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Restrictive fluid management and early fluid de-escalation versus usual care In critically ill patients, A feasibility RCT study

Restrictive fluid management and early fluid de-escalation versus usual care In critically ill patients: A feasibility Randomized Controlled Trial.

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220719002
Enrollment
100
Registered
2022-07-19
Start date
2022-04-22
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically ill adult patients with circulatory shock requiring fluid resuscitation or vasopressors restrictive fluid management, circulatory shock, intensive care unit

Interventions

Daily fluid restriction to achieve zero balance. Fluid intake is restricted to drugs and nutrition. Reducing use of parenteral fluid and blood transfusion. Fluid bolus is given if clinically necessary
Fluid restrictive strategy,Usual care

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The patient who is 18 years of age or older 2. The patient with circulatory shock who need fluid resuscitation or vasopressor 3. The patient has been in intensive care unit for at least 12 hours but no more than 72 hours

Exclusion criteria

Exclusion criteria: 1. The patient with hypovolemic shock or hemorrhagic shock 2. The patient with active bleeding requiring blood transfusion 3. The patient who has severe AKI (KDIGO stage3) 4. The patient who is expected to initiate RRT within 24 hour 5. The patient who receives chronic RRT (maintenance dialysis or renal transplant) 6. The patient who needs maintenance fluid therapy (e.g. diabetic ketoacidosis, non-ketotic coma) 7. The patient with third space loss from severe ascites, severe burn, or bowel obstruction 8. Severe hyponatremia (Na <125mmol/L) or hypernatremia (Na >155mmol/L) 9. Congestive heart failure 10. Decompensated cirrhosis 11. Severe hypoalbuminemia (serum albumin < 2.0 g/dL) 12. The patient with ongoing gastrointestinal loss (e.g. persistent diarrhea) 13. The patient with ongoing fluid loss from drainage (more than 500 ml within 8 hours) 14. The patient with symptomatic fluid overload after fluid resuscitation 15. Pregnancy or lactation 16. Patient who receives palliative care 17. Furosemide allergy

Design outcomes

Primary

MeasureTime frame
fluid accumulation at 72 hours after enrollment volume of fluid (liter)

Secondary

MeasureTime frame
Major Adverse Kidney Event 30 days The composite of death, need of RRT, or doubling serum creatinine,All-cause mortality 30 days Reported outcome,Number of patients have AKI 3, 7, 30 dyas Reported outcome using laboratory data,Number of patients requiring RRT 3, 7, 30 days Reported outcome ,Vasopressor free days 30 days Reported outcome,Mechanical ventilator free days 30 days Reported outcome,Number of patients have fluid overload 3, 7 days Reported outcome,ICU length of stay within 3 months after enrollment Timeframe,Hospital length of stay within 6 months after enrollment Timeframe,ICU mortality within 3 months after enrollment Reported outcome,Hospital mortality within 6 months after enrollment Reported outcome

Countries

Thailand

Contacts

Public ContactUkrit Prajantasen

Faculty of Medicine Siriraj Hospital, Mahidol university

ukrit.pj@gmail.com0884441169

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026