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| Name | Class |
|---|---|
| OLVG | NETWORK |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Successful deresuscitation without hemodynamic consequences | Reach negative fluid balance in first 24 hours without hemodynamic consequences (yes/no), defined as either hypotension or hypoperfusion:
| 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Successful deresuscitation | Reach negative fluid balance in the first 24 hours | 24 hours |
| Rate of deresuscitation | Urine output or ultrafiltration rate in mL/kg/h |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients admitted to the Intensive Care Unit
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLVG | Recruiting | Amsterdam | 1091AC | Netherlands |
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| ID | Term |
|---|---|
| D004487 | Edema |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 24 hours |
| Dose of deresuscitation | Fluid balance in mL/kg | 24 hours |
| Natriuresis | Urinary sodium output in mmol/L/24h | 24 hours |
| Delta Strong Ion Difference | ΔSID in mmol/L | 24 hours |
| Delta serum sodium | Serum ΔNa in mmol/L | 24 hours |
| Delta serum chloride | Serum ΔCl in mmol/L | 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 | 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 | 7 days |
| Persistent AKI | Prolonged AKI for ≥48 hours if not present before start deresuscitation | 7 days |
| Renal Replacement Therapy (RRT) | Need for RRT after start deresuscitation if not used at baseline and primary deresuscitation | 7 days |
| Delirium | Need 1 or more types of medication to treat delirium after start deresuscitation | 7 days |
| ICU-mortality | Mortality within ICU stay | 28 days |
| 28-day mortality | Mortality after 28 days | 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:
| 28 days |
| ICU length of stay (LOS) | Length of stay in the intensive care unit | 28 days |
| Amsterdam UMC | Recruiting | Amsterdam | 1105AZ | Netherlands |
|