Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00190034
Status:
SUSPENDED
Last Update Posted:
2009-02-09
First Post:
2005-09-11
Brief Title:
Acetylcysteine Against Acute Renal Insult During Cardiopulmonary Bypass
Sponsor:
Far Eastern Memorial Hospital
Organization:
Far Eastern Memorial Hospital
Study Overview
Official Title:
N-Acetylcysteine Protects Against Acute Renal Insult in Patients With Abnormal Renal Function Undergoing Cardiopulmonary Bypass
Status:
SUSPENDED
Status Verified Date:
2006-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
opposite result
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether N-acetylcysteine is effective in the prophylaxis of post-cardiopulmonary bypass acute renal impairment
Detailed Description:
BACKGROUND Reactive oxygen species have been shown to cause contrast-induced nephrotoxicity CIN According to previous studies the N-acetylcysteine has been proved to be advantageous in the avoidance of CIN We seek to evaluate the efficacy of the antioxidant N-acetylcysteine in limiting the nephrotoxicity after cardiovascular surgery with cardiopulmonary bypass
METHODS We will prospectively study 60 patients who will receive a cardiovascular surgery with cardiopulmonary bypass Patients will be randomly assigned to receive either N-acetylcysteine 600 mg orally twice daily for 4 doses with 045 saline intravenously before and after cardiopulmonary bypass or placebo with 045 saline Serum creatinine and blood urea nitrogen will be measured before 48 h and 5 days after the operation procedure
Expected results Prophylactic oral administration of the antioxidant N-acetylcysteine along with hydration will significantly reduce the acute renal damage induced by CPB in patients with chronic renal insufficiency that need cardiovascular procedures
METHODS We will prospectively study 60 patients who will receive a cardiovascular surgery with cardiopulmonary bypass Patients will be randomly assigned to receive either N-acetylcysteine 600 mg orally twice daily for 4 doses with 045 saline intravenously before and after cardiopulmonary bypass or placebo with 045 saline Serum creatinine and blood urea nitrogen will be measured before 48 h and 5 days after the operation procedure
Expected results Prophylactic oral administration of the antioxidant N-acetylcysteine along with hydration will significantly reduce the acute renal damage induced by CPB in patients with chronic renal insufficiency that need cardiovascular procedures
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FEMH-93-C-030 | None | None | None |