Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107666
Status:
TERMINATED
Last Update Posted:
2006-03-17
First Post:
2005-04-06
Brief Title:
CTI-01 Ethyl Pyruvate Safety and Complication Prevention in Cardiac Surgery Patients on Cardiopulmonary Bypass CPB
Sponsor:
Critical Therapeutics
Organization:
Critical Therapeutics
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Parallel-Group Multicenter Proof of Concept Clinical Study of CTI-01 in Patients Undergoing Major Cardiac Surgery With Cardiopulmonary Bypass
Status:
TERMINATED
Status Verified Date:
2006-03
Last Known Status:
None
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:
Over 500000 patients undergo cardiac surgery with CPB in the United States annually Although mortality rates have decreased with advances in perioperative care many patients are affected by postoperative organ dysfunction The incidence of complications may exceed 30 It has been speculated that an exaggerated inflammatory response to surgical trauma and the CPB machine are likely causes for this morbidity Factors predisposing organ dysfunction include tissue injury endotoxemia and oxidative stress High risk patients can be identified preoperatively through the validated Parsonnet Additive Risk Score CTI-01 has demonstrated potent anti-inflammatory and tissue protection activity in multiple animal models of disease including pancreatitis ischemia-reperfusion injury sepsis renal injury and endotoxemia These findings support its clinical use in critical care medicine including cardiac surgery Patients will receive a total of six doses administered intravenously just prior to and after surgery
Detailed Description:
None
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