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

Not Applicable

Completed

• Conditions: Fluid Therapy; Goal Directed Therapy
• Interventions: Procedure: Standard care; Procedure: Goal directed therapy

• Registration Number: NCT03245372
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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

Study Timeline

• Study First Submitted: 2017-07-17
• Study First Submitted QC: 2017-08-07
• Study First Posted: 2017-08-10
• Study Start: 2017-10-10
• Primary Completion: 2018-03-23
• Study Completion: 2018-09-30
• Results First Submitted: 2021-06-07
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-19
• Last Update Submitted: 2021-10-19
• Results First Posted: 2021-10-20
• Last Update Posted: 2021-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care	Standard care	Basic intraoperative hemodynamic objectives
Goal directed therapy	Goal directed therapy	Target value is a cardiac index equal or superior to 2.2 l/min/m2.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Tissue Perfusion Marker: Lactate	Within 24 hours after lung surgery	To compare lactate 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
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
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
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
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
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

Trial Locations

Locations (1)

University hospital Virgen del Rocío; 🇪🇸 Sevilla, Spain