Protective Effects of Oral L-Arginine CI-AKI

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

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

Study Overview

• Status: Unknown
• Conditions: Contrast Induced AKI
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: L-arginine

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 Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Rachatevee, Bangkok, Thailand, 10400
      • Recruiting
      • Division of Nephrology, Phramongkutklao Hospital
      • Contact: Nuttawut Siritaweesuk, MD.; Phone Number: 66819019191; Email: znak.iiz@gmaill.com
      • Principal Investigator: Nuttawut Siritaweesuk, MD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arginine; Participants need to take arginine 3 g/day orally for 3 days before CT with contrast media injection	Dietary supplement: L-arginine; Comparison of the efficacy of L-arginine 3 grams for days versus placebo in contrast induced AKI prevention
Placebo Comparator: Placebo; Participants need to take placebo (corn powder) 3 g/day orally for 3 days before CT with contrast media injection	Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Contrast-induced acute kidney injury (CI-AKI)	48 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Adverse effects	48 hours

Collaborators and Investigators

• Sponsor: Phramongkutklao College of Medicine and Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): April 1, 2016
• Study Completion (Anticipated): May 1, 2016

Study Registration Dates

• First Submitted: May 25, 2015
• First Submitted That Met QC Criteria: May 27, 2015
• First Posted (Estimate): May 28, 2015

Study Record Updates

• Last Update Posted (Estimate): May 28, 2015
• Last Update Submitted That Met QC Criteria: May 27, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: Arginine 01