CTI-01 (Ethyl Pyruvate) Safety and Complication Prevention in Cardiac Surgery Patients on Cardiopulmonary Bypass (CPB)
Public ClinicalTrials.gov record NCT00107666. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Over 500,000 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.
Study identification
- NCT ID
- NCT00107666
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 150 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2005 (Type not available)
- Primary completion
- Not listed
- Completion
- Apr 2006 (Type not available)
- Last update posted
- Mar 17, 2006
2005 – 2006
United States locations
- U.S. sites
- 17
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Saddleback Memorial Medical Center | Laguna Hills | California | 92653 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| Kaiser Permanente | San Francisco | California | 94115 | — |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| Research Support Personnel | Wichita | Kansas | 67208 | — |
| Peninsula Regional Medical Center | Salisbury | Maryland | 21801 | — |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | — |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | — |
| NYU Medical Center | New York | New York | 10016 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| East Carolina University - Brody School of Medicine | Greenville | North Carolina | 27834 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Chester County Hospital - The Cardiovasular Center | West Chester | Pennsylvania | 19380 | — |
| St. Luke's Episcopal Hospital/Texas Heart Institute | Houston | Texas | 77030 | — |
| MultiCare Health System | Tacoma | Washington | 98405 | — |
| Medical College of Wisconsin - VA Medical Center | Milwaukee | Wisconsin | 53295 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00107666, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 17, 2006 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00107666 live on ClinicalTrials.gov.