Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00513825
Status:
COMPLETED
Last Update Posted:
2008-11-26
First Post:
2007-08-08
Brief Title:
Preventing Contrast Nephropathy With Sodium Bicarbonate in Patients With Pulmonary EdemaHeart FailureUncontrolled HTN
Sponsor:
Tehran University of Medical Sciences
Organization:
Tehran University of Medical Sciences
Study Overview
Official Title:
The Evaluation of the Effect of Sodium Bicarbonate Solution in Decreasing the Incidence of Contrast Induced Nephropathy CIN in Patients With Pulmonary EdemaSevere Heart Failure or Uncontrolled Hypertension
Status:
COMPLETED
Status Verified Date:
2008-11
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:
None
Brief Summary:
Radio Contrast Induced Nephropathy RCIN remains a well recognized complication in patients undergoing diagnostic or interventional procedures requiring radiographic contrast agents Recent studies have shown benefit in administering Sodium Bicarbonate over normal saline the uniformly accepted prophylaxy in preventing RCINBut most studies have excluded patients with history of pulmonary edema severe heart failureNYHA 3-4 uncontrolled hypertension or ejection fraction less than 30 Therefore the aim of this study is to evaluate the efficacy of sodium bicarbonate solved in half saline compared with infusion of half saline in prevention of RCIN in these groups of patients
Detailed Description:
Radio Contrast Induced Nephropathy RCIN remains a well recognized complication in patients undergoing diagnostic or interventional procedures requiring radiographic contrast agents and is the third leading cause of acquired acute renal failure in hospitalized patients Strategies for the prevention of radiocontrast nephropathy have focused on countering vasoconstriction pre-hydration fenoldopam and theophylline enhancing flow through the nephron diuretics or protection against oxygen-free-radical injury urinary alkalinization and N-acetylcysteine
Among all prophylactic measures that have been proposed adequate preprocedural and postprocedural hydration has demonstrated effectiveness in the prevention of radiocontrast nephropathy Thus it remains the most frequently applied measure in clinical practice
A Recent study in May 2004 have shown benefit in administering Sodium Bicarbonate over normal saline as a prophylaxySince alkalizing renal tubular fluid with bicarbonate may reduce injury
Most studies have excluded patients with history of pulmonary edema severe heart failureNYHA 3-4 uncontrolled hypertension or ejection fraction less than 30 and no specific protocol is tested for this group of patients This study focuses on preventing RCIN in this specific group of patients
Comparisons1075 cc NaCl 045 or 75 cc of sodium bicarbonate 84 solved in one liter of NaCl 045 Each fluid is infused at the rate of 3 mlkg hour one hour before the angiographic procedure continuing at the rate of 1 mlkg hour for 6 hours after the procedure Maximum rate of fluid permitted is that for a body weight of 110 Kg
Among all prophylactic measures that have been proposed adequate preprocedural and postprocedural hydration has demonstrated effectiveness in the prevention of radiocontrast nephropathy Thus it remains the most frequently applied measure in clinical practice
A Recent study in May 2004 have shown benefit in administering Sodium Bicarbonate over normal saline as a prophylaxySince alkalizing renal tubular fluid with bicarbonate may reduce injury
Most studies have excluded patients with history of pulmonary edema severe heart failureNYHA 3-4 uncontrolled hypertension or ejection fraction less than 30 and no specific protocol is tested for this group of patients This study focuses on preventing RCIN in this specific group of patients
Comparisons1075 cc NaCl 045 or 75 cc of sodium bicarbonate 84 solved in one liter of NaCl 045 Each fluid is infused at the rate of 3 mlkg hour one hour before the angiographic procedure continuing at the rate of 1 mlkg hour for 6 hours after the procedure Maximum rate of fluid permitted is that for a body weight of 110 Kg
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