Primary Graft DysfunctionNCT01605214
Measurement of Extravascular Lung Water to Detect and Predict Primary Graft Dysfunction Following Lung Transplant
An observational study of Primary Graft Dysfunction, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Primary graft dysfunction (PGD) is the most common cause of early morbidity and mortality following lung transplant and is characterized by acute lung injury and capillary leak leading to an increase in extravascular lung water index (ELWI) and impaired graft function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Graft Dysfunction
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2015to Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing bilateral lung transplant for any indication will be considered to be enrolled in this study.
Who may be able to join
- All consecutive bilateral lung transplant recipients
Who cannot join
- Immediate need for extracorporeal life support following transplant (those requiring ECLS four hours after intensive care admission can be included as the investigators would have obtained some ELWI measurements)
- Contraindications to femoral artery catheterization (eg, abdominal aortic aneurysm)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G 2C4
John Granton, MD, 4163404800 ext. 4485, john.granton@uhn.ca
Laveena Munshi, MD, 4165864800 ext. 6571, laveena.munshi@uhn.ca
About this study
Primary graft dysfunction (PGD) is the most common cause of early morbidity and mortality following lung transplant and is characterized by acute lung injury and capillary leak leading to an increase in extravascular lung water index (ELWI) and impaired graft function. PGD has many features in common with acute respiratory distress syndrome (ARDS). PGD may be life-threatening and can also lead to impaired long term lung function. In ARDS, a restrictive fluid strategy has been associated with an improvement in lung function and outcomes. Accurate methods of evaluating, quantifying and guiding the hemodynamic / fluid management and limiting the extent of ELWI that accumulates in the setting of PGD are lacking. Using transpulmonary thermodilution to estimate ELWI and the pulmonary permeability index (PPI) represents a novel approach to fluid management, which has been used in patients with ARDS, but to date not in the transplant setting. To determine if these measurements may better guide the management of lung transplant patients, the investigators first wish to establish whether these methods are able to predict the onset of clinical pulmonary edema earlier, whether they correlated with traditional markers of PGD, and whether they may be useful for predicting outcomes.
AIM 1: The investigators will evaluate the correlation between ELWI and current surrogates of pulmonary edema in lung transplant patients with and without Primary Graft Dysfunction (PGD)
Read more
AIM 2: The investigators will correlate the use of ELWI and PPI to determine the presence and severity of PGD.
AIM 3: a) The investigators will determine whether early measurements of ELWI and PPI can predict the onset of PGD.
- Across different strata of PGD, the investigators will determine whether ELWI and PPI have a differential effect on duration of mechanical ventilation.
The results of the study will be used for the following:
- Provide the rationale for routine monitoring of ELWI to detect PGD if found to be more discriminatory and have a stronger association with outcome compared to the current gold standard.
- Provide the means of early identification of those as risk of developing PGD in order to guide management decisions or future therapeutic interventions aimed at preventing or treating PGD.
- Provide the requisite groundwork for a clinical trial comparing the effects of an ELWI-driven protocol versus usual care on ICU outcomes in lung transplant recipients.
- Conditions
- Primary Graft Dysfunction
- Keywords
- Extravascular Lung Water, Transpulmonary Thermodilution, Primary Graft Dysfunction, Ischemia Reperfusion Injury
- Medical subject headings
- Primary Graft Dysfunction, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
AIM 1: The presence of pulmonary edema on chest X ray (CXR) at 24 hours determined by blinded CXR reviewers
On post operative day 1 (24 hours following lung transplant), the investigators will evaluate whether extravascular lung water measured at 24 hours correlates with pulmonary edema determined by reviewers of the CXR blinded to the extravascular lung water measurement. The investigators will use Pearson's correlation for normally distributed and Spearman's correlation for non-normally distributed values. A correlation coefficient of >0.8 will be considered a strong correlation
Measured: 24 hours following lung transplant
AIM 2: The presence of primary graft dysfunction at 24 hours determined by CXR evidence of bilateral airspace disease and Pa02/FiO2 ratio threshold by reviewers blinded to the extravascular lung water and pulmonary permeability measurements at 24
24 hours following lung transplant, the investigators will evaluate whether the combination of extravascular lung water and pulmonary permeability measurements at 24 hours correlate with the presence and severity of primary graft dysfunction (PGD) at 24 hours. The median extravascular lung water and pulmonary permeability measurements will be calculated. The combinations of above/below median extravascular lung water with above/below median pulmonary permeability will be correlated to the presence of PGD. (eg. high ELWI + high PPI, high ELWI + low PPI, low ELWI + high PPI, low ELWI + low PPI) using Pearson's and Spearman's correlation where appropriate.
