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NCT00747045 · ClinicalTrials.gov registry record · NA
Lung Protective Ventilation in Pulmonary Thromboendarterectomy (PTE) Patients
A NA study of Acute Lung Injury and Chronic Thromboembolic Pulmonary Hypertension, sponsored by University of California, San Diego.
- Completed
- Registry status
- NA
- Development phase
- 128
- Enrollment target
- 1
- Study location
NCT00747045: Completed NA study of Acute Lung Injury and Chronic Thromboembolic Pulmonary Hypertension, sponsored by University of California, San Diego.
NCT00747045 is a NA study of Acute Lung Injury and Chronic Thromboembolic Pulmonary Hypertension that has completed, run by University of California, San Diego. The registered enrollment target is 128 participants, above the 113-participant average among 10 other Acute Lung Injury trials with a reported enrollment target (13% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00747045, a NA study of Acute Lung Injury and Chronic Thromboembolic Pulmonary Hypertension, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- NA
- Development phase
- 128 participants
- Enrollment target
- 1
- Study location
Study Summary
Chronic thromboembolic pulmonary hypertension (CTEPH) is caused by unresolved thromboemboli in the pulmonary arteries, which lead to pulmonary hypertension and, left untreated, right heart failure. This disease can be potentially cured by performing a pulmonary thromboendarterectomy (PTE) to remove the blood clots. The surgery is not without risk and the most worrisome complication is the development of a form of acute lung injury called reperfusion lung injury, which occurs in about 40 percent of patients. The landmark publication of the ARDSNET study demonstrated that a low tidal volume strategy of mechanical ventilation, decreased morbidity and mortality in patients who had acute respiratory distress syndrome (ARDS). Since then there have been some studies examining the role of a low tidal volume strategy in all patients who are mechanically ventilated. Some studies have demonstrated a decreased incidence of acute lung injury while others have failed to do the same. In patients at high risk for developing acute lung injury, such as patients undergoing PTE, there may be a benefit to using low tidal volumes to reduce the incidence of reperfusion lung injury. To assess the efficacy of a low tidal volume ventilation strategy in patients undergoing PTE, 134 patients will be randomized at the time of surgery to either low tidal volumes (6ml/kg of ideal body weight), or standard tidal volumes (10ml/kg of ideal body weight). Patients will be followed clinically to assess for the development of reperfusion lung injury. This will be defined as the development of hypoxemia (PaO2/FiO2 ratio less than 300) and chest infiltrates in the area of reperfused lung with no other identifiable etiology within the first 72 hours of surgery. Patients will also be assessed for other factors known to contribute to acute lung injury including: plateau pressures, peak inspiratory pressures, fluid balance, and number of transfusions received. Secondary endpoints of the study will be: time
Conditions Studied
Interventions
- OTHER Ventilation Strategy
Study Locations (1)
California
- UCSD - Thornton Hospital - La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2008-08 |
| Est. Completion | 2011-03 |
| Phase | NA |
What the finished NCT00747045 record still lists
NCT00747045 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, above the 113-participant average among 10 other Acute Lung Injury trials with a reported enrollment target (13% higher).
The record links to 2 conditions, with Acute Lung Injury appearing as the primary indexed condition, and to 1 intervention - of which Ventilation Strategy is the first listed.
NCT00747045 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00747045 about?
NCT00747045 is a clinical study titled "Lung Protective Ventilation in Pulmonary Thromboendarterectomy (PTE) Patients". Chronic thromboembolic pulmonary hypertension (CTEPH) is caused by unresolved thromboemboli in the pulmonary arteries, which lead to pulmonary hypertension and, left untreated, right heart failure. This disease can be potentially cured by performing a pulmonary thromboendarterectomy (PTE) to remove ...
What is the current status of trial NCT00747045?
This trial is currently completed. It is a NA study. The enrollment target is 128 participants. The study started on 2008-08. Estimated completion is 2011-03.
What conditions does trial NCT00747045 study?
This clinical trial studies the following conditions: Acute Lung Injury, Chronic Thromboembolic Pulmonary Hypertension.
What interventions are being tested in trial NCT00747045?
The interventions under investigation include: Ventilation Strategy (OTHER).
Who is sponsoring clinical trial NCT00747045?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00747045 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00747045's enrollment target sits among peer trials
128 4th of 10 higher than 7 of 10 other Acute Lung Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Lung Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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