NCT03755700

Vitamin E and N-acetylcysteine for Preventing Contrast-Induced Acute Kidney Injury After Coronary Artery Catheterization

Antioxidants for Preventing Contrast-Induced Acute Kidney Injury After Coronary Artery Catheterization

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Rajaie Cardiovascular Medical and Research Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In a double-blinded randomized clinical trial, all patients undergoing coronary artery catheterization who will met our criteria, will be enrolled into three groups to receive either, vitamin e, n-acetylcysteine, or placebo. The aim of study will be to compare the superiority of vitamin e over n-acetylcysteine for the prevention of contrast-induced acute kidney injury (CIAKI).

Detailed description

Patients aged ≥18 years with chronic kidney disease who undergo coronary catheterization will be enrolled into the study if they meet the inclusion criteria. Patients will be randomly assigned into three groups in a 1:1:1 ratio (Computer-generated random number will be used to assign a patient in either group): we will use simple randomization for assigning each patient in a group. The participants, physicians and outcome assessors will be blinded throughout the trial until the opening of the randomization cold. All patients will be entered into three group and they will be given normal saline 0.9%, vitamin E, NAC, and the placebos of both regimens. The vitamin E will be given as a soft gel capsule and its placebo will have the same shape and taste. The NAC will be given as an effervescent tablet with a glass of water for consumption and its placebo will also have the same shape and taste. These drugs will be given in addition to the routine hydration therapy which will be given to all patients. Primary outcome will be the development of CIAKI. Secondary outcomes will be the development of major adverse cardiovascular events and any events till evaluating the CIAKI within 48-72 hours after intervention.

Conditions

• Coronary Artery Disease
• Coronary Artery Angiography
• Coronary Catheterization
• Contrast-induced Nephropathy
• Stable Angina
• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	Vitamin E	As a gel capsule of vitamin E 800 IU orally 2 hours before intervention and 400 IU orally 4 hours after intervention
DRUG	N-acetyl cysteine	As an effervescent tablets of NAC 1200 mg orally 2 hours before intervention and 1200 mg orally 4 hours after intervention
DRUG	Placebo oral capsule	The placebo of vitamin E as a soft gel capsule with the consumption order similar to vitamin e group
DRUG	Placebos	The placebo of n-acetylcysteine as a tablet with the consumption order similar to n-acetylcysteine group
DRUG	Normal Saline Flush, 0.9% Injectable Solution	Normal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization

Timeline

• Start date: 2018-11-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2018-11-28
• Last updated: 2018-11-30

Locations

1 site across 1 country: Iran