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

Phase 2

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

• Registration Number: TCTR20220719002
• Lead Sponsor: /A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-19
• Study Completion: 2023-03-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: nknown
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
fluid accumulation at 72 hours after enrollment volume of fluid (liter)

Secondary Outcome Measures

Name	Time	Method
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