Goal Directed Therapy Versus Standard Care in Lung Resection Surgery (GDT-thorax Study).

Study Overview
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Brief Summary
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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
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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

Official Title
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Goal Directed Therapy Versus Standard Care in Lung Resection Surgery, a Randomized, Controlled Trial (GDT-thorax Study).

Conditions
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Goal Directed Therapy, Fluid Therapy

Intervention / Treatment
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* Procedure: Standard care
* Procedure: Goal directed therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard care<br>Basic intraoperative hemodynamic objectives | Procedure: Standard care<br>* 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).<br>* Other names: Conventional fluid and hemodynamic management;|
| Experimental: Goal directed therapy<br>Target value is a cardiac index equal or superior to 2.2 l/min/m2. | Procedure: Goal directed therapy<br>* 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.<br>* Other names: Goal directed fluid and hemodynamic management;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue Perfusion Marker: Lactate | To compare lactate in the first 24 hours in both groups | Within 24 hours after lung surgery | 
| Tissue Perfusion Marker: SvcO2 | To compare SvcO2 (central venous oxygen saturation) in the first 24 hours in both groups | Within 24 hours after lung surgery | 
| 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 | Within 24 hours after lung surgery | 
| 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 | After 24 hours of finalization of lung surgery | 
| Observation of Acute Kidney Injury (AKI) | To compare the Number of Participants with Acute Kidney Injury in both groups | After 72 hours of finalization of lung surgery | 
| Observation of Acute Respiratory Distress Syndrome (ARDS) | To compare the he Number of Participants with Acute Respiratory Distress Syndrome in both groups | Within 30 days after lung surgery | 
| Duration of Hospital Stay | To compare hospital stay in both groups | Within 30 days after lung surgery | 
| Mortality | To compare the mortality rate in both groups | Within 30 days after lung surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac output, perioperative care, postoperative complications