Assessment of Kidney Function for Drug Dosage Adjustments in Critically Ill Patients

NCT03045692 | Unknown

• 1 other identifier: 2016-12-147-003
• Study Type: interventional
• Target: 172
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to determine if colistin dosage adjustment using 4hr CrCl contribute to better clinical outcomes compared with drug dosage adjustment using eGFR in critical ill patients. In control group, colistin maintenance dosage will be decided using serum creatinine based eGFR (in ml/min). In study group, colistin maintenance dosage will be decided using 4hr CrCl.

Conditions

ICU Patients

Keywords

drug dosing, eGFR, CCr

Outcome Measures

Primary Outcomes (1)

• composite outcome (combination of nephrotoxicity or treatment failure)

  Nephrotoxicity means development of AKI (according to RIFLE criterior) Treatment failure menas clinically 'no response'

  7 days after colistin initiation

Secondary Outcomes (5)

• colistin trough level, renal clearance of colistin

  7 days after colistin initiation

• ICU stay duration

  till discharge (Max. 3 months)

• Total duration of colistin treatment

  till discharge (Max. 3 months)

• Need for renal replacement therapy

  7 days after colistin initiation

• In-ICU mortality (infection-attributed mortality)

  till discharge (Max. 3 months)

Study Arms (2)

Control group

ACTIVE COMPARATOR

creatinine based eGFR (which is not revised value with standardized body surface area, that is, 1.73m2) are used to decide colistin maintenance dosage.

Diagnostic Test: kidney function assessment by creatinine based eGFR

Study group

EXPERIMENTAL

4 hour creatinine clearance is used to decide colistin maintenance dosage.

Diagnostic Test: kidney function assessment by 4 hour creatinine clearance

Interventions

kidney function assessment by 4 hour creatinine clearance DIAGNOSTIC_TEST

4 hour creatinine clearance is used to decide colistin maintenance dosage.

Study group

kidney function assessment by creatinine based eGFR DIAGNOSTIC_TEST

creatinine based eGFR (which is not revised value with standardized body surface area, that is, 1.73m2) are used to decide colistin maintenance dosage.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged over 18
• Patients in intensive care unit received colistin for the microbiologically documented cases associated with carbapenem-resistant gram negative bacilli.

You may not qualify if:

• Patients who received colistin empirically.
• Patients who received renal replacement therapy due to acute kidney injury or end-stage renal disease
• Patients whose urine output was less than 0.5cc/kg/hr for 6 hrs
• Patients who underwent hematopoietic stem cell transplantation
• Patients who disagree with this study.

Sponsors & Collaborators

• Samsung Medical Center: lead

Central Study Contacts

Jung Eun Lee, MD,PhD

CONTACT

82-2-3410-6549; jungeun34.lee@samsung.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Double blind randomized trial

Study Record Dates

• First Submitted: February 5, 2017
• First Posted: February 7, 2017
• Study Start: February 13, 2017
• Primary Completion: February 28, 2019
• Study Completion: April 30, 2019
• Last Updated: February 8, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share