Measurement of Extravascular Lung Water to Detect and Predict Primary Graft Dysfunction Following Lung Transplant

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University Health Network, Toronto.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Toronto General Hospital
Information provided by (Responsible Party):
John Granton, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01605214
First received: May 22, 2012
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

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.


Condition
Primary Graft Dysfunction

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
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)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients undergoing bilateral lung transplant for any indication will be considered to be enrolled in this study.

Criteria

Inclusion Criteria:

  • All consecutive bilateral lung transplant recipients

Exclusion Criteria:

  • Immediate need for extracorporeal life support following transplant (those requiring ECLS four hours after intensive care admission can be included as we would have obtained some EVLW measurements)
  • Contraindications to femoral artery catheterization (abdominal aortic aneurysm)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01605214

Contacts
Contact: John Granton, MD, FRCPC 416-340-4485 john.granton@uhn.ca
Contact: Laveena Munshi, MD, FRCPC 416-340-4800 ext 3100 laveena.munshi@utoronto.ca

Locations
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Toronto General Hospital
Investigators
Principal Investigator: John Granton, MD, FRCPC University Health Network, Toronto
  More Information

Publications:

Responsible Party: John Granton, Dr. John T. Granton, Associate Professor, Division Head of Respirology, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01605214     History of Changes
Other Study ID Numbers: UHNEVLW-1
Study First Received: May 22, 2012
Last Updated: July 12, 2012
Health Authority: Canada: Ministry of Health & Long Term Care, Ontario

Keywords provided by University Health Network, Toronto:
Extravascular Lung Water
Transpulmonary Thermodilution
Primary Graft Dysfunction
Ischemia Reperfusion Injury

Additional relevant MeSH terms:
Primary Graft Dysfunction
Reperfusion Injury
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on August 18, 2014