Fluid Therapy, Goal Directed Therapy
Conditions
Keywords
cardiac output, perioperative care, postoperative complications
Brief summary
The primary aim of this study is to quantify and compare the hemodynamic control of cardiac index in patients who receive either goal-directed therapy or standard hemodynamic management in lung resection surgery
Detailed description
The investigators hypothesize that the percentage of the intraoperative time in which the cardiac index is equal or superior to 2.2 l/min/m2 is higher in goal directed therapy
Interventions
PROCEDUREStandard care
Heart rate 60-100 beats per minute, mean arterial pressure 65 mm Hg, serum lactate 2 mmol/L, oxygen saturation 95 % (90 % during one lung ventilation).
PROCEDUREGoal directed therapy
The hemodynamic algorithm will be based on systolic volume index and fluid challenges. FloTrac sensor (this sensor connects to any existing arterial catheter and provides advanced hemodynamic parameters through pulse contour analysis) and EV1000 clinical platform (clinical platform from Edwards Lifesciences that provides advanced hemodynamic monitoring) will be used to calculate cardiac index and systolic volume index.
Sponsors
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults patients ( 18 years old) * Written informed consent * Elective lung resection surgery (open or thoracoscopic lung lobectomy)
Exclusion criteria
* Severe obesity * Moderate to severe aortic insufficiency * Renal failure requiring hemodialysis * Left ventricle ejection fraction less than 35 % * Urgent surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of the Intraoperative Time in Which the Cardiac Index is Equal or Superior to 2.2 l/Min/m2 (%) | During the total duration of the surgery, on average 4 hours. We include the time from the start of maintenance of general anesthesia to the moment of extubation of the patient. | To compare the degree of hemodynamic control of cardiac index in both groups: Percentage of the intraoperative time in which the cardiac index is equal or superior to 2.2 l/min/m2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tissue Perfusion Marker: SvcO2 | Within 24 hours after lung surgery | To compare SvcO2 (central venous oxygen saturation) in the first 24 hours in both groups |
| Oxygenation Marker: PaO2/FiO2 Ratio | Within 24 hours after lung surgery | To compare PaO2/FiO2 ratio (ratio of arterial oxygen partial pressure to fractional inspired oxygen) in the first 24 hours in both groups |
| Fluid Balance | After 24 hours of finalization of lung surgery | To compare fluid balance (differences between the amount of water taken into the body and the amount excreted or lost) in the first 24 hours in both groups |
| Tissue Perfusion Marker: Lactate | Within 24 hours after lung surgery | To compare lactate in the first 24 hours in both groups |
| Observation of Acute Respiratory Distress Syndrome (ARDS) | Within 30 days after lung surgery | To compare the he Number of Participants with Acute Respiratory Distress Syndrome in both groups |
| Duration of Hospital Stay | Within 30 days after lung surgery | To compare hospital stay in both groups |
| Mortality | Within 30 days after lung surgery | To compare the mortality rate in both groups |
| Observation of Acute Kidney Injury (AKI) | After 72 hours of finalization of lung surgery | To compare the Number of Participants with Acute Kidney Injury in both groups |
Countries
Spain
Participant flow
Pre-assignment details
31 patients signed informed consent, but there was a pre-randomization exclusion (a patient was selected and signed informed consent) because surgeons decided to carry out a less aggressive surgery from the start (atypical lung resection instead of lobectomy). That happened in only one case.
Participants by arm
| Arm | Count |
|---|---|
| Standard Care Basic intraoperative hemodynamic objectives
Standard care: Heart rate 60-100 beats per minute, mean arterial pressure 65 mm Hg, serum lactate 2 mmol/L, oxygen saturation 95 % (90 % during one lung ventilation). | 15 |
| Goal Directed Therapy Target value is a cardiac index equal or superior to 2.2 l/min/m2.
