Sodium Bicarbonate in Preventing Contrast Induced Nephropathy

Contrast Induced Nephropathy Clinical Trial

— SIPCIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00531765
• Other study ID #: RAC 2071003
• Status: Completed
• Phase: N/A
• First received: September 17, 2007
• Last updated: July 24, 2010
• Start date: June 2007
• Est. completion date: May 2010

Study information

• Verified date: July 2010
• Source: King Faisal Specialist Hospital & Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Research Advisory Council
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contrast Induced Nephropathy
• Kidney Diseases

Intervention

Other:
• sodium bicarbonate infusion
short infusion of sodium bicarbonate

Locations

Country	Name	City	State
Saudi Arabia	King Faisal Specialist Hospital & Research Center	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Faisal Specialist Hospital & Research Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Contrast Induced nephropathy		48 hours	Yes