Cardiac Disease, Cardiac Output, High, Cardiac Output, Low, Fluid Loss, Fluid Overload, Volume Overload
Conditions
Keywords
fluid responsiveness, fluid status, cardiac surgery, volemic status, pro-ANP, hemodynamic monitoring, functional test, teboul test, stroke volume variation, cardiac output
Brief summary
Biomarkers can play a significant role in fluid status assessment intraoperatively.
Detailed description
Routinely intraoperatively the fluid status assessment is based on central venous pressure and other parameters. Nevertheless, the minority of anesthesiologists use continous dynamic parameters like pulse pressure variation, stroke volume variation and other to manage fluid status. There's a fast acting biomarker that can help anesthesiologist to diagnose and manage the volemic status and possibly guide the infusion therapy better. Pro-ANP is a biomarker that reacts on atria strain and can be used in volemic status assessment in cardiac surgery patients.
Interventions
DIAGNOSTIC_TESTpro-ANP
pro-ANP samples and fluid status assessment with functional tests (Teboul test) will be used 8 times intraoperatively.
Sponsors
Petrovsky National Research Centre of Surgery
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
CABG, one-, two valve repair/replacement, ascending aorta, aortic arch replacement, ASD/AVD closure, septal myectomy
Exclusion criteria
1. Atrial fibrillation, atrial flutter, frequent ventricular and supraventricular arrythmias 2. EFLV \< 50% 3. Pulmonary hypertension \> 2 st 4. CKD \> C3 (GFR \< 30) 5. Redo surgery 6. Left atrium volume \> 150 ml 7. LV EDV \> 250 ml
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Pro-ANP Twofold Raise by the End of Surgery | intraoperatively | To assess the atria strain and consequent rise of pro-ANP by the end of surgery |
| Number of Patients With Pro-ANP Increase > 10% by the PLR Maneuver | intraoperative | According to positive PLR the assessment of pro-ANP consequent raise |
| Number of Patients With Cardiac Index Rise > 10% After Passive Leg Raising Maneuver | 10 minutes of PLR test | Using Massimo vigileo hard- and software the first assessment of cardiac index was made before Teboul test after the trachea intubation. After 10 minutes of passive leg raising maneuver second assessment. If raise in cardiac index above 10 percent was detected the patient was considered a responder. If not - non-responder. |
| Number of Patients With Pro-ANP Increase > 10% by the PLR Maneuver at the End of Surgery | 10 minutes of PLR test | Using Massimo vigileo hard- and software the assessment of cardiac index was made before Teboul test at the end of surgery before leaving the operating room. After 10 minutes of passive leg raising maneuver second assessment. If raise in cardiac index above 10 percent was detected the patient was considered a responder. If not - non-responder. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal Failure | up to 10 days | Number of patients who require extracorporeal detoxication |
| Heart Failure | up to 10 days | Need in medicamental cardiotonic support more than 1 day |
| Postoperative Complications | up to 10 days | Total amount of various postoperative complications |
| Infection Rate | up to 10 days | Number of patients who develop systemic infection and/or operation wound infection |
| Length of Intensive Care Stay | up to 10 days | Duration of summarized length in ICU, including readmission to ICU |
| Circulatory Insufficiency | up to 10 days | Need in medicamental vasopressor support more than 1 day |
| Mortality | up to 10 days | Mortality rate |
| Multiorgan Failure | up to 10 days | Number of more than 2 organs failure |
| Respiratory Failure | up to 10 days | Number of patients who require prolonged and/or repeated artificial lung ventilation |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cardiac Surgery Patients 30 patients enrolled in a study | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Cardiac Surgery Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Age, Continuous | 58 years STANDARD_DEVIATION 13 |
| Body surface area, м² | 2 square meters STANDARD_DEVIATION 0.23 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Region of Enrollment Russia | 30 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Number of Patients With Cardiac Index Rise > 10% After Passive Leg Raising Maneuver
Using Massimo vigileo hard- and software the first assessment of cardiac index was made before Teboul test after the trachea intubation. After 10 minutes of passive leg raising maneuver second assessment. If raise in cardiac index above 10 percent was detected the patient was considered a responder. If not - non-responder.
Time frame: 10 minutes of PLR test
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cardiac Surgery Patients | Number of Patients With Cardiac Index Rise > 10% After Passive Leg Raising Maneuver | 5 Responders |
Primary
Number of Patients With Pro-ANP Increase > 10% by the PLR Maneuver
According to positive PLR the assessment of pro-ANP consequent raise
Time frame: intraoperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardiac Surgery Patients | Number of Patients With Pro-ANP Increase > 10% by the PLR Maneuver | 5 Participants |
Primary
Number of Patients With Pro-ANP Increase > 10% by the PLR Maneuver at the End of Surgery
Using Massimo vigileo hard- and software the assessment of cardiac index was made before Teboul test at the end of surgery before leaving the operating room. After 10 minutes of passive leg raising maneuver second assessment. If raise in cardiac index above 10 percent was detected the patient was considered a responder. If not - non-responder.
Time frame: 10 minutes of PLR test
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cardiac Surgery Patients | Number of Patients With Pro-ANP Increase > 10% by the PLR Maneuver at the End of Surgery | 8 Responders |
Primary
Number of Patients With Pro-ANP Twofold Raise by the End of Surgery
To assess the atria strain and consequent rise of pro-ANP by the end of surgery
Time frame: intraoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardiac Surgery Patients | Number of Patients With Pro-ANP Twofold Raise by the End of Surgery | 17 Participants |
Secondary
Circulatory Insufficiency
Need in medicamental vasopressor support more than 1 day
Time frame: up to 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardiac Surgery Patients | Circulatory Insufficiency | 3 Participants |
Secondary
Heart Failure
Need in medicamental cardiotonic support more than 1 day
Time frame: up to 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardiac Surgery Patients | Heart Failure | 1 Participants |
Secondary
Infection Rate
Number of patients who develop systemic infection and/or operation wound infection
Time frame: up to 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardiac Surgery Patients | Infection Rate | 0 Participants |
Secondary
Length of Intensive Care Stay
Duration of summarized length in ICU, including readmission to ICU
Time frame: up to 10 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cardiac Surgery Patients | Length of Intensive Care Stay | 22 hours |
Secondary
Mortality
Mortality rate
Time frame: up to 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardiac Surgery Patients | Mortality | 0 Participants |
Secondary
Multiorgan Failure
Number of more than 2 organs failure
Time frame: up to 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardiac Surgery Patients | Multiorgan Failure | 0 Participants |
Secondary
Postoperative Complications
Total amount of various postoperative complications
Time frame: up to 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardiac Surgery Patients | Postoperative Complications | 8 Participants |
Secondary
Renal Failure
Number of patients who require extracorporeal detoxication
Time frame: up to 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardiac Surgery Patients | Renal Failure | 0 Participants |
Secondary
Respiratory Failure
Number of patients who require prolonged and/or repeated artificial lung ventilation
Time frame: up to 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cardiac Surgery Patients | Respiratory Failure | 0 Participants |