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

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla31 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Goal Directed Therapy Fluid Therapy

Interventions

Standard carePROCEDURE

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 therapyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University hospital Virgen del Rocío

Seville, Spain

Outcomes

Primary Outcomes

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.

Time frame: 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 Outcomes

Tissue Perfusion Marker: Lactate

To compare lactate in the first 24 hours in both groups

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: After 72 hours of finalization of lung surgery

Observation of Acute Respiratory Distress Syndrome (ARDS)

Data from ClinicalTrials.gov

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