Folic Acid for Prevention of Contrast Induced Nephropathy

Phase 4

• Conditions: Kidney Diseases; Urologic Diseases
• Interventions: Drug: Placebo; Drug: Folic acid

• Registration Number: NCT02444013
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary

The purpose of this study is to determine whether periprocedural administration of folic acid is effective in the prevention of contrast induced nephropathy in patients undergoing coronary CTA/angiography/angioplasty.

Detailed Description

Hyperhomocysteinemia is considered to be independently associated with a greater risk of contrast induced nephropathy (CIN) in previous studies. However, the relationship between homocysteine-lowering therapy and CIN remains uncertain. Folic acid is considered to be the most common agent for homocysteine-lowering therapy. Therefore, this study aims to determine whether periprocedural administration of folic acid is effective in the prevention of CIN. 400 patients undergoing coronary CTA/angiography/angioplasty are going to be initially enrolled. Of these patients,200 were randomly assigned to receive a standard dose of folic acid (5mg tid, given at least two days before the procedural and continued for two days after), 200 to receive placebo. Blood samples for estimations of serum creatinine were collected at 0, 24 and 48h of contrast agent administration. CIN is defined as an elevation of creatinine by ≥ 25% or ≥ 0.5 mg/dl from baseline within 48h. The occurrence of CIN and the major in-hospital clinical events were recorded and compared between the intervention and control groups.

Study Timeline

• Study First Submitted: 2015-04-07
• Status Verified: 2015-05
• Study Start: 2015-05
• Study First Submitted QC: 2015-05-11
• Last Update Submitted: 2015-05-11
• Study First Posted: 2015-05-14
• Last Update Posted: 2015-05-14
• Primary Completion: 2017-05
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Inpatients undergoing coronary CTA/angiography/angioplasty

Exclusion Criteria

• exposure to nephrotoxic drugs prior to or during the study period
• end-stage renal failure requiring dialysis
• allergy to iodine-containing contrast medium
• pregnancy
• refusal to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Oral placebo (1 tablet, tid) were given at least two days before CTA/angiography/angioplasty and continued for two days after.
Folic acid	Folic acid	Oral folic acid (5 mg, tid) were given at least two days before CTA/angiography/angioplasty and continued for two days after.

Primary Outcome Measures

Name	Time	Method
Occurrence of contrast-induced nephropathy	Within 48 hours after contrast exposure	Contrast-induced nephropathy is defined as an elevation of serum creatinine of more than 25% or ≥0.5 mg/dl (44 μmol/l) from baseline within 48 hours after contrast exposure

Secondary Outcome Measures

Name	Time	Method
Major in-hospital clinical events, including death and need for dialysis or hemofiltration	participants will be followed for the duration of hospital stay, an expected average of 10 days

Trial Locations

Locations (1)

Department of Cardiology, the Third Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China