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

Fluid Therapy Clinical Trial

— GDT-thorax  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03245372
• Other study ID #: 2017/118
• Status: Completed
• Phase: N/A
• Start date: October 10, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: October 2021
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 30, 2018
• Est. primary completion date: March 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fluid Therapy
• Goal Directed Therapy

Intervention

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).
• 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.

Locations

Country	Name	City	State
Spain	University hospital Virgen del Rocío	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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	Tissue Perfusion Marker: Lactate	To compare lactate in the first 24 hours in both groups	Within 24 hours after lung surgery
Secondary	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
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	Within 24 hours after lung surgery
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	After 24 hours of finalization of lung surgery
Secondary	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
Secondary	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
Secondary	Duration of Hospital Stay	To compare hospital stay in both groups	Within 30 days after lung surgery
Secondary	Mortality	To compare the mortality rate in both groups	Within 30 days after lung surgery