Timing and Dose of Fluid Deresuscitation in Critically Ill Patients

NCT07275658 | Recruiting

• 1 other identifier: 2025.0391
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Fluid Overload; Critical Care, Intensive Care; Deresuscitation

Keywords

ultrasound, RRT, furosemide

Outcome Measures

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)

  24 hours

Secondary Outcomes (16)

• Successful deresuscitation

  24 hours

• Rate of deresuscitation

  24 hours

• Dose of deresuscitation

  24 hours

• Natriuresis

  24 hours

• Delta Strong Ion Difference

  24 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to the Intensive Care Unit

You may qualify if:

• 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.

You may not qualify if:

• Age below 18 years old;
• Major cardiac shunts;
• Moderate to severe aortic regurgitation;
• Morbid Obesisty (BMI \>40);
• POCUS impossible or unreliable (i.e. pre-existing interstitial lung disease);
• PLR or modified form of PLR impossible (i.e. ECMO);
• Transfer from another ICU;
• Patients who are moribund or facing the end of life;
• Opt out.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• OLVG: collaborator

Study Sites (2)

OLVG

Amsterdam, 1091AC, Netherlands

RECRUITING

Amsterdam UMC

Amsterdam, 1105AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Krijna Opschoor, MD

CONTACT

+31 (0)20 566 9111; k.opschoor@amsterdamumc.nl

Santje A.S. Slot, MD

CONTACT

s.a.s.slot@olvg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. P.R. Tuinman

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 10, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: January 21, 2026

Record last verified: 2025-11

Locations

NL (2)