Study of Obese Patients Comparing Two Vancomycin Loading Dose Regimens

Obesity Clinical Trial

Official title:

Single-Center Prospective Study of Obese Patients Comparing Two Vancomycin Loading Dose Regimens

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02764359
• Other study ID #: 15-120
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2016
• Est. completion date: January 22, 2021

Study information

• Verified date: February 2020
• Source: CAMC Health System
• Contact: William Payne, MD
• Phone: 304-388-6004
• Email: Murnau[@]aol.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: January 22, 2021
• Est. primary completion date: January 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Infection
• Obesity
• Sepsis

Intervention

Drug:
• IV vancomycin
IV vancomycin for the treatment of infection. Following the vancomycin loading dose, vancomycin dosing will be at the discretion of the pharmacist and attending physician and will follow standard of care.

Locations

Country	Name	City	State
United States	CAMC Health Systems	Charleston	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
CAMC Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to attain therapeutic vancomycin concentrations		< 7 days
Secondary	Reported adverse events	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.	48 hours post initial vancomycin dose
Secondary	Examine the pharmacokinetic parameter of elimination rate constant (ke) following the loading vancomycin dose		12 hours
Secondary	Examine the pharmacokinetic parameter of volume of distribution (Vd) following the loading vancomycin dose		12 hours
Secondary	Intensive care unit length of stay		30 days
Secondary	Hospital length of stay		30 days
Secondary	In-hospital mortality		30 days