Effectiveness of Vancomycin Loading Therapy

NCT01623817 | Completed DMC

• 1 other identifier: 2011-09-067
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of tish clinical research study is to identify that loading of vancomycin can facilitate rapid attainment of target trough serum vancomycin concentration.

Conditions

Infection

Outcome Measures

Primary Outcomes (1)

• Time duration for concentration of vancomycin to reach target trough of 15-20 mg/L

  Peak level drawn 1 hour after the completion of loading dose. Sequential trough level drawn 30 min before each standard dose for the next 4 doses.

Secondary Outcomes (1)

• Adverse event rate in each arm, including nephrotoxicity and rash.

  7 days post-treatment

Study Arms (2)

Vancomcyin, maintain dose

NO INTERVENTION

This arm is received only maintain dose of vancomycin (15mg/kg twice a day or 1g twice a day).

Vancomycin loading

EXPERIMENTAL

This group is received loading dose 30mg/kg. Subsequent doses of vancomycin are considered standard of care.

Drug: Vancomycin HCL

Interventions

Vancomycin HCL DRUG

Loading dose of 30mg/kg via central or peripheral intravenous infusion during 2 or 3 hours. Maintenance dose of vancomycin is 15mg/kg twice a day or 1g twice a day.

Also known as: The brand name is the Vancomycin hydrochloride., It is made by Lilly.

Vancomycin loading

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admission to Samsung Medical Center MICU and general wards for infectious diseases and hematology division
• Patients with SIRS (systemic inflammatory response syndrome)
• Intravenous vancomycin therapy deemed necessary

You may not qualify if:

• Age less than 20 years
• Age more than 75 years
• Current renal insufficiency defined as estimated Glomerular filtration rate \< 50mg/min/1.73 m2 by MDRD equation
• History of adverse events to vancomycin 5. Pregnant woman

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Infections

Interventions

Vancomycin

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Kyong Ran Peck, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2012
• First Posted: June 20, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 12, 2020

Record last verified: 2012-06

Locations

KR (1)