Trial Outcomes & Findings for Goal Directed Therapy Versus Standard Care in Lung Resection Surgery (GDT-thorax Study). (NCT NCT03245372)
NCT ID: NCT03245372
Last Updated: 2021-10-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
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.
Results posted on
2021-10-20
Participant Flow
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.
Participant milestones
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Goal Directed Therapy Versus Standard Care in Lung Resection Surgery (GDT-thorax Study).
Baseline characteristics by cohort
| Measure |
Standard Care
n=15 Participants
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).
|
Goal Directed Therapy
n=15 Participants
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.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.4 years
STANDARD_DEVIATION 9.91 • n=5 Participants
|
67.33 years
STANDARD_DEVIATION 8.64 • n=7 Participants
|
67.37 years
STANDARD_DEVIATION 9.137 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
25.96 kg/m^2
STANDARD_DEVIATION 4.35 • n=5 Participants
|
24.64 kg/m^2
STANDARD_DEVIATION 3.39 • n=7 Participants
|
25.3 kg/m^2
STANDARD_DEVIATION 3.89 • n=5 Participants
|
|
Smoking history
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Smoking exposure
|
33.79 pack-years
STANDARD_DEVIATION 31.27 • n=5 Participants
|
34.07 pack-years
STANDARD_DEVIATION 20.15 • n=7 Participants
|
33.93 pack-years
STANDARD_DEVIATION 25.85 • n=5 Participants
|
|
ASA Physical Status Classification System
ASA II
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
ASA Physical Status Classification System
ASA III
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Hypertension
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Dyslipidemia
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Diabetes Mellitus
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ischemic heart disease
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Atrial fibrillation
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Chronic kidney disease
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
COPD grade GOLD is equal or superior to 2
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
cerebrovascular disease
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Standard Care
n=15 Participants
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).
|
Goal Directed Therapy
n=15 Participants
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.
|
|---|---|---|
|
Percentage of the Intraoperative Time in Which the Cardiac Index is Equal or Superior to 2.2 l/Min/m2 (%)
|
97 percentage of time
Interval 92.0 to 99.0
|
91 percentage of time
Interval 79.0 to 98.0
|
SECONDARY outcome
Timeframe: Within 24 hours after lung surgeryTo compare lactate in the first 24 hours in both groups
Outcome measures
| Measure |
Standard Care
n=15 Participants
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).
|
Goal Directed Therapy
n=15 Participants
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.
|
|---|---|---|
|
Tissue Perfusion Marker: Lactate
|
0.70 mmol/L
Interval 0.5 to 1.2
|
0.80 mmol/L
Interval 0.6 to 1.0
|
SECONDARY outcome
Timeframe: Within 24 hours after lung surgeryTo compare SvcO2 (central venous oxygen saturation) in the first 24 hours in both groups
Outcome measures
| Measure |
Standard Care
n=15 Participants
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).
|
Goal Directed Therapy
n=15 Participants
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.
|
|---|---|---|
|
Tissue Perfusion Marker: SvcO2
|
66.03 percentage of saturation
Standard Deviation 7.16
|
70.16 percentage of saturation
Standard Deviation 5.14
|
SECONDARY outcome
Timeframe: Within 24 hours after lung surgeryTo compare PaO2/FiO2 ratio (ratio of arterial oxygen partial pressure to fractional inspired oxygen) in the first 24 hours in both groups
Outcome measures
| Measure |
Standard Care
n=15 Participants
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).
|
Goal Directed Therapy
n=15 Participants
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.
|
|---|---|---|
|
Oxygenation Marker: PaO2/FiO2 Ratio
|
331.43 mm Hg
Interval 286.66 to 398.09
|
339.05 mm Hg
Interval 301.43 to 390.47
|
SECONDARY outcome
Timeframe: After 24 hours of finalization of lung surgeryTo 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
Outcome measures
| Measure |
Standard Care
n=15 Participants
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).
|
Goal Directed Therapy
n=15 Participants
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.
