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

NCT03245372 | Completed Results

• 1 other identifier: 2017/118
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Conditions

Goal Directed Therapy; Fluid Therapy

Keywords

cardiac output; perioperative care; postoperative complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Tissue Perfusion Marker: Lactate

  Within 24 hours after lung surgery

• Tissue Perfusion Marker: SvcO2

  Within 24 hours after lung surgery

• Oxygenation Marker: PaO2/FiO2 Ratio

  Within 24 hours after lung surgery

• Fluid Balance

  After 24 hours of finalization of lung surgery

• Observation of Acute Kidney Injury (AKI)

  After 72 hours of finalization of lung surgery

Study Arms (2)

Standard care

ACTIVE COMPARATOR

Basic intraoperative hemodynamic objectives

Procedure: Standard care

Goal directed therapy

EXPERIMENTAL

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

Procedure: Goal directed therapy

Interventions

Standard care 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).

Also known as: Conventional fluid and hemodynamic management

Standard care

Goal directed therapy 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.

Also known as: Goal directed fluid and hemodynamic management

Goal directed therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults patients ( 18 years old)
• Written informed consent
• Elective lung resection surgery (open or thoracoscopic lung lobectomy)

You may not qualify if:

• Severe obesity
• Moderate to severe aortic insufficiency
• Renal failure requiring hemodialysis
• Left ventricle ejection fraction less than 35 %
• Urgent surgery

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (1)

University hospital Virgen del Rocío

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Postoperative Complications

Interventions

Standard of Care; Early Goal-Directed Therapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Critical Care; Patient Care; Therapeutics

Limitations and Caveats

This is a pilot study and the clinician (anesthesiologist) who performed the anesthetic procedure had to know the assignment of the arm. The intervention was limited to the intraoperative period. Postoperative morbidity and mortality surveillance was limited to one month. The study, therefore, was not designed to have sufficient power to detect significant differences in major postoperative complications.

Results Point of Contact

• Title: Dr. Alejandro Domínguez-Blanco
• Organization: Hospital Universitario Virgen del Rocío, Servicio Andaluz de Salud

aledguez@gmail.com

0034660762856

Study Officials

• Manuel Bertomeu, MD-PhD

  Andaluz Health Service

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: August 10, 2017
• Study Start: October 10, 2017
• Primary Completion: March 23, 2018
• Study Completion: September 30, 2018
• Last Updated: October 20, 2021
• Results First Posted: October 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 6 months after the completion of data analysis
• Access Criteria: colaborators in the investigation will be open to the whole data base and analysis performed

Locations

ES (1)