Measurement of Extravascular Lung Water to Detect and Predict Primary Graft Dysfunction Following Lung Transplant
Recruitment status was Not yet recruiting
Lung transplantation is a life-saving treatment for patients with advanced lung disease. A common complication following lung transplantation is injury to the new lungs as they receive the flow of blood from the recipient after a period of cold storage during transportation. This is known as primary graft dysfunction (PGD, poor functioning of the new lung). The treatment of PGD involves trying to protect the lung from further injury by careful use of the breathing machine, and in giving the minimal required amount of intravenous fluids to patients. In critically ill patients, however, it is often difficult to determine exactly how much fluid is needed. A new monitor allows us to determine how much fluid has leaked into the damaged lungs. This in turn may help determine if patients can tolerate more fluid administration in situations where they are in shock versus having their blood pressure supported by additional medications..
This study will determine if this new method of measuring the leakage of fluid into the lungs can predict the presence and severity of PGD and will determine if there is a certain threshold that can differentiate between those with and without PGD. The investigators will also compare this method to other traditional methods used to measure fluid leak into the lungs.
This method has never been properly evaluated in lung transplant patients. It may provide a useful clinical tool to monitor and hopefully eventually guide the treatment of lung transplant patients after surgery.
Primary Graft Dysfunction
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Measurement of Extravascular Lung Water to Detect and Predict Primary Graft Dysfunction Following Lung Transplant|
- Using Extravascular Lung Water (EVLW) to Discriminate Between Those With or Without Primary Graft Dysfunction (PGD) After 24 Hours. [ Time Frame: 24 hours following lung transplant ] [ Designated as safety issue: Yes ]We will evaluate the optimal threshold of EVLW for discriminating between the presence versus absence of PGD. Our primary analysis will consider the measurements of EVLW obtained at 24 hours with simultaneous (blinded) determinations of PGD. The optimal threshold will be determined using diagnostic odds ratios that maximize sensitivity and specificity.
- Discriminating the Presence and Severity of PGD [ Time Frame: 72 hours following lung transplant ] [ Designated as safety issue: Yes ]We will evaluate the optimal cutpoints of EVLW for identifying PGD at multiple time points within the first 72 hours following surgery and we will evaluate the ability of EVLW to predict different grades of PGD.
- Associations between EVLW and PGD [ Time Frame: 72 hours following lung transplant ] [ Designated as safety issue: Yes ]We will determine whether higher levels of EVLW across patients are predictive of greater degrees of PGD, and how these associations change over time. We will first establish the range and distribution of EVLW numbers across patients with and without PGD and over time. These ranges of EVLW will be compared to the previously described ranges of normal and abnormal values in previous populations that have been described in the literature (e.g. ARDS and sepsis).
- Correlation Between EVLW and Other Surrogates of Pulmonary Edema [ Time Frame: 72 hours following lung transplant ] [ Designated as safety issue: No ]At each time point, the EVLW will be compared to the current surrogates of pulmonary edema used to guide current management of PGD including chest xray evidence of bilateral airspace disease, central venous pressure, fluid balance, oxygenation index, Partial pressure of oxygen:Fraction of inspired oxygen ratio and daily weights. These values will be compared to determine which best correlate with the presence of PGD.
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Bilateral Lung Transplant
All patients undergoing bilateral lung transplant for any indication will be considered for enrollment in the study. The characteristics of measurements of extravascular lung water will be compared following surgery in those who develop primary graft dysfunction compared to those who do not.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01605214
|Contact: John Granton, MD, FRCPCfirstname.lastname@example.org|
|Contact: Laveena Munshi, MD, FRCPC||416-340-4800 ext email@example.com|
|Toronto General Hospital|
|Toronto, Ontario, Canada, M5G 2C4|
|Principal Investigator:||John Granton, MD, FRCPC||University Health Network, Toronto|