Grade 0 PGD - Normal CXR AND a PaO2/FiO2 >300mmHg Grade 1 PGD - Bilateral airspace disease on CXR with AND a PaO2/FiO2 >300mmHg Grade 2 PGD - Bilateral airspace disease on CXR with AND a PaO2/FiO2 200-300mmHg Grade 3 PGD - Bilateral airspace disease on CXR with AND a PaO2/FiO2 <200mmHg.
Measured: 24 hours
AIM 3: The presence of primary graft dysfunction at 24 hours determined by CXR and Pa02/FiO2 ratio by reviewers blinded to early (time 0) extravascular lung water and pulmonary permeability measurements
The investigators will compare whether immediate (time 0) post operative measurements of the combination of extravascular lung water and pulmonary permeability can predict the later onset (24 hours) of primary graft dysfunction. The combinations of above/below median extravascular lung water with above/below median pulmonary permeability will be correlated to the presence of PGD. (eg. high ELWI + high PPI, high ELWI + low PPI, low ELWI + high PPI, low ELWI + low PPI) using logistic regression.
Grade 0 PGD - Normal CXR AND a PaO2/FiO2 >300mmHg Grade 1 PGD - Bilateral airspace disease on CXR with AND a PaO2/FiO2 >300mmHg Grade 2 PGD - Bilateral airspace disease on CXR with AND a PaO2/FiO2 200-300mmHg Grade 3 PGD - Bilateral airspace disease on CXR with AND a PaO2/FiO2 <200mmHg.
Measured: Time 0 extravascular lung water and pulmonary permeability measurements and primary graft dysfunction at 24 hours
Secondary outcomes (5)
AIM 1: The presence of pulmonary edema on chest X ray at 48 and 72 hours evaluated by CXR reviewers blinded to the extravascular lung water measurements measured at 48 and 72 hours
On post operative day 2 and 3 (48 and 72 hours following lung transplant), the investigators will evaluate whether the extravascular lung water measurements taken at 48 and 72 hours correlate with pulmonary edema determined by CXR. The investigators will use Pearson's correlation for normally distributed and Spearman's correlation for non-normally distributed values. A correlation coefficient of >0.8 will be considered a strong correlation
Measured: 48 and 72 hours following lung transplant
AIM 2: The presence of late primary graft dysfunction determined by CXR and PaO2/FiO2 ratio evaluated by reviewers blinded to the extravascular lung water and pulmonary permeability measurements evaluated at 48 and 72 hours
On post operative day 2 and 3 (48 and 72 hours following lung transplant), the investigators will evaluate whether the combination of of extravascular lung water and pulmonary permeability measurements taken at 48 and 72 hours correlate with the presence and severity of primary graft dysfunction (PGD). The combinations of above/below median extravascular lung water with above/below median pulmonary permeability will be correlated to the presence of PGD. (eg. high ELWI + high PPI, high ELWI + low PPI, low ELWI + high PPI, low ELWI + low PPI) using Pearson's and Spearman's correlation where appropriate.
Grade 0 PGD - Normal CXR AND a PaO2/FiO2 >300mmHg Grade 1 PGD - Bilateral airspace disease on CXR with AND a PaO2/FiO2 >300mmHg Grade 2 PGD - Bilateral airspace disease on CXR with AND a PaO2/FiO2 200-300mmHg Grade 3 PGD - Bilateral airspace disease on CXR with AND a PaO2/FiO2 <200mmHg.
Measured: 48 and 72 hours following lung transplant
AIM 3: The presence of late primary graft dysfunction (48 and 72 hours) determined by CXR and PaO2/FiO2 ratio evaluated by reviewers blinded to the extravascular lung water and pulmonary permeability measurements at time 0
The investigators will evaluate whether the early (time 0 hours) measurements of the combination of extravascular lung water and pulmonary permeability index can predict the development of late primary graft dysfunction (PGD) at 48 hours or 72 hours. The combinations of above/below median extravascular lung water with above/below median pulmonary permeability will be correlated to the presence of PGD. (eg. high ELWI + high PPI, high ELWI + low PPI, low ELWI + high PPI, low ELWI + low PPI) using Pearson's and Spearman's correlation where appropriate.
