Clinical trial

Impact of Cystatin-C C-guided Vancomycin Dosing Recommendation on Target Trough Achievement and Clinical Outcomes in Critically Ill Adults

Name

14-002808

Description

Determine if a cystatin C-inclusive vancomycin dosing algorithm improved target trough achievement compared to creatinine clearance-guided vancomycin therapy in critically ill patients.

Trial arms

Trial start

2014-04-01

Estimated PCD

2015-06-01

Trial end

2016-03-01

Status

Completed

Phase

Early phase I

Treatment

Vancomycin

Intravenous

Arms:

Creatinine clearance guided vancomycin dosing, Cystatin C-guided vancomycin dosing algorithm

Other names:

Vancocin

Cystatin C dosing algorithm

Expressed in milliliters per minute

Arms:

Cystatin C-guided vancomycin dosing algorithm

Creatine clearance dosing algorithm

Vancomycin dosing algorithm based on creatinine clearance, expressed in milliliters per minute

Arms:

Creatinine clearance guided vancomycin dosing

Other names:

Cockcroft-Gault

Size

399

Primary endpoint

Vancomycin target trough achievement

Baseline

Eligibility criteria

Inclusion Criteria: * Hospitalized in one of three intensive care units at Mayo Clinic in Rochester, Minnesota * Suspected or documented gram-positive infection * Prescribed IV vancomycin at a consistent dose and scheduled with 8, 12, or 24 hour Vancomycin dosing interval Exclusion Criteria: * Vulnerable population * Received greater than 1 dose of Vancomycin in the 96 hours before ICU admission * Baseline glomerular filtration rate (GFR) of less than 20 milliliters/minute * Undergoing renal replacement therapy * Body mass index \> 40kg/m2 * Weight \< 40kg

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 399, 'type': 'ACTUAL'}}

Updated at

2023-10-10

1 organization

1 product

3 indications

Organization

Product

Indication

Indication

Indication