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Guided Fluid-balance Optimization With Mini-fluid chALlenge During Septic Shock (GOAL)

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ClinicalTrials.gov Identifier: NCT03461900
Recruitment Status : Recruiting
First Posted : March 12, 2018
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:
Many observational studies have highlighted an independent association between fluid overload and clinical outcomes during septic shock. To optimize fluid balance, clinician has several options to consider carefully fluid administration and avoid fluid overload. More than a general restrictive approach, a pragmatic, individual tailored approach should be considered to optimize patients' hemodynamics during acute circulatory failure. Many advances in hemodynamic monitoring were described. Mini-fluid challenge appears to be a sensible method to use for bedside assessment to optimize fluid infusion. The next step for hemodynamic management in the ICU should be to test a hemodynamic goal-directed approach to better control fluid management and eventually improve patient's outcome. The main objective of the GOAL study is to evaluate a pragmatic optimization fluid management protocol tailored to each patient's hemodynamic status based on mini-fluid challenges. This intervention will be compared to usual management based on the latest guidelines. This intervention aims to decrease organ dysfunction during septic shock. This is the first large clinical trial designed to test this hypothesis.

Condition or disease Intervention/treatment Phase
Septic Shock Other: Minifluid challenge Other: Usual practice Not Applicable

Detailed Description:

GOAL study is a stepped wedge cluster-randomized trial. Centers will switch randomly from the control to the intervention at regular intervals:

  • Control periods: Patients receive a usual optimization fluid management according to surviving sepsis campaign guidelines.
  • Interventional periods: Patients receive a pragmatic, protocolized and individual optimization fluid management according to validated components of a hemodynamic challenges called Mini-Fluid Challenge (MFC).

Except fluid therapy in interventional group, management of sepsis will be at the discretion of the attending physician. The use of international guidelines for all therapeutic interventions is recommended in all patients whenever their group.

All patients will be followed from enrolment to death or hospital discharge. If alive but not in the hospital after 28 days since septic shock, clinical outcomes will be evaluated by a visit with an intensivist or, if a physical examination is not possible, by a telephone interview performed by an intensivist. To ensure the same data collection in all centers, visits were planned: D0 (inclusion), D1 to D10 (in ICUs), D28 and D180.

Classical blinded methods cannot be used in case of evaluation of an optimization protocol. Investigators are unblinded to which arm patient is randomized. To ensure the same evaluation for all patients and in all centers, all events recorded will be evaluated by an independent clinical event committee.

All primary endpoints will be analyzed according to a hierarchized analysis to ensure comparison of multiple issues without considering type I error inflation. Secondary outcomes will be analyzed as exploratory analysis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 684 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: stepped wedge cluster randomized trial
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Guided Fluid-balance Optimization With Mini-fluid chALlenge During Septic Shock: A Multicenter, Stepped Wedge Cluster Randomized Trial
Actual Study Start Date : June 4, 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: Minifluid challenge
100 ml of 4% Albumin will be deliver to assess fluid responsiveness
Other: Minifluid challenge
Pragmatic optimization fluid management protocol based on Mini-Fluid Challenge (MFC) in treating an acute circulatory failure. MFC consist of an infusion of 100 ml of colloid solution (4% human serum albumin) during 1 minute via a separate venous line. Before and after each MFC and depending on the hemodynamic device used, the attending physician will perform a first set of hemodynamic measurements, including cardiac index (CI) or cardiac output (CO); stroke volume (SV), indexed stroke volume (iSV) or velocity time index (VTI). If the variation in measurement is superior to 10%, the attending physician will infuse 400 ml of buffered crystalloid solution or saline solution. After an infusion of 500 ml, fluid responsiveness will be evaluated with CI or CO measurement. For non-responders, fluid challenge must be stopped and other therapeutics should be considered. For responder, another MFC should be consider if hemodynamic status is not stabilized.

Experimental: Control
Patient will be treated as defined by most recent surviving sepsis campaign guidelines
Other: Usual practice
Patients included in control group will be managed according to the last surviving sepsis recommendations edited in 2017.




Primary Outcome Measures :
  1. Delta SOFA score (Day0 - Day5) [ Time Frame: Day 5 ]

    Delta SOFA score is the difference between SOFA (Sepsis-related Organ Failure Assessment) measured at day 0 and at Day 5. SOFA score was developed to quantify organ dysfunction in patients with sepsis and to determine treatment effectiveness. SOFA score is a scale range from 0 to 24, with higher scores indicating worse organ dysfunction. Five organs dysfunctions are analyzed:

    • Respiratory: PaO2/FiO2 ratio
    • Cardio-vascular: severity of hypotension and need of vasopressors (µ/kg/min)
    • Renal: creatinine (mg/dl)
    • Hemostasis: Platelet count (G/l)
    • Liver: Bilirubin (mg/dl)
    • Neurologic: Glasgow coma scale

  2. ICU length of stay until ability to ICU discharge [ Time Frame: 90 days ]
  3. Length of stay in hospital [ Time Frame: 90 days ]
  4. Ventilator free days at day 28 [ Time Frame: 28 days ]
  5. Renal failure free days at day 28 [ Time Frame: 28 days ]
  6. Catecholamine free days at day 10 [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. Mortality at day 28 [ Time Frame: 28 days ]
  2. Mortality at day 90 [ Time Frame: 90 days ]

Other Outcome Measures:
  1. SF-36 (Short-Form 36) [ Time Frame: 6 months ]

    The SF-36 is an indicator of health status and quality of life. The SF-36 has eight dimensions; the scores are weighted sums of the questions in each section. This scores range from 0 - 100. Lower scores indicate more disability and higher scores less disability.

    The eight dimensions of this score are:

    • Vitality
    • Physical functioning
    • Bodily pain
    • General health perceptions
    • Physical role functioning
    • Emotional role functioning
    • Social role functioning
    • Mental health

  2. CANTAB test (Cambridge Neuropsychological Test Automated Battery) [ Time Frame: 6 months ]
    CANTAB test have demonstrated sensitivity to detecting changes in neuropsychological performance and include tests of working memory, learning and executive function; visual, verbal and episodic memory; attention, information processing and reaction time; social and emotion recognition, decision making and response control

  3. PCL-5 [ Time Frame: 6 months ]
    Quality of life with PCL-5 questionnaire



Information from the National Library of Medicine

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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:

  • Adult patient (Age > 18 years)
  • Admitted in ICU for less than 3 days.
  • Abdominal (excepted urinary tract infection) or pulmonary related septic shock, defined by SEPSIS III criteria diagnosed within less than 12 hours.
  • Written consent or oral by the patient (and/or consent signed by the next of skin)
  • Patient has social security affiliation or who beneficiary of such social security

Exclusion Criteria:

  • Patient with life expectancy inferior to 24 hours at the time of inclusion.
  • Cardiac arrest
  • Allergy to albumin
  • Pregnancy
  • Traumatic brain injury
  • Limitation of invasive therapeutics, palliative care
  • Patient under guardianship or curatorship

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): NCT03461900


Contacts
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Contact: Olivier Huet, MD, PhD +33298347449 olivier.huet@chu-brest.fr

Locations
Show Show 18 study locations
Sponsors and Collaborators
University Hospital, Brest
Publications:
Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03461900    
Other Study ID Numbers: 29BRC18.0054 (GOAL)
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication
Supporting Materials: Study Protocol
Time Frame: All collected data that underlie results in a publication
Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

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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 University Hospital, Brest:
Septic shock
Fluid optimisation
Minifluid challenge
Fluid overload
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation