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

NCT ID: NCT03245372

Last Updated: 2021-10-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-10

Study Completion Date

2018-09-30

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

Conditions

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Goal Directed Therapy Fluid Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Standard care

Basic intraoperative hemodynamic objectives

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type PROCEDURE

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

Target value is a cardiac index equal or superior to 2.2 l/min/m2.

Group Type EXPERIMENTAL

Goal directed therapy

Intervention Type PROCEDURE

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.

Interventions

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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).

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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Conventional fluid and hemodynamic management Goal directed fluid and hemodynamic management

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manuel Bertomeu, MD-PhD

Role: STUDY_CHAIR

Andaluz Health Service

Locations

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University hospital Virgen del Rocío

Seville, , Spain

Site Status

Countries

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Spain

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2017/118

Identifier Type: -

Identifier Source: org_study_id