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

NCT ID: NCT03755700

Last Updated: 2018-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Placebo

Normal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization combined with the placebos of both vitamin E and NAC (i.e. the placebo of vitamin E as a soft gel capsule and the placebo of NAC as an effervescent tablets along with a glass of water with the same consumption order used in the groups 2 and 3, respectively).

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

The placebo of vitamin E as a soft gel capsule with the consumption order similar to vitamin e group

Placebos

Intervention Type DRUG

The placebo of n-acetylcysteine as a tablet with the consumption order similar to n-acetylcysteine group

Normal Saline Flush, 0.9% Injectable Solution

Intervention Type DRUG

Normal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization

Vitamin E

Normal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization combined with vitamin E 800 IU orally 2 hours before intervention and 400 IU orally 4 hours after intervention plus the placebo of NAC with a consumption order similar to group 3.

Group Type ACTIVE_COMPARATOR

Vitamin E

Intervention Type DRUG

As a gel capsule of vitamin E 800 IU orally 2 hours before intervention and 400 IU orally 4 hours after intervention

Placebos

Intervention Type DRUG

The placebo of n-acetylcysteine as a tablet with the consumption order similar to n-acetylcysteine group

Normal Saline Flush, 0.9% Injectable Solution

Intervention Type DRUG

Normal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization

NAC

Normal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization combined with NAC 1200 mg orally 2 hours before intervention and 1200 mg orally 4 hours after intervention plus the placebo of vitamin E with the consumption order similar to group 2.

Group Type ACTIVE_COMPARATOR

N-acetyl cysteine

Intervention Type DRUG

As an effervescent tablets of NAC 1200 mg orally 2 hours before intervention and 1200 mg orally 4 hours after intervention

Placebo oral capsule

Intervention Type DRUG

The placebo of vitamin E as a soft gel capsule with the consumption order similar to vitamin e group

Normal Saline Flush, 0.9% Injectable Solution

Intervention Type DRUG

Normal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization

Interventions

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Vitamin E

As a gel capsule of vitamin E 800 IU orally 2 hours before intervention and 400 IU orally 4 hours after intervention

Intervention Type 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

Intervention Type DRUG

Placebo oral capsule

The placebo of vitamin E as a soft gel capsule with the consumption order similar to vitamin e group

Intervention Type DRUG

Placebos

The placebo of n-acetylcysteine as a tablet with the consumption order similar to n-acetylcysteine group

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

acute ST-segment elevation myocardial infarction, high-risk NSTE-ACS warranting emergency coronary angiography (\<2 hours), cardiogenic shock, pulmonary edema, overt heart failure and/or ejection fraction \<30%, ACS undergoing coronary angiography or angioplasty during the previous 5 days, sensitivity to contrast medium, recent administration of contrast medium for any reason, AKI, history of dialysis, pregnancy, newly prescribed angiotensin converting enzyme inhibitors or angiotensin receptor blockers, bleeding and/or coagulopathy diseases, and consumption of nephrotoxic drugs, vitamin E, vitamin C, or N-acetylcysteine (NAC) at least 48 hours before intervention.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rajaie Cardiovascular Medical and Research Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rajaie cardiovascular medical and research center

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Yousef Rezaei, MD

Role: CONTACT

Phone: +98 91 2623 1864

Email: [email protected]

Bahram Mohebbi, MD

Role: CONTACT

Phone: + 98 21 2392

Email: [email protected]

Facility Contacts

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Majid Maleki, MD

Role: primary

References

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Rezaei Y, Khademvatani K, Rahimi B, Khoshfetrat M, Arjmand N, Seyyed-Mohammadzad MH. Short-Term High-Dose Vitamin E to Prevent Contrast Medium-Induced Acute Kidney Injury in Patients With Chronic Kidney Disease Undergoing Elective Coronary Angiography: A Randomized Placebo-Controlled Trial. J Am Heart Assoc. 2016 Mar 15;5(3):e002919. doi: 10.1161/JAHA.115.002919.

Reference Type BACKGROUND
PMID: 27068631 (View on PubMed)

Rezaei Y, Hemila H. Vitamins E and C May Differ in Their Effect on Contrast-Induced Acute Kidney Injury. Am J Kidney Dis. 2017 May;69(5):708-709. doi: 10.1053/j.ajkd.2016.12.022. Epub 2017 Mar 6. No abstract available.

Reference Type BACKGROUND
PMID: 28279510 (View on PubMed)

Other Identifiers

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Intervention-01

Identifier Type: -

Identifier Source: org_study_id