SIPCIN: Sodium Bicarbonate in Preventing Contrast Induced Nephropathy

Sponsor

King Faisal Specialist Hospital & Research Center (Other)

Overall Status

Completed

CT.gov ID

NCT00531765

Collaborator

(none)

220

Enrollment

Location

Arms

Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Contrast Induced Nephropathy	Other: sodium bicarbonate infusion	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Sodium Bicarbonate in Preventing Contrast Induced Nephropathy (SIPCIN): A Randomized Controlled Study

Study Start Date :

Jun 1, 2007

Actual Primary Completion Date :

May 1, 2010

Actual Study Completion Date :

May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 hydration with normal saline	Other: sodium bicarbonate infusion short infusion of sodium bicarbonate
Experimental: 2 hydration with sodium bicarbonate	Other: sodium bicarbonate infusion short infusion of sodium bicarbonate

Arm

Intervention/Treatment

Active Comparator: 1

hydration with normal saline

Other: sodium bicarbonate infusion

short infusion of sodium bicarbonate

Experimental: 2

hydration with sodium bicarbonate

Other: sodium bicarbonate infusion

short infusion of sodium bicarbonate

Outcome Measures

Primary Outcome Measures

Incidence of Contrast Induced nephropathy [48 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).