Sodium Bicarbonate in Preventing Contrast Induced Nephropathy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00531765

Acronym

SIPCIN

Enrollment

220

Registered

2007-09-19

Start date

2007-06-30

Completion date

2010-05-31

Last updated

2010-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contrast Induced Nephropathy

Keywords

contrast-induced-nephropathy,, cardiac cath, creatinine, contrast, nephropathy

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.

Interventions

OTHERsodium bicarbonate infusion

short infusion of sodium bicarbonate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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).

Design outcomes

Primary

Measure	Time frame
Incidence of Contrast Induced nephropathy	48 hours

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026