Goal directed therapy: The hemodynamic algorithm will be based on systolic volume index and fluid challenges. FloTrac sensor (this sensor connects to any existing arterial catheter and provides advanced hemodynamic parameters through pulse contour analysis) and EV1000 clinical platform (clinical platform from Edwards Lifesciences that provides advanced hemodynamic monitoring) will be used to calculate cardiac index and systolic volume index. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Total | Goal Directed Therapy | Standard Care |
|---|---|---|---|
| Age, Continuous | 67.37 years STANDARD_DEVIATION 9.137 | 67.33 years STANDARD_DEVIATION 8.64 | 67.4 years STANDARD_DEVIATION 9.91 |
| ASA Physical Status Classification System ASA II | 11 Participants | 8 Participants | 3 Participants |
| ASA Physical Status Classification System ASA III | 19 Participants | 7 Participants | 12 Participants |
| Atrial fibrillation | 3 Participants | 1 Participants | 2 Participants |
| Body Mass Index (BMI) | 25.3 kg/m^2 STANDARD_DEVIATION 3.89 | 24.64 kg/m^2 STANDARD_DEVIATION 3.39 | 25.96 kg/m^2 STANDARD_DEVIATION 4.35 |
| cerebrovascular disease | 3 Participants | 1 Participants | 2 Participants |
| Chronic kidney disease | 5 Participants | 3 Participants | 2 Participants |
| COPD grade GOLD is equal or superior to 2 | 5 Participants | 3 Participants | 2 Participants |
| Diabetes Mellitus | 7 Participants | 4 Participants | 3 Participants |
| Dyslipidemia | 16 Participants | 7 Participants | 9 Participants |
| Hypertension | 20 Participants | 11 Participants | 9 Participants |
| Ischemic heart disease | 3 Participants | 3 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 30 Participants | 15 Participants | 15 Participants |
| Region of Enrollment Spain | 30 participants | 15 participants | 15 participants |
| Sex: Female, Male Female | 6 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 24 Participants | 13 Participants | 11 Participants |
| Smoking exposure | 33.93 pack-years STANDARD_DEVIATION 25.85 | 34.07 pack-years STANDARD_DEVIATION 20.15 | 33.79 pack-years STANDARD_DEVIATION 31.27 |
| Smoking history | 25 Participants | 13 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 15 | 0 / 15 |
| other Total, other adverse events | 12 / 15 | 14 / 15 |
| serious Total, serious adverse events | 3 / 15 | 4 / 15 |
Outcome results
Primary
Percentage of the Intraoperative Time in Which the Cardiac Index is Equal or Superior to 2.2 l/Min/m2 (%)
To compare the degree of hemodynamic control of cardiac index in both groups: Percentage of the intraoperative time in which the cardiac index is equal or superior to 2.2 l/min/m2.
Time frame: During the total duration of the surgery, on average 4 hours. We include the time from the start of maintenance of general anesthesia to the moment of extubation of the patient.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Care | Percentage of the Intraoperative Time in Which the Cardiac Index is Equal or Superior to 2.2 l/Min/m2 (%) | 97 percentage of time |
| Goal Directed Therapy | Percentage of the Intraoperative Time in Which the Cardiac Index is Equal or Superior to 2.2 l/Min/m2 (%) | 91 percentage of time |
p-value: 0.114Wilcoxon (Mann-Whitney)
Secondary
Duration of Hospital Stay
To compare hospital stay in both groups
Time frame: Within 30 days after lung surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Care | Duration of Hospital Stay | 4 days |
| Goal Directed Therapy | Duration of Hospital Stay | 5 days |
p-value: 0.229Wilcoxon (Mann-Whitney)
Secondary
Fluid Balance
To compare fluid balance (differences between the amount of water taken into the body and the amount excreted or lost) in the first 24 hours in both groups
Time frame: After 24 hours of finalization of lung surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Fluid Balance | 647.17 milliliters | Standard Deviation 700.57 |
| Goal Directed Therapy | Fluid Balance | 748.83 milliliters | Standard Deviation 579.46 |
p-value: 0.668t-test, 2 sided
Secondary
Mortality
To compare the mortality rate in both groups
Time frame: Within 30 days after lung surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Mortality | 1 Participants |
| Goal Directed Therapy | Mortality | 0 Participants |
p-value: 1Fisher Exact
Secondary
Observation of Acute Kidney Injury (AKI)
To compare the Number of Participants with Acute Kidney Injury in both groups
Time frame: After 72 hours of finalization of lung surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Observation of Acute Kidney Injury (AKI) | 3 Participants |
| Goal Directed Therapy | Observation of Acute Kidney Injury (AKI) | 5 Participants |
p-value: 0.516Chi-squared
Secondary
Observation of Acute Respiratory Distress Syndrome (ARDS)
To compare the he Number of Participants with Acute Respiratory Distress Syndrome in both groups
Time frame: Within 30 days after lung surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Observation of Acute Respiratory Distress Syndrome (ARDS) | 0 Participants |
| Goal Directed Therapy | Observation of Acute Respiratory Distress Syndrome (ARDS) | 0 Participants |
Secondary
Oxygenation Marker: PaO2/FiO2 Ratio
To compare PaO2/FiO2 ratio (ratio of arterial oxygen partial pressure to fractional inspired oxygen) in the first 24 hours in both groups
Time frame: Within 24 hours after lung surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Care | Oxygenation Marker: PaO2/FiO2 Ratio | 331.43 mm Hg |
| Goal Directed Therapy | Oxygenation Marker: PaO2/FiO2 Ratio | 339.05 mm Hg |
p-value: 0.443Wilcoxon (Mann-Whitney)
Secondary
Tissue Perfusion Marker: Lactate
To compare lactate in the first 24 hours in both groups
Time frame: Within 24 hours after lung surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Care | Tissue Perfusion Marker: Lactate | 0.70 mmol/L |
| Goal Directed Therapy | Tissue Perfusion Marker: Lactate | 0.80 mmol/L |
p-value: 0.692Wilcoxon (Mann-Whitney)
Secondary
Tissue Perfusion Marker: SvcO2
To compare SvcO2 (central venous oxygen saturation) in the first 24 hours in both groups
Time frame: Within 24 hours after lung surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Tissue Perfusion Marker: SvcO2 | 66.03 percentage of saturation | Standard Deviation 7.16 |
| Goal Directed Therapy | Tissue Perfusion Marker: SvcO2 | 70.16 percentage of saturation | Standard Deviation 5.14 |
p-value: 0.082t-test, 2 sided