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Completed

NCT Number: NCT03245372

Goal Directed Therapy Versus Standard Care in Lung Resection Surgery (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

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Key information

Conditions

Goal Directed Therapy Fluid Therapy Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital Virgen del Rocío

Seville, 41013, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: Conventional fluid and hemodynamic management

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.

Other names: Goal directed fluid and hemodynamic management

Primary outcomes

  1. 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.

    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.

Secondary outcomes

  1. Tissue Perfusion Marker: Lactate

    Time frame: Within 24 hours after lung surgery

    To compare lactate in the first 24 hours in both groups

  2. Tissue Perfusion Marker: SvcO2

    Time frame: Within 24 hours after lung surgery

    To compare SvcO2 (central venous oxygen saturation) in the first 24 hours in both groups

  3. Oxygenation Marker: PaO2/FiO2 Ratio

    Time frame: Within 24 hours after lung surgery

    To compare PaO2/FiO2 ratio (ratio of arterial oxygen partial pressure to fractional inspired oxygen) in the first 24 hours in both groups

  4. Fluid Balance

    Time frame: After 24 hours of finalization of lung surgery

    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

  5. Observation of Acute Kidney Injury (AKI)

    Time frame: After 72 hours of finalization of lung surgery

    To compare the Number of Participants with Acute Kidney Injury in both groups

  6. Observation of Acute Respiratory Distress Syndrome (ARDS)

    Time frame: Within 30 days after lung surgery

    To compare the he Number of Participants with Acute Respiratory Distress Syndrome in both groups

  7. Duration of Hospital Stay

    Time frame: Within 30 days after lung surgery

    To compare hospital stay in both groups

  8. Mortality

    Time frame: Within 30 days after lung surgery

    To compare the mortality rate in both groups

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

Registry information

Official study title

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

Acronym: GDT-thorax

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 10, 2017
Registry last updated
Oct 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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