the time of surgery (baseline).
Time frame: Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | Interleukin-6 (Pericardial Fluid) Between Groups at Time of Surgery | 30.3 pg/mL | Standard Deviation 26.17 |
| Control | Interleukin-6 (Pericardial Fluid) Between Groups at Time of Surgery | 59.9 pg/mL | Standard Deviation 122.83 |
Primary
Interleukin-6 (Serum) Between Groups at 24-hours Post-op
Comparison of IL-6 serum levels between groups at 24 hours post-op
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | Interleukin-6 (Serum) Between Groups at 24-hours Post-op | 26.95 pg/mL | Standard Deviation 22.36 |
| Control | Interleukin-6 (Serum) Between Groups at 24-hours Post-op | 18.28 pg/mL | Standard Deviation 12.03 |
Primary
Interleukin-6 (Serum) Between Groups at 48 Hours Post-op
Comparison of IL-6 serum results between groups at 48 hours post-op
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | Interleukin-6 (Serum) Between Groups at 48 Hours Post-op | 12.32 pg/mL | Standard Deviation 10.01 |
| Control | Interleukin-6 (Serum) Between Groups at 48 Hours Post-op | 14.39 pg/mL | Standard Deviation 10.23 |
Primary
Interleukin-6 (Serum) Between Groups at 72 Hours Post-op
Comparison of IL-6 serum levels between groups at 72 hours post-op
Time frame: 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | Interleukin-6 (Serum) Between Groups at 72 Hours Post-op | 5.81 pg/mL | Standard Deviation 4.15 |
| Control | Interleukin-6 (Serum) Between Groups at 72 Hours Post-op | 10.38 pg/mL | Standard Deviation 8.85 |
Primary
Interleukin-6 (Serum) Between Groups at Follow-up
Comparison of IL-6 serum levels between groups at follow-up
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | Interleukin-6 (Serum) Between Groups at Follow-up | 2.37 pg/mL | Standard Deviation 1.06 |
| Control | Interleukin-6 (Serum) Between Groups at Follow-up | 6.86 pg/mL | Standard Deviation 15.36 |
Primary
Interleukin-6 (Serum) Between Groups at Time of Surgery
Comparison of serum measurement of IL-6 between groups at the time of surgery (baseline).
Time frame: Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | Interleukin-6 (Serum) Between Groups at Time of Surgery | 2.25 pg/mL | Standard Deviation 0.86 |
| Control | Interleukin-6 (Serum) Between Groups at Time of Surgery | 2.23 pg/mL | Standard Deviation 0.83 |
Primary
Number of Participants With Adverse Events
The AM applied epicardially will be assessed for signs of hyperacute rejection i.e. membrane changing color; cardiac tamponade or constriction assessed by echocardiogram and transmission of infectious diseases. The incidence of adverse events (AEs) will be reported as percentages, with two-sided 95% confidence intervals. Statistical comparisons of AEs between the AM treatment and the control group will be made using a chi-square, or Fisher's exact test, as appropriate (based on the minimum expected cell frequencies).
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Randomized | Number of Participants With Adverse Events | 0 Participants |
| Control | Number of Participants With Adverse Events | 0 Participants |
Primary
Number of Participants With Post Op Atrial Fibrillation Between Patients Who Receive hAM and Controls
The number of patients with Post Op Atrial Fibrillation will be compared between the treatment and control group using mobile telemetry. This comparison will be analyzed using chi-square or Fisher's exact test as appropriate.
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Randomized | Number of Participants With Post Op Atrial Fibrillation Between Patients Who Receive hAM and Controls | 5 Participants |
| Control | Number of Participants With Post Op Atrial Fibrillation Between Patients Who Receive hAM and Controls | 6 Participants |
Primary
proBNP (Pericardial Fluid) Between Groups at 24 Hours Post-op
Comparison of levels of proBNP in pericardial fluid between groups at 24 hours post-op
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | proBNP (Pericardial Fluid) Between Groups at 24 Hours Post-op | 6081.83 pg/mL | Standard Deviation 5134.12 |
| Control | proBNP (Pericardial Fluid) Between Groups at 24 Hours Post-op | 7750.35 pg/mL | Standard Deviation 7474.25 |
Primary
proBNP (Pericardial Fluid) Between Groups at 48 Hours Post-op
Comparison of proBNP levels in pericardial fluid between groups at 48 hours post-op.
