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
|Condition or disease||Intervention/treatment||Phase|
|Septic Shock||Other: Minifluid challenge Other: Usual practice||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||684 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||stepped wedge cluster randomized trial|
|Masking:||Double (Participant, Investigator)|
|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|
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.
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.
- 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
- ICU length of stay until ability to ICU discharge [ Time Frame: 90 days ]
- Length of stay in hospital [ Time Frame: 90 days ]
- Ventilator free days at day 28 [ Time Frame: 28 days ]
- Renal failure free days at day 28 [ Time Frame: 28 days ]
- Catecholamine free days at day 10 [ Time Frame: 10 days ]
- Mortality at day 28 [ Time Frame: 28 days ]
- Mortality at day 90 [ Time Frame: 90 days ]
- 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:
- Physical functioning
- Bodily pain
- General health perceptions
- Physical role functioning
- Emotional role functioning
- Social role functioning
- Mental health
- 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
- PCL-5 [ Time Frame: 6 months ]Quality of life with PCL-5 questionnaire
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
|Contact: Olivier Huet, MD, PhDemail@example.com|