An observational study in Fluid Overload, Critical Care, Intensive Care and Deresuscitation, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Recruiting at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Observational
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.
Primary objective:
The aim of this study is to identify determinants of successful deresuscitation in ICU patients, defined as achieving a negative fluid balance within 24 hours without hemodynamic consequences.
Secondary objectives:
Timing of deresuscitation:
Rate (dose) of deresuscitation:
Possible complications of deresuscitation:
Study design:
The TIDE study is a multicenter, prospective, observational cohort study in the ICUs of the Amsterdam UMC and OLVG in Amsterdam, the Netherlands.
Study population:
Adult patients admitted to the ICU, who have a clinical indication for deresuscitation as set by the treating physician, using diuretics or ultrafiltration; first deresuscitation attempt during the ICU stay.
Sample size calculation:
For finding associations with logistic regression with a moderate (odds ratio >1.5) to strong (odds ratio >2.5) effect an alpha set at 0.05, power set at 0.8 and an estimated failure of 50% or more, we would need a sample size of around 150-210 patients.
Methods:
Patients in the participating ICUs are screened for eligibility when the treating physician sets a clinical indication for deresuscitation. Eligible patients will be included in the study. At that time, defined as baseline, clinical, ultrasound and laboratory measures will be collected. Clinical measures among others include: heart rate, mean arterial pressure, dose of vasopressors, and capillary refill time. Ultrasound measurements include: lung ultrasound scores (LUS), venous excess ultrasound (VExUS), and cardiac ultrasound, including VTI during a passive leg raise (PLR). Laboratory measurements include arterial blood gas analysis and urinalysis. Furthermore, baseline characteristics such as demographics, reason for ICU admission, severity of illness scores, and medical history are collected.
Deresuscitation will be performed according to standard care according to the treating physician's insights. Primary follow up is 24 hours in which granular data of deresuscitation tactics, deresuscitation output, electrolyte and acid-base disturbances, and hemodynamic consequences are collected. Secondary follow up is at 7 days for complications such as acute kidney injury and at 28 days for mortality, ICU length of stay (LOS) and ventilator free days (VFD), where available.
566 studies on the registry are indexed under Edema; 95 are open to participants now.
This study's planned enrollment of 150 is above the median of 67 across 143 observational studies indexed under Edema.
Browse Edema studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 532 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients admitted to the Intensive Care Unit
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 hours
Successful deresuscitation
Reach negative fluid balance in the first 24 hours
Time frame: 24 hours
Rate of deresuscitation
Urine output or ultrafiltration rate in mL/kg/h
Time frame: 24 hours
Dose of deresuscitation
Fluid balance in mL/kg
Time frame: 24 hours
Natriuresis
Urinary sodium output in mmol/L/24h
Time frame: 24 hours
Delta Strong Ion Difference
ΔSID in mmol/L
Time frame: 24 hours
Delta serum sodium
Serum ΔNa in mmol/L
Time frame: 24 hours
Delta serum chloride
Serum ΔCl in mmol/L
Time frame: 24 hours
Atrial fibrillation
Occurrence of ≥1 hour AF or AF for which treatment is needed during the deresuscitation window if not present at baseline
Time frame: 24 hours
Acute Kidney Injury (AKI)
AKI as diagnosed based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria: Stage 1: sCreat 1.5-1.9 times baseline OR ≥0.3 mg/dl (≥26.5 mmol/l) increase OR urine output \<0.5 ml/kg/h for 6-12 hours Stage 2: sCreat 2.0-2.9 times baseline OR urine output \<0.5 ml/kg/h for ≥12 hours Stage 3: sCreat 3.0 times baseline OR Increase in serum creatinine to ≥4.0 mg/dl (X353.6 mmol/l) OR Initiation of renal replacement therapy OR urine output \<0.3 ml/kg/h for ≥24 hours OR anuria for ≥ 12 hours
Time frame: 7 days
Persistent AKI
Prolonged AKI for ≥48 hours if not present before start deresuscitation
Time frame: 7 days
Renal Replacement Therapy (RRT)
Need for RRT after start deresuscitation if not used at baseline and primary deresuscitation
Time frame: 7 days
Delirium
Need 1 or more types of medication to treat delirium after start deresuscitation
Time frame: 7 days
ICU-mortality
Mortality within ICU stay
Time frame: 28 days
28-day mortality
Mortality after 28 days
Time frame: 28 days
Ventilator free days (VFD)
Patient is alive and breathes without assistance of the mechanical ventilator, if the period of unassisted breathing lasted at least 24 consecutive hours: * VFD-28 = 0 if subject dies within 28 days of mechanical ventilation * VFD-28 = 28 - x if successfully liberated from ventilation x days after initiation successful liberation: extubation (planned or unplanned) without death or reintubation within the next 72 hours * VFD-28 = 0 if the subject is mechanically ventilated for ≥ 28 days
Time frame: 28 days
ICU length of stay (LOS)
Length of stay in the intensive care unit
Time frame: 28 days
Started Oct 2025 (actual). Primary completion is estimated for Jan 2027, 15 months after the start.
Of 76 non-industry observational studies under Edema, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 39. This study's planned 15 months is below that.
Counting every sponsor, half of 85 studies reached it within 23 months; a quarter within 7 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) →