Grade 0 PGD - Normal CXR AND a PaO2/FiO2 >300mmHg Grade 1 PGD - Bilateral airspace disease on CXR with AND a PaO2/FiO2 >300mmHg Grade 2 PGD - Bilateral airspace disease on CXR with AND a PaO2/FiO2 200-300mmHg Grade 3 PGD - Bilateral airspace disease on CXR with AND a PaO2/FiO2 <200mmHg.
Measured: Extravascular lung water and pulmonary permeability measurements at time 0 hours, primary graft dysfunction determination at 48 or 72 hours
AIM 3: The presence of any primary graft dysfunction determined by CXR and PaO2/FiO2 ratio (24, 48 or 72 hours) evaluated by reviewers blinded to the early extravascular lung water and pulmonary permeability measurements (6 hours and 12 hours)
The investigators will evaluate whether the early (time 6 hours and 12 hours) measurements of the combination of extravascular lung water and pulmonary permeability index can predict the development of primary graft dysfunction (PGD) at 24, 48 or 72 hours. The combinations of above/below median extravascular lung water with above/below median pulmonary permeability will be correlated to the presence of PGD. (eg. high ELWI + high PPI, high ELWI + low PPI, low ELWI + high PPI, low ELWI + low PPI) using logistic regression.
Grade 0 PGD - Normal CXR AND a PaO2/FiO2 >300mmHg Grade 1 PGD - Bilateral airspace disease on CXR with AND a PaO2/FiO2 >300mmHg Grade 2 PGD - Bilateral airspace disease on CXR with AND a PaO2/FiO2 200-300mmHg Grade 3 PGD - Bilateral airspace disease on CXR with AND a PaO2/FiO2 <200mmHg.
Measured: Extravascular lung water and pulmonary permeability measurements at 6 hours and 12 hours, any primary graft dysfunction determined at 24, 48 or 72 hours
AIM 3: Duration of mechanical ventilation
The investigators will evaluate whether extravascular lung water and pulmonary permeability measurements at 24 hours, regardless of primary graft dysfunction grade, correlates with duration of mechanical ventilation during the first intensive care unit stay following lung transplant using linear regression analysis
Measured: Extravascular lung water and pulmonary permeability measurements at 24 hours, Hospital admission following lung transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2012 (estimated)
- Study startOct 2015
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Primary Graft DysfunctionStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Toronto General Hospital
- Responsible party
- Principal investigator, John Granton, University Health Network, Toronto
- Investigators
- John Granton, MD, FRCPC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605214
- Sponsor's protocol ID
- UHNEVLW-1
- Status last verified
- Jan 2018
- First submitted
- 22 May 2012
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Monnet X, Anguel N, Osman D, Hamzaoui O, Richard C, Teboul JL. Assessing pulmonary permeability by transpulmonary thermodilution allows differentiation of hydrostatic pulmonary edema from ALI/ARDS. Intensive Care Med. 2007 Mar;33(3):448-53. doi: 10.1007/s00134-006-0498-6. Epub 2007 Jan 13.
PubMed 17221189Sakka SG, Ruhl CC, Pfeiffer UJ, Beale R, McLuckie A, Reinhart K, Meier-Hellmann A. Assessment of cardiac preload and extravascular lung water by single transpulmonary thermodilution. Intensive Care Med. 2000 Feb;26(2):180-7. doi: 10.1007/s001340050043.
PubMed 10784306Chung FT, Lin HC, Kuo CH, Yu CT, Chou CL, Lee KY, Kuo HP, Lin SM. Extravascular lung water correlates multiorgan dysfunction syndrome and mortality in sepsis. PLoS One. 2010 Dec 16;5(12):e15265. doi: 10.1371/journal.pone.0015265.
PubMed 21187890Della Rocca G, Costa GM, Coccia C, Pompei L, Di Marco P, Pietropaoli P. Preload index: pulmonary artery occlusion pressure versus intrathoracic blood volume monitoring during lung transplantation. Anesth Analg. 2002 Oct;95(4):835-43, table of contents. doi: 10.1097/00000539-200210000-00009.
PubMed 12351254Michard F, Alaya S, Zarka V, Bahloul M, Richard C, Teboul JL. Global end-diastolic volume as an indicator of cardiac preload in patients with septic shock. Chest. 2003 Nov;124(5):1900-8. doi: 10.1378/chest.124.5.1900.
PubMed 14605066Sakka SG, Klein M, Reinhart K, Meier-Hellmann A. Prognostic value of extravascular lung water in critically ill patients. Chest. 2002 Dec;122(6):2080-6. doi: 10.1378/chest.122.6.2080.
