Protective Effects of Oral L-Arginine CI-AKI

Contrast Induced AKI Clinical Trial

Official title:

Protective Effects of Oral L-Arginine Supplement in Patients With CKD After Intravenous Contrast Media Injection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02455960
• Other study ID #: Arginine 01
• Status: Recruiting
• Phase: Phase 4
• First received: May 25, 2015
• Last updated: May 27, 2015
• Start date: September 2014
• Est. completion date: May 2016

Study information

• Verified date: May 2015
• Source: Phramongkutklao College of Medicine and Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board Royal Thai Army Medical Department
• Study type: Interventional

Clinical Trial Summary

This trial was performed to examine the efficacy of oral L-arginine for preventing CI-AKI in chronic kidney disease (CKD) patients.

Description:

Contrast-induced acute kidney injury (CI-AKI) is a common complication in hospitalized patients. Nitric oxide-signal transduction plays an important role in prevention of CI-AKI. L-Arginine is an amino acid involved in ammonia detoxification, and is well known as a precursor to nitric oxide, a key component of endothelial-derived relaxing factor.

This is a prospective randomized, double blind, placebo controlled trial among CKD stage 3-4 patients undergoing computer tomography. Eligible patients were randomly assigned to two groups: (1) arginine 3 g/day or 6 capsules per day, and (2) placebo 6 capsules per day for 3 days before contrast media injection. Serum cystatin C, serum creatinine and estimated GFR was measured at baseline and 48 hours after procedure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Stable CKD stage 3-4 patients

• Patients undergoing elective contrast media injection

Exclusion Criteria:

• History of arginine allergy

• Acute kidney injury diagnosed within 4 weeks

• Active infection/sepsis

• Severe liver disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contrast Induced AKI

Intervention

Dietary Supplement:
• L-arginine
Comparison of the efficacy of L-arginine 3 grams for days versus placebo in contrast induced AKI prevention
• Placebo

Locations

Country	Name	City	State
Thailand	Division of Nephrology, Phramongkutklao Hospital	Rachatevee	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Phramongkutklao College of Medicine and Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Contrast-induced acute kidney injury (CI-AKI)		48 hours	Yes
Secondary	Number of Adverse effects		48 hours	Yes