Vitamin E and N-acetylcysteine for Preventing Contrast-Induced Acute Kidney Injury After Coronary Artery Catheterization
- Conditions
- Contrast-induced NephropathyCoronary Artery AngiographyStable AnginaCoronary CatheterizationCoronary Artery DiseaseAcute Coronary Syndrome
- Interventions
- Drug: Placebo oral capsuleDrug: PlacebosDrug: Normal Saline Flush, 0.9% Injectable Solution
- Registration Number
- NCT03755700
- Lead Sponsor
- Rajaie Cardiovascular Medical and Research Center
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
Patients aged ≥18 years with baseline estimated glomerular filtration rate (eGFR) <60 mL/min per 1.73 m2 (based on the Modification of Diet in Renal Disease study group formula) who undergo coronary catheterization (i.e. coronary angiography and percutaneous coronary intervention [PCI]) will be invited to the study if they meet the inclusion criteria: stable angina with ischemia and indication for coronary angiography, non-ST-segment elevation (NSTE) acute coronary syndrome (ACS) requiring an early invasive strategy, and patients undergoing elective PCI .
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vitamin E 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. NAC N-acetyl cysteine 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. Placebo Placebo oral capsule 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). Placebo Normal Saline Flush, 0.9% Injectable Solution 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). Vitamin E Placebos 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. Vitamin E Normal Saline Flush, 0.9% Injectable Solution 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. NAC Normal Saline Flush, 0.9% Injectable Solution 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. Placebo Placebos 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). NAC Placebo oral capsule 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.
- Primary Outcome Measures
Name Time Method Contrast-induced acute kidney injury 48 to 72 hours after coronary catheterization Contrast-induced acute kidney injury defined as an absolute increase ≥0.5 mg/dL or a relative increase ≥25% over baseline serum creatinine concentration within 48-72 hours after administration of contrast media.
- Secondary Outcome Measures
Name Time Method Requirement for renal replacement therapies 48-72 hours post-procedure Requirement for renal replacement therapies, ie, any kind of dialysis or renal transplantation
Changes in the levels of serum creatinine 48-72 hours post-procedure Changes in serum creatinine after coronary artery catheterization
eGFR within 48-72 hours after coronary catheterization 48-72 hours post-procedure Changes in eGFR after coronary artery catheterization
Changes in complete blood cell count components from baseline to follow-up 48-72 hours post-procedure Changes in complete blood cell count components after coronary artery catheterization
Length of hospital stay 48-72 hours post-procedure Length of hospital stay
In-hospital mortality 48-72 hours post-procedure In-hospital mortality after coronary artery catheterization
Post-procedure atrial fibrillation 48-72 hours post-procedure Atrial fibrillation after coronary artery catheterization
Post-procedure acute coronary syndrome (ACS) events 48-72 hours post-procedure Recurrent acute coronary syndrome after coronary artery catheterization
Post-procedure cerebrovascular events 48-72 hours post-procedure Cerebrovascular events after coronary artery catheterization
Re-intervention 48-72 hours post-procedure Repeated coronary artery catheterization
Post-procedure bleeding 48-72 hours post-procedure Bleeding events after coronary artery catheterization
Pulmonary embolism 48-72 hours post-procedure Pulmonary embolism after coronary artery catheterization
Trial Locations
- Locations (1)
Rajaie cardiovascular medical and research center
🇮🇷Tehran, Iran, Islamic Republic of