PubMed 12475851Hillinger S, Hoerstrup SP, Zollinger A, Weder W, Schmid RA, Stammberger U. A new model for the assessment of lung allograft ischemia/reperfusion injury. J Invest Surg. 2000 Jan-Feb;13(1):59-65. doi: 10.1080/089419300272267.
PubMed 10741952Rocca GD, Coccia C, Costa GM, Pompei L, Di Marco P, Pierconti F, Cappa M, Venuta F, Pietropaoli P. Is very early extubation after lung transplantation feasible? J Cardiothorac Vasc Anesth. 2003 Feb;17(1):29-35. doi: 10.1053/jcan.2003.6.
PubMed 12635057
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Extravascular Lung Water to Detect and Predict Primary Graft Dysfunction Following Lung Transplant
- ClinicalTrials.gov ID
- NCT01605214
- Acronym / sponsor ID
- UHNEVLW-1
- Conditions
- Primary Graft Dysfunction
- Keywords
- Extravascular Lung Water, Transpulmonary Thermodilution, Primary Graft Dysfunction, Ischemia Reperfusion Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Toronto General Hospital
- Study start
- Oct 2015
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 24 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary graft dysfunction (PGD) is the most common cause of early morbidity and mortality following lung transplant and is characterized by acute lung injury and capillary leak leading to an increase in extravascular lung water index (ELWI) and impaired graft function. PGD has many features in common with acute respiratory distress syndrome (ARDS). PGD may be life-threatening and can also lead to impaired long term lung function. In ARDS, a restrictive fluid strategy has been associated with an improvement in lung function and outcomes. Accurate methods of evaluating, quantifying and guiding the hemodynamic / fluid management and limiting the extent of ELWI that accumulates in the setting of PGD are lacking. Using transpulmonary thermodilution to estimate ELWI and the pulmonary permeability index (PPI) represents a novel approach to fluid management, which has been used in patients with ARDS, but to date not in the transplant setting. To determine if these measurements may better guide the management of lung transplant patients, the investigators first wish to establish whether these methods are able to predict the onset of clinical pulmonary edema earlier, whether they correlated with traditional markers of PGD, and whether they may be useful for predicting outcomes.
AIM 1: The investigators will evaluate the correlation between ELWI and current surrogates of pulmonary edema in lung transplant patients with and without Primary Graft Dysfunction (PGD)
AIM 2: The investigators will correlate the use of ELWI and PPI to determine the presence and severity of PGD.
AIM 3: a) The investigators will determine whether early measurements of ELWI and PPI can predict the onset of PGD.
- Across different strata of PGD, the investigators will determine whether ELWI and PPI have a differential effect on duration of mechanical ventilation.
The results of the study will be used for the following:
- Provide the rationale for routine monitoring of ELWI to detect PGD if found to be more discriminatory and have a stronger association with outcome compared to the current gold standard.
- Provide the means of early identification of those as risk of developing PGD in order to guide management decisions or future therapeutic interventions aimed at preventing or treating PGD.
- Provide the requisite groundwork for a clinical trial comparing the effects of an ELWI-driven protocol versus usual care on ICU outcomes in lung transplant recipients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing bilateral lung transplant for any indication will be considered to be enrolled in this study.
Key inclusion criteria (1 listed)
- All consecutive bilateral lung transplant recipients
Key exclusion criteria (2 listed)
- Immediate need for extracorporeal life support following transplant (those requiring ECLS four hours after intensive care admission can be included as the investigators would have obtained some ELWI measurements)
- Contraindications to femoral artery catheterization (eg, abdominal aortic aneurysm)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AIM 1: The presence of pulmonary edema on chest X ray (CXR) at 24 hours determined by blinded CXR reviewers
Time frame: 24 hours following lung transplant
On post operative day 1 (24 hours following lung transplant), the investigators will evaluate whether extravascular lung water measured at 24 hours correlates with pulmonary edema determined by reviewers of the CXR blinded to the extravascular lung water measurement. The investigators will use Pearson's correlation for normally distributed and Spearman's correlation for non-normally distributed values. A correlation coefficient of >0.8 will be considered a strong correlation
AIM 2: The presence of primary graft dysfunction at 24 hours determined by CXR evidence of bilateral airspace disease and Pa02/FiO2 ratio threshold by reviewers blinded to the extravascular lung water and pulmonary permeability measurements at 24
Time frame: 24 hours
24 hours following lung transplant, the investigators will evaluate whether the combination of extravascular lung water and pulmonary permeability measurements at 24 hours correlate with the presence and severity of primary graft dysfunction (PGD) at 24 hours. The median extravascular lung water and pulmonary permeability measurements will be calculated. The combinations of above/below median extravascular lung water with above/below median pulmonary permeability will be correlated to the presence of PGD. (eg. high ELWI + high PPI, high ELWI + low PPI, low ELWI + high PPI, low ELWI + low PPI) using Pearson's and Spearman's correlation where appropriate. Grade 0 PGD - Normal CXR AND a PaO2/FiO2 >300mmHg Grade 1 PGD - Bilateral airspace disease on CXR with AND a PaO2/FiO2 >300mmHg Grade 2 PGD - Bilateral airspace disease on CXR with AND a PaO2/FiO2 200-300mmHg Grade 3 PGD - Bilateral airspace disease on CXR with AND a PaO2/FiO2 <200mmHg.
