Combined cystatin C and creatinine based estimated glomerular filtration rate for COListin Dosing on Prevention of Acute Kidney Injury: a randomized controlled trial

Phase 2

• Conditions: Patients receiving intravenous colistin; Colistin; Cystatin C; Acute kidney injury

• Registration Number: TCTR20240605006
• Lead Sponsor: Excellence Center for Critical Care Nephrology, Faculty of Medicine, Chulalongkorn University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-05
• Last Update Posted: 19 August 2024
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

1. Enrolled within 24 hours after the first dose of colistin and expected colistin duration >=48 hours)
2. At risk of low muscle mass defined by sarcopenia index <80%

Exclusion Criteria

1. AKI any stage by KDIGO criteria 2012
2. End stage kidney disease
3. History of kidney transplant
4. Pregnancy
5. Received any routes of colistin within 14 days prior to the day of enrollment
6. Expected death within 48 hours

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute kidney injury occurrence Day 14 Event

Secondary Outcome Measures

Name	Time	Method
Target colistin trough level (Ctrough) achievement Day 3 Colistin level,AKI maximal severity Day 14 KDIGO 2012 staging,Subclinical AKI Day 14 Urinary TIMP2*IGFBP7, Urinary NGAL,In-hospital death At discharge Event,Treatment failure At discharge Event,Recurrence of infection At discharge Event,Duration of colistin therapy At discharge Day,Hospital length of stay At discharge Day