Protective Effects of Oral L-Arginine CI-AKI

Phramongkutklao College of Medicine and Hospital

Status and phase: Unknown; Phase 4

Conditions: Contrast Induced AKI

Treatments: Dietary Supplement: L-arginine; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02455960

Arginine 01

Details and patient eligibility

About

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

Full 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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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112 participants in 2 patient groups, including a placebo group

Arginine

Experimental group

Description:

Participants need to take arginine 3 g/day orally for 3 days before CT with contrast media injection

Treatment:

Dietary Supplement: L-arginine

Placebo

Placebo Comparator group

Description:

Participants need to take placebo (corn powder) 3 g/day orally for 3 days before CT with contrast media injection

Treatment:

Dietary Supplement: Placebo