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

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

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

Study Overview

• Status: Completed
• Conditions: Fluid Therapy; Goal Directed Therapy
• Intervention / Treatment: Procedure: Standard care; Procedure: Goal directed therapy

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Sevilla, Spain, 41013
    • University Hospital Virgen del Rocio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Investigators: Study Chair: Manuel Bertomeu, MD-PhD, Andaluz Health Service

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2017
• Primary Completion (Actual): March 23, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: August 7, 2017
• First Posted (Actual): August 10, 2017

Study Record Updates

• Last Update Posted (Actual): October 20, 2021
• Last Update Submitted That Met QC Criteria: October 19, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: perioperative care; cardiac output; postoperative complications
• Other Study ID Numbers: 2017/118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Yes. Anonymized data for individual patient data is planned to be shared with all participants within 6 months of data completion
• IPD Sharing Time Frame: 6 months after the completion of data analysis
• IPD Sharing Access Criteria: colaborators in the investigation will be open to the whole data base and analysis performed
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes