Expired Study
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La Jolla, California 92037


Purpose:

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 to successful spontaneous breathing trial, ventilator free days, ICU free days, hospital free days, and mortality.


Criteria:

Inclusion Criteria: - Age 18 years of age - Evidence of CTEPH - Acceptable surgical candidate Exclusion Criteria: - BMI > 40 - Patient undergoing lung biopsy or CABG at time of surgery


Study is Available At:


Original ID:

080721


NCT ID:

NCT00747045


Secondary ID:


Study Acronym:


Brief Title:

Lung Protective Ventilation in Pulmonary Thromboendarterectomy (PTE) Patients


Official Title:

A Prospective Single Blind Controlled Study to Assess the Efficacy of a Lung Protective Ventilation Strategy in the Prevention of Reperfusion Lung Injury Following PTE


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, San Diego


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

128


Enrollment Type:

Actual


Overall Contact Information

Official Name:Kim M Kerr, MD
Principal Investigator
UCSD Medical Center

Study Dates

Start Date:August 2008
Completion Date:March 2011
Completion Type:Actual
Primary Completion Date:March 2011
Primary Completion Type:Actual
Verification Date:December 2014
Last Changed Date:December 2, 2014
First Received Date:September 3, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Mortality
Time Frame:28 Days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Hospital Free Days
Time Frame:28 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:ICU free days
Time Frame:28 days
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Incidence of Reperfusion Lung Injury
Time Frame:72 Hours
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:Ventilation Strategy
Description:Comparison of low vs standard tidal volumes in patients undergoing PTE
Arm Name:Low tidal volume

Study Arms

Study Arm Type:Active Comparator
Arm Name:Usual care
Description:Tidal volume of 10 mL/Kg ideal body weight
Study Arm Type:Experimental
Arm Name:Low tidal volume
Description:Tidal volume of 6 mL/Kg ideal body weight

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, San Diego

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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