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | proBNP (Pericardial Fluid) Between Groups at 48 Hours Post-op | 8823.4 pg/mL | Standard Deviation 9286.9 |
| Control | proBNP (Pericardial Fluid) Between Groups at 48 Hours Post-op | 10027.57 pg/mL | Standard Deviation 7189.94 |
Primary
proBNP (Pericardial Fluid) Between Groups at 72 Hours Post-op
Comparison of proBNP levels in pericardial fluid between groups at 72 hours post-op
Time frame: 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | proBNP (Pericardial Fluid) Between Groups at 72 Hours Post-op | 3895.5 pg/mL | Standard Deviation 1458.8 |
| Control | proBNP (Pericardial Fluid) Between Groups at 72 Hours Post-op | 8423 pg/mL | Standard Deviation 5911.3 |
Primary
proBNP (Pericardial Fluid) Between Groups at Time of Surgery
Comparison of proBNP levels in pericardial fluid between groups at time of surgery (baseline)
Time frame: Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | proBNP (Pericardial Fluid) Between Groups at Time of Surgery | 1039.6 pg/mL | Standard Deviation 819.58 |
| Control | proBNP (Pericardial Fluid) Between Groups at Time of Surgery | 1771.07 pg/mL | Standard Deviation 2332.54 |
Primary
proBNP (Serum) Between Groups at 24 Hours Post-op
Comparison of serum proBNP levels between groups at 24 hours post-op
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | proBNP (Serum) Between Groups at 24 Hours Post-op | 1922.83 pg/mL | Standard Deviation 1017.9 |
| Control | proBNP (Serum) Between Groups at 24 Hours Post-op | 2239.42 pg/mL | Standard Deviation 2384.3 |
Primary
proBNP (Serum) Between Groups at 48 Hours Post-op
Comparison of serum levels of proBNP between groups at 48 hours post-op
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | proBNP (Serum) Between Groups at 48 Hours Post-op | 6081.83 pg/mL | Standard Deviation 5134.12 |
| Control | proBNP (Serum) Between Groups at 48 Hours Post-op | 7750.35 pg/mL | Standard Deviation 7474.25 |
Primary
proBNP (Serum) Between Groups at 72 Hours Post-op
Comparison of serum levels of proBNP between groups at 72 hour post-op
Time frame: 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | proBNP (Serum) Between Groups at 72 Hours Post-op | 2707.75 pg/mL | Standard Deviation 925.9 |
| Control | proBNP (Serum) Between Groups at 72 Hours Post-op | 449.71 pg/mL | Standard Deviation 6191.8 |
Primary
proBNP (Serum) Between Groups at Follow-up
Comparison of serum levels of proBNP between groups at follow-up
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | proBNP (Serum) Between Groups at Follow-up | 847 pg/mL | Standard Deviation 505.79 |
| Control | proBNP (Serum) Between Groups at Follow-up | 1391.7 pg/mL | Standard Deviation 1336.8 |
Primary
proBNP (Serum) Between Groups at Time of Surgery
Comparison of serum levels of proBNP between groups at the time of surgery (baseline).
Time frame: Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | proBNP (Serum) Between Groups at Time of Surgery | 198 pg/mL | Standard Deviation 263 |
| Control | proBNP (Serum) Between Groups at Time of Surgery | 347 pg/mL | Standard Deviation 523 |
Primary
TNFa (Serum) Between Groups at 72 Hours Post-op
Comparison of TNFa serum levels between groups at 72 hours post-op
Time frame: 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | TNFa (Serum) Between Groups at 72 Hours Post-op | 2.12 pg/mL | Standard Deviation 1.26 |
| Control | TNFa (Serum) Between Groups at 72 Hours Post-op | 2.38 pg/mL | Standard Deviation 1.56 |
Primary
TNFa (Serum) Between Groups at Follow-up
Comparison of TNFa serum levels between groups at follow-up
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | TNFa (Serum) Between Groups at Follow-up | 2.11 pg/mL | Standard Deviation 1.16 |
| Control | TNFa (Serum) Between Groups at Follow-up | 3.11 pg/mL | Standard Deviation 2.93 |
Primary
Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 24 Hours Post-op
Comparison of TNFa in pericardial fluid between groups at 24 hours post-op.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 24 Hours Post-op | 8.58 pg/mL | Standard Deviation 5.61 |
| Control | Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 24 Hours Post-op | 10.35 pg/mL | Standard Deviation 8.04 |
Primary
Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 48 Hours Post-op
Comparison of TNFa levels in pericardial fluid between groups at 48 hours post-op
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 48 Hours Post-op | 8.3 pg/mL | Standard Deviation 7.81 |
| Control | Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 48 Hours Post-op | 8.03 pg/mL | Standard Deviation 5.34 |
Primary
Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 72 Hours Post-op
Comparison of TNFa levels in pericardial fluid between groups at 72 hours post-op
Time frame: 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 72 Hours Post-op | 12.32 pg/mL | Standard Deviation 13.44 |
| Control | Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 72 Hours Post-op | 8.38 pg/mL | Standard Deviation 4.41 |
Primary
Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at Time of Surgery
Comparison of TNFa in pericardial fluid between groups at the time of surgery (baseline).
Time frame: Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at Time of Surgery | 2.81 pg/mL | Standard Deviation 2.72 |
| Control | Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at Time of Surgery | 2.77 pg/mL | Standard Deviation 2.46 |
Primary
Tumor Necrosis Factor - Alpha (Serum) Between Groups at 48 Hours Post-op
Comparison of serum TNFa levels between groups at 48 hours post-op
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | Tumor Necrosis Factor - Alpha (Serum) Between Groups at 48 Hours Post-op | 2.34 pg/mL | Standard Deviation 1.51 |
| Control | Tumor Necrosis Factor - Alpha (Serum) Between Groups at 48 Hours Post-op | 2.27 pg/mL | Standard Deviation 1.09 |
Primary
Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at 24 Hours Post-op
Comparison of serum levels of TNFa between groups at 24 hours post-op
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at 24 Hours Post-op | 2.61 pg/mL | Standard Deviation 1.22 |
| Control | Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at 24 Hours Post-op | 2.87 pg/mL | Standard Deviation 2.72 |
Primary
Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at Time of Surgery
Comparison of serum levels of TNFa between groups at the time of surgery (baseline).
Time frame: Surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized | Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at Time of Surgery | 2.45 pg/mL | Standard Deviation 1.56 |
| Control | Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at Time of Surgery | 3.63 pg/mL | Standard Deviation 3.04 |