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

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ClinicalTrials.gov Identifier: NCT03245372
Recruitment Status : Completed
First Posted : August 10, 2017
Results First Posted : October 20, 2021
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Study Description
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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

Condition or disease Intervention/treatment Phase
Goal Directed Therapy Fluid Therapy Procedure: Standard care Procedure: Goal directed therapy Not Applicable

Detailed 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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Goal Directed Therapy Versus Standard Care in Lung Resection Surgery, a Randomized, Controlled Trial (GDT-thorax Study).
Actual Study Start Date : October 10, 2017
Actual Primary Completion Date : March 23, 2018
Actual Study Completion Date : September 30, 2018
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard care
Basic intraoperative hemodynamic objectives
 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).
Other Name: Conventional fluid and hemodynamic management
Experimental: Goal directed therapy
Target value is a cardiac index equal or superior to 2.2 l/min/m2.
 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.
Other Name: Goal directed fluid and hemodynamic management


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03245372


Locations
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Spain
University hospital Virgen del Rocío
Sevilla, Spain, 41013
Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Investigators
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Study Chair: Manuel Bertomeu, MD-PhD Andaluz Health Service
  Study Documents (Full-Text)

Documents provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
Study Protocol and Statistical Analysis Plan  [PDF] March 29, 2017

More Information
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Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT03245372    
Other Study ID Numbers: 2017/118
First Posted: August 10, 2017    Key Record Dates
Results First Posted: October 20, 2021
Last Update Posted: October 20, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Yes. Anonymized data for individual patient data is planned to be shared with all participants within 6 months of data completion
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
cardiac output
perioperative care
postoperative complications