Reducing Nephrotoxicity of Vancomycin: A Prospective Study of Continuous Versus Intermittent Infusion of Vancomycin

Reducing Nephrotoxicity of Vancomycin: A Prospective, Randomized Study of Continuous Versus Intermittent Infusion of Vancomycin

This study is being carried out to find out whether there is reduction in vancomycin-induced kidney injury (nephrotoxicity) when vancomycin is given as intermittent versus continuous infusion.

This study will recruit 220 subjects from 2 hospitals over a period of 3 years.

Participants are invited if they have an infection that requires prolonged vancomycin therapy (> more than 10 days).

Study Overview

• Status: Unknown
• Conditions: Infections Requiring Prolonged Duration (>10 Days) of Vancomycin
• Intervention / Treatment: Drug: continuous vancomycin infusion; Drug: intermittent vancomycin infusion

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shire Yang Tan; Phone Number: 97989001; Email: shire_yang_tan@nuhs.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • National University Hospital
    • Contact: Shire Yang Tan; Phone Number: 97989001; Email: shire_yang_tan@nuhs.edu.sg
    • Principal Investigator: Dale Fisher

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults aged 21-80 years
• Documented infection requiring prolonged (> 10 days) of vancomycin therapy
• Creatinine clearance > 50 ml/min (using Cockroft-Gault equation)

Exclusion Criteria:

• Patient already received 7 days or more of vancomycin therapy
• Pregnancy
• Severe burns > 40% body surface area
• Spinal cord injuries
• Participation in another interventional trial in previous 30 days
• Inability to obtain informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: continuous vancomycin infusion	Drug: continuous vancomycin infusion; 24-hour continuous infusion of vancomycin
ACTIVE_COMPARATOR: intermittent vancomycin infusion; vancomycin in this arm will be administered as intermittent infusion	Drug: intermittent vancomycin infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nephrotoxicity	nephrotoxicity as defined by the acute kidney injury network (AKIN) criteria using only serum creatinine criteria	occurring any time while on vancomycin treatment up to 14 days post treatment completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
biomarkers for detection of early nephrotoxicity	serum and urine NGAL and cystatin C	measured weekly from the date of randomization until 14 days post completion of vancomycin

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore
• Collaborators: Tan Tock Seng Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ANTICIPATED): September 1, 2015
• Study Completion (ANTICIPATED): September 1, 2015

Study Registration Dates

• First Submitted: October 21, 2012
• First Submitted That Met QC Criteria: November 1, 2012
• First Posted (ESTIMATE): November 2, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 2, 2012
• Last Update Submitted That Met QC Criteria: November 1, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin
• Other Study ID Numbers: NUHID-001