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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
History of Changes

September 17, 2007
July 24, 2010
June 2007
May 2010   (final data collection date for primary outcome measure)
Incidence of Contrast Induced nephropathy [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
Incidence of Contrast Induced nephropathy [ Time Frame: 48 hours ]
Complete list of historical versions of study NCT00531765 on ClinicalTrials.gov Archive Site
Not Provided
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 ]
Not Provided
Not Provided
 
Sodium Bicarbonate in Preventing Contrast Induced Nephropathy
Sodium Bicarbonate in Preventing Contrast Induced Nephropathy (SIPCIN): A Randomized Controlled Study

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

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Contrast Induced Nephropathy
Other: sodium bicarbonate infusion
short infusion of sodium bicarbonate
  • Active Comparator: 1
    hydration with normal saline
    Intervention: Other: sodium bicarbonate infusion
  • Experimental: 2
    hydration with sodium bicarbonate
    Intervention: Other: sodium bicarbonate infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
May 2010
May 2010   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Saudi Arabia
 
NCT00531765
RAC 2071003
No
Fawaz Alturki, King Faisal Specialist Hospital & Research center
King Faisal Specialist Hospital & Research Center
Not Provided
Principal Investigator: Fawaz Al Turki, MD King Faisal Specialist Hospital & Research Center
King Faisal Specialist Hospital & Research Center
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP