Sodium Bicarbonate in Preventing Contrast Induced Nephropathy (SIPCIN)
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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 |
- 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 |
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| Saudi Arabia | |
| King Faisal Specialist Hospital & Research Center | |
| Riyadh, Saudi Arabia, 11211 | |
| 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 June 18, 2013