Sodium Bicarbonate in Preventing Contrast Induced Nephropathy - Full Text View

Sodium Bicarbonate in Preventing Contrast Induced Nephropathy (SIPCIN)

This study is currently recruiting participants.

Verified by King Faisal Specialist Hospital & Research Center, September 2007

First Received: September 17, 2007 No Changes Posted

Sponsored by:	King Faisal Specialist Hospital & Research Center
Information provided by:	King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:	NCT00531765

Purpose

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

Condition	Intervention
Contrast Induced Nephropathy	Drug: sodium bicarbonate infusion

Drug Information available for: Sodium bicarbonate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Sodium Bicarbonate in Preventing Contrast Induced Nephropathy (SIPCIN): A Randomized Controlled Study

Further study details as provided by King Faisal Specialist Hospital & Research Center:

Primary Outcome Measures:

Incidence of Contrast Induced nephropathy [ Time Frame: 48 hours ]

Secondary Outcome Measures:

Incidence of in-hospital morbidity (such as need for hemo-dialysis, development of volume overload) and mortality as well as efficacy and safety of the two strategies in relation to the presence of CIN risk factors. [ Time Frame: one week ]

Estimated Enrollment:	220
Study Start Date:	June 2007
Estimated Study Completion Date:	July 2008

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00531765

Contacts

Contact: Muhammad M Hammami, MD, PhD

966 1 442 4527

muhammad@kfshrc.edu.sa

Locations

Saudi Arabia
King Faisal Specialist Hospital & Research Center	Recruiting
Riyadh, Saudi Arabia, 11211
Principal Investigator: Fawaz Al-Turki, MD
Principal Investigator: Mohammed Al Sunaid, MD
King Faisal Specialist Hospital & Research Center	Recruiting
Riyadh, Saudi Arabia, 11211

Sponsors and Collaborators

King Faisal Specialist Hospital & Research Center

Investigators

Principal Investigator:

Fawaz Al Turki, MD

King Faisal Specialist Hospital & Research Center

More Information

No publications provided

Study ID Numbers:	RAC 2071003
Study First Received:	September 17, 2007
Last Updated:	September 17, 2007
ClinicalTrials.gov Identifier:	NCT00531765 History of Changes
Health Authority:	Saudi Arabia: Research Advisory Council

Keywords provided by King Faisal Specialist Hospital & Research Center:

contrast-induced-nephropathy,
cardiac cath
creatinine
contrast
nephropathy

Study placed in the following topic categories:

Urologic Diseases
Kidney Diseases

Additional relevant MeSH terms:

Urologic Diseases
Kidney Diseases

ClinicalTrials.gov processed this record on May 07, 2009