Sodium Bicarbonate in Preventing Contrast Induced Nephropathy

Not Applicable

Completed

• Conditions: Contrast Induced Nephropathy
• Interventions: Other: sodium bicarbonate infusion

• Registration Number: NCT00531765
• Lead Sponsor: King Faisal Specialist Hospital & Research Center

Brief Summary

We plan to conduct an open-label, randomized, stratified, parallel-group study to compare normal saline infusion to sodium bicarbonate infusion.

Detailed Description

We plan to conduct an open-label, randomized, stratified, parallel-group study to compare normal saline infusion to sodium bicarbonate infusion. 220 adult patients scheduled for routine cardiac catheterization will be enrolled. They will stratified according to the presence or absence of DM, or an estimated GER of less than 60 ml/hr before being block-randomized to the two groups. The incidence of CIN will be determined based on the average of two measurements of creatinine level before and 48 hours after the procedure, and an increase of 25% or 0.5 mg/dL (44.2 umol/L) or more.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-09-17
• Study First Submitted QC: 2007-09-17
• Study First Posted: 2007-09-19
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-24
• Last Update Posted: 2010-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

All adult patients (18 years and above) who are scheduled for cardiac catechization and have abnormal but stable renal function will be eligible for enrollment. Abnormal renal function is defined as a creatinine level exceeding the normal range (more than 115 or 96 um/L in males and females, respectively, in KFSH&RC laboratories) or eGFR less than 60 ml/min

Exclusion Criteria

Patients who fall under any of the following categories will be excluded:

• Acute renal failure
• Cardiogenic shock
• Emergency cardiac catheterization
• Preexisting peritoneal or hemodialysis
• Pregnancy
• Recent exposure to contrast agent within the last 3 days
• Allergy to contrast or any of the above treatment
• Renal transplant,
• Patients who received dopamine, mannitol, theophyllin or other medications known to affect renal function within one week from cardiac cath
• Pulmonary edema / congestive heart failure
• Use of N-acetylcystein
• Patents on NSAIDS who can not stop using them for 48 hrs before and 48 hrs after procedure (except Aspirin).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	sodium bicarbonate infusion	hydration with normal saline
2	sodium bicarbonate infusion	hydration with sodium bicarbonate

Primary Outcome Measures

Name	Time	Method
Incidence of Contrast Induced nephropathy	48 hours

Trial Locations

Locations (1)

King Faisal Specialist Hospital & Research Center; 🇸🇦 Riyadh, Saudi Arabia