Back to resultsSodium Bicarbonate in Preventing Contrast Induced Nephropathy (SIPCIN)
Primary Purpose
Contrast Induced Nephropathy
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
sodium bicarbonate infusion
Sponsored by
About this trial
This is an interventional prevention trial for Contrast Induced Nephropathy focused on measuring contrast-induced-nephropathy,, cardiac cath, creatinine, contrast, nephropathy
Eligibility 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).
Sites / Locations
- King Faisal Specialist Hospital & Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
hydration with normal saline
hydration with sodium bicarbonate
Outcomes
Primary Outcome Measures
Incidence of Contrast Induced nephropathy
Secondary Outcome Measures
Full Information
NCT ID
NCT00531765
First Posted
September 17, 2007
Last Updated
July 24, 2010
Sponsor
King Faisal Specialist Hospital & Research Center
1. Study Identification
Unique Protocol Identification Number
NCT00531765
Brief Title
Sodium Bicarbonate in Preventing Contrast Induced Nephropathy
Acronym
SIPCIN
Official Title
Sodium Bicarbonate in Preventing Contrast Induced Nephropathy (SIPCIN): A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
King Faisal Specialist Hospital & Research Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast Induced Nephropathy
Keywords
contrast-induced-nephropathy,, cardiac cath, creatinine, contrast, nephropathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
hydration with normal saline
Arm Title
2
Arm Type
Experimental
Arm Description
hydration with sodium bicarbonate
Intervention Type
Other
Intervention Name(s)
sodium bicarbonate infusion
Intervention Description
short infusion of sodium bicarbonate
Primary Outcome Measure Information:
Title
Incidence of Contrast Induced nephropathy
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fawaz Al Turki, MD
Organizational Affiliation
King Faisal Specialist Hospital & Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Faisal Specialist Hospital & Research Center
City
Riyadh
ZIP/Postal Code
11211
Country
Saudi Arabia
12. IPD Sharing Statement
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Sodium Bicarbonate in Preventing Contrast Induced Nephropathy
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