Study of Obese Patients Comparing Two Vancomycin Loading Dose Regimens

Not Applicable

• Conditions: Sepsis; Obesity; Infection
• Interventions: Drug: IV vancomycin

• Registration Number: NCT02764359
• Lead Sponsor: CAMC Health System

Brief Summary

Obesity alters the movement through the body of several antibiotics, including vancomycin. Based on literature to date, total body weight should be used to determine dosages and shorter dosing intervals may be needed. However, hospitals have different approaches to managing vancomycin in this patient population. The most common example is not exceeding a dose of 2,000mg of vancomycin at one time in these patients. However, some institutions including the Charleston Area Medical Center do not have a set maximum one time dose. To date, a study has not been done comparing two different dosing regimens in obese patients to determine if having a maximum dose cap is beneficial.

This research study is attempting to add to the limited existing body of literature regarding vancomycin dosing in obese patients. The investigators hypothesize that optimizing the initial or loading vancomycin dose that obese patients receive will decrease the time to target concentrations. For this study, obese adult patients will be randomized to receive either 1) a loading dose of 20 mg/kg with a maximum dose up to 2,000mg OR 2) a loading dose of 20 mg/kg with a maximum dose of up to 4,000mg. The study's primary aim is to determine differences in the time needed to achieve target vancomycin concentrations and the occurrence of adverse events.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-02
• Study First Submitted QC: 2016-05-05
• Study First Posted: 2016-05-06
• Study Start: 2016-08-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-01
• Last Update Posted: 2020-02-05
• Primary Completion: 2021-01-22
• Study Completion: 2021-01-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• Patients ≥18 years of age who present to the Charleston Area Medical Center-Memorial Hospital Emergency Department
• Weight >100kg
• Infection requiring intravenous vancomycin and admission to Charleston Area Medical Center-Memorial Hospital

Exclusion Criteria

• Any patient <18 years of age
• Patients on dialysis or with unstable renal function (a change of >0.5 mg/dL in SCr concentration in patients with a SCr of <2 mg/dL or a 20% change in SCr in patients with a SCr of ≥2 mg/dL)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV Vancomycin loading dose- higher	IV vancomycin	IV Vancomycin loading dose: 20 mg/kg with a maximum dose of 4,000mg
IV Vancomycin loading dose- lower	IV vancomycin	IV Vancomycin loading dose: 20 mg/kg with a maximum dose of 2,000mg

Primary Outcome Measures

Name	Time	Method
Time to attain therapeutic vancomycin concentrations	< 7 days

Secondary Outcome Measures

Name	Time	Method
Hospital length of stay	30 days
Examine the pharmacokinetic parameter of volume of distribution (Vd) following the loading vancomycin dose	12 hours
Examine the pharmacokinetic parameter of elimination rate constant (ke) following the loading vancomycin dose	12 hours
Reported adverse events	48 hours post initial vancomycin dose	Red Man's syndrome: pruritus and erythematous rash involving the face, neck, and upper torso.; Nephrotoxicity: increase in serum creatinine (SCr) by 0.5 mg/dL or 50% from baseline on two consecutive measurements.
Intensive care unit length of stay	30 days
In-hospital mortality	30 days

Trial Locations

Locations (1)

CAMC Health Systems; 🇺🇸 Charleston, West Virginia, United States