Sodium Bicarbonate in Preventing Contrast Induced Nephropathy (SIPCIN)

This study has been completed.
Sponsor:
Information provided by:
King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:
NCT00531765
First received: September 17, 2007
Last updated: July 24, 2010
Last verified: July 2010
  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
Other: sodium bicarbonate infusion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Sodium Bicarbonate in Preventing Contrast Induced Nephropathy (SIPCIN): A Randomized Controlled Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incidence of Contrast Induced nephropathy [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 220
Study Start Date: June 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Locations
Saudi Arabia
King Faisal Specialist Hospital & Research Center
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

Responsible Party: Fawaz Alturki, King Faisal Specialist Hospital & Research center
ClinicalTrials.gov Identifier: NCT00531765     History of Changes
Other Study ID Numbers: RAC 2071003
Study First Received: September 17, 2007
Last Updated: July 24, 2010
Health Authority: Saudi Arabia: Research Advisory Council

Keywords provided by King Faisal Specialist Hospital & Research Center:
contrast-induced-nephropathy,
cardiac cath
creatinine
contrast
nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 30, 2014