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Comparison of 250 ml Versus 500 ml of Fluid Challenge (KOBIAS)

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ClinicalTrials.gov Identifier: NCT03874923
Recruitment Status : Unknown
Verified March 2019 by Centre Hospitalier Universitaire, Amiens.
Recruitment status was:  Not yet recruiting
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
Centre Hospitalier Universitaire Dijon
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Study Description
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Brief Summary:
The objective of fluid challenge is to increase oxygen delivery (DO2) in order to improve/restore tissue oxygen consuption (VO2). However the fluid challenge volume to administer stills in debate, some studies recommend to administer 250 mL. Previous studies suggested that 500 mL of fluid challenge administration may improve cardiac output and oxygen delivery. The relation between the amount of fluid expansion and oxygen delivery and oxygen consumption was not yet been studied in a randomized study in critical care patients. This is the purpose of this study.

Condition or disease Intervention/treatment Phase
Fluid Challenge Oxygen Consumption Critical Care Other: Fluid challenge Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of 250 ml Versus 500 ml of Fluid Challenge on Oxygen Consumption in Critical Care Patients: an Open Label Multicentre Prospective Study
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 250 mL of fluid challenge Other: Fluid challenge
After randomisation, patient will receive 250 ml or 500 ml of fluid challenge. VO2 will be assessed before fluid challenge, immediately, 30 minutes and 60 minutes after fluid challenge.
Experimental: 500 mL of fluid challenge Other: Fluid challenge
After randomisation, patient will receive 250 ml or 500 ml of fluid challenge. VO2 will be assessed before fluid challenge, immediately, 30 minutes and 60 minutes after fluid challenge.


Outcome Measures
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Primary Outcome Measures :
  1. VO2 after fluid challenge [ Time Frame: 30 minutes after fluid challenge. ]
    Tissue oxygen consumption (VO2) after fluid challenge

  2. VO2 after fluid challenge [ Time Frame: 60 minutes after fluid challenge. ]
    Tissue oxygen consumption (VO2) after fluid challenge


Secondary Outcome Measures :
  1. Change of arterial lactate concentration from baseline [ Time Frame: 30 minutes after fluid challenge. ]
    Baseline is the measurement of arterial lactate concentration immediately after fluid challenge

  2. Change of arterial lactate concentration from baseline [ Time Frame: 60 minutes after fluid challenge. ]
    Baseline is the measurement of arterial lactate concentration immediately after fluid challenge

  3. Cardiac output [ Time Frame: Immediately, 30 and 60 minutes after fluid challenge. ]
    Cardiac output after fluid challenge.

  4. Respiratory variation of stroke volume [ Time Frame: Immediately, 30 and 60 minutes after fluid challenge. ]
    Respiratory variation of stroke volume after fluid challenge.

  5. PaO2/FiO2 [ Time Frame: Immediately, 30 and 60 minutes after fluid challenge. ]
    PaO2/FiO2 ratio (ratio of arterial oxygen partial pressure to fractional inspired oxygen) after fluid challenge

  6. Respiratory variation of the pulse pressure [ Time Frame: 30 and 60 minutes after fluid challenge. ]
    Respiratory variation of the pulse pressure

  7. Stroke volume variation with passive leg raising (PLV) [ Time Frame: 30 and 60 minutes after fluid challenge. ]
    Stroke volume variation with passive leg raising (PLV)

  8. Systolic heart function (LVEF) [ Time Frame: Immediately, 30 and 60 minutes after fluid challenge. ]
    Systolic heart function (LVEF)

  9. Diastolic heart function [ Time Frame: Immediately, 30 and 60 minutes after fluid challenge. ]
    Diastolic heart function (E, A, E', A', S' waves)


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:

  • Patient for whom the physician in charge decided to infuse fluid challenge because of signs of acute circulatory failure (systolic arterial blood pressure < 90mmHg, and/or mean arterial blood pressure< 65 mmHg, and/or the need of vasopressive amine infusion, and/or skin motling, and/or diuresis <0.5 mL/kg/h for more than 2 hours, and/or arterial lactate level>2mmol/L.
  • Echogenic patient
  • Patient with a Stroke Volume (SV) variation with passive leg raising (PLR) more than 10%.
  • Patient with regular sinus rythm.
  • Patient who received protocol information.

Exclusion Criteria:

  • Age Under 18-year-old.
  • Pregnancy.
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): NCT03874923


Contacts
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Contact: Osama Abou-Arab, Dr (33) 322087836 abouarab.osama@chu-amiens.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Centre Hospitalier Universitaire Dijon
Investigators
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Principal Investigator: Osama Abou-Arab, Dr CHU Amiens
More Information
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03874923    
Other Study ID Numbers: PI2018_843_0034
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
fluid expansion
oxygen delivery
tissue perfusion
cardiac output