Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472563
Status:
COMPLETED
Last Update Posted:
2008-05-06
First Post:
2007-05-10
Brief Title:
Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate
Sponsor:
Universidad de Antioquia
Organization:
Universidad de Antioquia
Study Overview
Official Title:
Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate
Status:
COMPLETED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMEC
Brief Summary:
Deterioration of kidney renal function occurs in a minority of people due to contrast-required procedures The purpose of this study is to compare two different interventions to reduce the risk of kidney injury after contrast medium exposition
We will perform a randomized clinical trial following a modification of a previously published protocol Merten et alJAMA 2004291192328-34 Patients will be randomly assigned to one of two groups of treatment Group A will receive 1 cckghour of 09 saline infusion starting 12 hours before and continuing 12 hours after the procedure Group B will receive 3 cckg of sodium bicarbonate solution for one hour prior to procedure then drip rate will be decreased to 1 cckghour until 6 hours post procedure
We will perform a randomized clinical trial following a modification of a previously published protocol Merten et alJAMA 2004291192328-34 Patients will be randomly assigned to one of two groups of treatment Group A will receive 1 cckghour of 09 saline infusion starting 12 hours before and continuing 12 hours after the procedure Group B will receive 3 cckg of sodium bicarbonate solution for one hour prior to procedure then drip rate will be decreased to 1 cckghour until 6 hours post procedure
Detailed Description:
We will perform a randomized clinical trial following a modification of a previously published protocol Merten et alJAMA 2004291192328-34 Patients will be randomly assigned to one of two groups of treatment Group A will receive 1 cckghour of 09 saline infusion starting 12 hours before and continuing 12 hours after the procedure Group B will receive 3 cckg of sodium bicarbonate solution for one hour prior to procedure then drip rate will be decreased to 1 cckghour until 6 hours post procedure
Phase 23 study Study Type Interventional Study Design Prevention Randomized Open Label Active Control Parallel Assignment Efficacy Study
Subjects Consecutive samples of all inpatients who meet the inclusion criteria
Primary outcomes Development of contrast induced nephropathy defined as an increase in serum creatinine of 25 or more within 48 h after administration of contrast
Secondary outcomes change in serum bicarbonate change in serum potassium change in serum creatinine
Expected total enrollment 212
Allocation Assignment Patients who meet inclusion criteria and agree to participate in the study will be assigned by a random number table to saline or bicarbonate using closed envelopes and stratifying according to history of diabetes and type of procedure cardiac catheterism or others
Condition Contrast Induced Nephropathy
Intervention 75 cc of sodium bicarbonate 84 mixed in 425 cc of D5W
Gender both Age 18 years of age Recruitment Status participants are currently being recruited
Facility location
Universidad de Antioquia Internal Medicine Department Hospital Universitario San Vicente de Paul Medellin Colombia
Phase 23 study Study Type Interventional Study Design Prevention Randomized Open Label Active Control Parallel Assignment Efficacy Study
Subjects Consecutive samples of all inpatients who meet the inclusion criteria
Primary outcomes Development of contrast induced nephropathy defined as an increase in serum creatinine of 25 or more within 48 h after administration of contrast
Secondary outcomes change in serum bicarbonate change in serum potassium change in serum creatinine
Expected total enrollment 212
Allocation Assignment Patients who meet inclusion criteria and agree to participate in the study will be assigned by a random number table to saline or bicarbonate using closed envelopes and stratifying according to history of diabetes and type of procedure cardiac catheterism or others
Condition Contrast Induced Nephropathy
Intervention 75 cc of sodium bicarbonate 84 mixed in 425 cc of D5W
Gender both Age 18 years of age Recruitment Status participants are currently being recruited
Facility location
Universidad de Antioquia Internal Medicine Department Hospital Universitario San Vicente de Paul Medellin Colombia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None