Protective Effects of Oral L-Arginine CI-AKI

Phase 4

• Conditions: Contrast Induced AKI
• Interventions: Dietary Supplement: L-arginine; Dietary Supplement: Placebo

• Registration Number: NCT02455960
• Lead Sponsor: Phramongkutklao College of Medicine and Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2014-09
• Status Verified: 2015-05
• Study First Submitted: 2015-05-25
• Study First Submitted QC: 2015-05-27
• Last Update Submitted: 2015-05-27
• Study First Posted: 2015-05-28
• Last Update Posted: 2015-05-28
• Primary Completion: 2016-04
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arginine	L-arginine	Participants need to take arginine 3 g/day orally for 3 days before CT with contrast media injection
Placebo	Placebo	Participants need to take placebo (corn powder) 3 g/day orally for 3 days before CT with contrast media injection

Primary Outcome Measures

Name	Time	Method
Incidence of Contrast-induced acute kidney injury (CI-AKI)	48 hours

Secondary Outcome Measures

Name	Time	Method
Number of Adverse effects	48 hours

Trial Locations

Locations (1)

Division of Nephrology, Phramongkutklao Hospital; 🇹🇭 Rachatevee, Bangkok, Thailand