Timing and Dose of Fluid Deresuscitation in Critically Ill Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About this trial
Fluid deresuscitation is an important intervention in the Intensive Care Unit (ICU). This study aims to find (1) determinants of successful deresuscitation, (2) the optimal rate (dose) of deresuscitation based on these determinants, and (3) differences in metabolic profiles for a more personalized approach of deresuscitation.
This study is a multicenter, prospective, observational cohort study in critically ill patients. This study will include ICU patients who have a clinical indication for deresuscitation as set by the treating physician. Clinical, ultrasound and laboratory values will be collected and used for analysis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Admission to one of the participating ICUs;
Clinical indication for deresuscitation using diuretics or ultrafiltration as set by the treating physician; first attempt during the ICU stay.
Disqualifiers
Age below 18 years old;
Major cardiac shunts;
Moderate to severe aortic regurgitation;
Morbid Obesisty (BMI >40);
Trial population
Adult patients admitted to the Intensive Care Unit
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Successful deresuscitation without hemodynamic consequences
Reach negative fluid balance in first 24 hours without hemodynamic consequences (yes/no), defined as either hypotension or hypoperfusion: 1. Hypotension * Interventions required to maintain blood pressure MAP \> 65mmHg * Deresuscitation is stopped * Fluid bolus needs to be given * Noradrenaline (or other vasopressor) needs to be initiated, increased to \> 0.2 microg/kg/min, or increased by 50% * Dose reduction or interruption of RRT 2. Hypoperfusion (one of the following): * Arterial lactate level \>3 and/or increased 25% or more * New development of mottled skin * Capillary refill time \> 3 seconds * New oliguria (urine output \< 0.3-0.5ml/kg/hour for the previous 6 hours)
Time frame
24 hoursSecondary outcomes
1
Successful deresuscitation
Reach negative fluid balance in the first 24 hours
Time frame
24 hours2
Rate of deresuscitation
Urine output or ultrafiltration rate in mL/kg/h
Time frame
24 hours3
Dose of deresuscitation
Fluid balance in mL/kg
Time frame
24 hours4
Natriuresis
Urinary sodium output in mmol/L/24h
Time frame
24 hoursSponsors and contacts
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Source ClinicalTrials.gov