|
|---|---|---|
|
Fluid Balance
|
647.17 milliliters
Standard Deviation 700.57
|
748.83 milliliters
Standard Deviation 579.46
|
SECONDARY outcome
Timeframe: After 72 hours of finalization of lung surgeryTo compare the Number of Participants with Acute Kidney Injury in both groups
Outcome measures
| Measure |
Standard Care
n=15 Participants
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).
|
Goal Directed Therapy
n=15 Participants
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.
|
|---|---|---|
|
Observation of Acute Kidney Injury (AKI)
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Within 30 days after lung surgeryTo compare the he Number of Participants with Acute Respiratory Distress Syndrome in both groups
Outcome measures
| Measure |
Standard Care
n=15 Participants
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).
|
Goal Directed Therapy
n=15 Participants
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.
|
|---|---|---|
|
Observation of Acute Respiratory Distress Syndrome (ARDS)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 30 days after lung surgeryTo compare hospital stay in both groups
Outcome measures
| Measure |
Standard Care
n=15 Participants
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).
|
Goal Directed Therapy
n=15 Participants
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.
|
|---|---|---|
|
Duration of Hospital Stay
|
4 days
Interval 4.0 to 5.0
|
5 days
Interval 4.0 to 6.0
|
SECONDARY outcome
Timeframe: Within 30 days after lung surgeryTo compare the mortality rate in both groups
Outcome measures
| Measure |
Standard Care
n=15 Participants
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).
|
Goal Directed Therapy
n=15 Participants
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.
|
|---|---|---|
|
Mortality
|
1 Participants
|
0 Participants
|
Adverse Events
Standard Care
Serious events: 3 serious events
Other events: 12 other events
Deaths: 1 deaths
Goal Directed Therapy
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Care
n=15 participants at risk
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).
|
Goal Directed Therapy
n=15 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute Pneumonia
|
13.3%
2/15 • Number of events 2 • 30 days
|
6.7%
1/15 • Number of events 1 • 30 days
|
|
Cardiac disorders
Thoracic Pain
|
6.7%
1/15 • Number of events 1 • 30 days
|
0.00%
0/15 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/15 • 30 days
|
6.7%
1/15 • Number of events 1 • 30 days
|
|
Cardiac disorders
Atrial Fibrillation Paroxysmal
|
6.7%
1/15 • Number of events 1 • 30 days
|
6.7%
1/15 • Number of events 1 • 30 days
|
|
Skin and subcutaneous tissue disorders
Severe Subcutaneous Emphysema
|
0.00%
0/15 • 30 days
|
6.7%
1/15 • Number of events 1 • 30 days
|
Other adverse events
| Measure |
Standard Care
n=15 participants at risk
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).
|
Goal Directed Therapy
n=15 participants at risk
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.
|
|---|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
20.0%
3/15 • Number of events 3 • 30 days
|
33.3%
5/15 • Number of events 5 • 30 days
|
|
Skin and subcutaneous tissue disorders
Exanthema
|
6.7%
1/15 • Number of events 1 • 30 days
|
0.00%
0/15 • 30 days
|
|
Gastrointestinal disorders
Postoperative Nausea and Vomiting
|
20.0%
3/15 • Number of events 3 • 30 days
|
26.7%
4/15 • Number of events 4 • 30 days
|
|
Skin and subcutaneous tissue disorders
Surgical Site Infection
|
6.7%
1/15 • Number of events 1 • 30 days
|
0.00%
0/15 • 30 days
|
|
Cardiac disorders
Arterial Hypotension
|
26.7%
4/15 • Number of events 4 • 30 days
|
60.0%
9/15 • Number of events 9 • 30 days
|
|
General disorders
Fever
|
6.7%
1/15 • Number of events 1 • 30 days
|
0.00%
0/15 • 30 days
|
|
Skin and subcutaneous tissue disorders
Mild-Moderate Subcutaneous Emphysema
|
0.00%
0/15 • 30 days
|
13.3%
2/15 • Number of events 2 • 30 days
|
Additional Information
Dr. Alejandro Domínguez-Blanco
Hospital Universitario Virgen del Rocío, Servicio Andaluz de Salud
Phone: 0034660762856
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place