Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00110201
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2005-05-04
Brief Title:
The Use of Nesiritide in Thoracic Aneurysm Repair to Prevent Acute Renal Failure
Sponsor:
Ejaz Abulate A MD
Organization:
Ejaz Abulate A MD
Study Overview
Official Title:
Prophylactic Use of Nesiritide Brain Natriuretic Peptide BNP for the Prevention of Acute Renal Failure in Thoracic Aortic Aneurysm Surgery Patients
Status:
UNKNOWN
Status Verified Date:
2005-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is to study the use of nesiritide in thoracic aneurysm repair to prevent acute renal failure
The study hypothesis Nesiritide given prophylactically prior to surgery may prevent acute renal failure requiring dialysis andor decrease mortality
The study hypothesis Nesiritide given prophylactically prior to surgery may prevent acute renal failure requiring dialysis andor decrease mortality
Detailed Description:
Acute renal failure is a major and serious complication of more than 200000 cardiovascular surgeries performed on adult Americans annually wwwstsorg The incidence of acute renal failure ARF after cardiac surgery depending on criteria used to define ARF is 1-5 in the absence of preexisting renal dysfunction The subset of patients with thoracic aortic aneurysm surgery have a higher risk for the development of postoperative ARF 25-40 - ARF defined as doubling of serum creatinine 13 - ARF defined as requirement for dialysis This risk is further increased by various peri-operative factors especially cardiopulmonary bypass time
The overall postoperative mortality rate for cardiovascular surgery is 22 but is much higher for thoracic aortic aneurysm surgery 8-10 for elective repair 25-50 for ruptured thoracic aorta aneurysm repair The major risk factor for thoracic aortic aneurysm surgery related mortality is post-operative ARF requiring dialysis When thoracic aortic aneurysm surgery is complicated by acute renal failure the mortality rate worsens to 50 Thus identifying ways to prevent acute renal failure may have a major impact on the outcome of cardiovascular surgery A retrospective study of the use of nesiritide in cardiovascular surgery patients by our group has demonstrated a tendency towards a decreased incidence of renal failure and mortality when the medication is used prophylactically
The overall postoperative mortality rate for cardiovascular surgery is 22 but is much higher for thoracic aortic aneurysm surgery 8-10 for elective repair 25-50 for ruptured thoracic aorta aneurysm repair The major risk factor for thoracic aortic aneurysm surgery related mortality is post-operative ARF requiring dialysis When thoracic aortic aneurysm surgery is complicated by acute renal failure the mortality rate worsens to 50 Thus identifying ways to prevent acute renal failure may have a major impact on the outcome of cardiovascular surgery A retrospective study of the use of nesiritide in cardiovascular surgery patients by our group has demonstrated a tendency towards a decreased incidence of renal failure and mortality when the medication is used prophylactically
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 |
|---|---|---|---|
| 20050059 | None | None | None |