AIM 3: The presence of primary graft dysfunction at 24 hours determined by CXR and Pa02/FiO2 ratio by reviewers blinded to early (time 0) extravascular lung water and pulmonary permeability measurements
Time frame: Time 0 extravascular lung water and pulmonary permeability measurements and primary graft dysfunction at 24 hours
The investigators will compare whether immediate (time 0) post operative measurements of the combination of extravascular lung water and pulmonary permeability can predict the later onset (24 hours) of primary graft dysfunction. The combinations of above/below median extravascular lung water with above/below median pulmonary permeability will be correlated to the presence of PGD. (eg. high ELWI + high PPI, high ELWI + low PPI, low ELWI + high PPI, low ELWI + low PPI) using logistic regression. Grade 0 PGD - Normal CXR AND a PaO2/FiO2 >300mmHg Grade 1 PGD - Bilateral airspace disease on CXR with AND a PaO2/FiO2 >300mmHg Grade 2 PGD - Bilateral airspace disease on CXR with AND a PaO2/FiO2 200-300mmHg Grade 3 PGD - Bilateral airspace disease on CXR with AND a PaO2/FiO2 <200mmHg.
5 secondary outcomes
AIM 1: The presence of pulmonary edema on chest X ray at 48 and 72 hours evaluated by CXR reviewers blinded to the extravascular lung water measurements measured at 48 and 72 hours
Time frame: 48 and 72 hours following lung transplant
AIM 2: The presence of late primary graft dysfunction determined by CXR and PaO2/FiO2 ratio evaluated by reviewers blinded to the extravascular lung water and pulmonary permeability measurements evaluated at 48 and 72 hours
Time frame: 48 and 72 hours following lung transplant
AIM 3: The presence of late primary graft dysfunction (48 and 72 hours) determined by CXR and PaO2/FiO2 ratio evaluated by reviewers blinded to the extravascular lung water and pulmonary permeability measurements at time 0
Time frame: Extravascular lung water and pulmonary permeability measurements at time 0 hours, primary graft dysfunction determination at 48 or 72 hours
AIM 3: The presence of any primary graft dysfunction determined by CXR and PaO2/FiO2 ratio (24, 48 or 72 hours) evaluated by reviewers blinded to the early extravascular lung water and pulmonary permeability measurements (6 hours and 12 hours)
Time frame: Extravascular lung water and pulmonary permeability measurements at 6 hours and 12 hours, any primary graft dysfunction determined at 24, 48 or 72 hours
AIM 3: Duration of mechanical ventilation
Time frame: Extravascular lung water and pulmonary permeability measurements at 24 hours, Hospital admission following lung transplant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Background: PubMed 17221189Monnet X, Anguel N, Osman D, Hamzaoui O, Richard C, Teboul JL. Assessing pulmonary permeability by transpulmonary thermodilution allows differentiation of hydrostatic pulmonary edema from ALI/ARDS. Intensive Care Med. 2007 Mar;33(3):448-53. doi: 10.1007/s00134-006-0498-6. Epub 2007 Jan 13.
- Background: PubMed 10784306Sakka SG, Ruhl CC, Pfeiffer UJ, Beale R, McLuckie A, Reinhart K, Meier-Hellmann A. Assessment of cardiac preload and extravascular lung water by single transpulmonary thermodilution. Intensive Care Med. 2000 Feb;26(2):180-7. doi: 10.1007/s001340050043.
- Background: PubMed 21187890Chung FT, Lin HC, Kuo CH, Yu CT, Chou CL, Lee KY, Kuo HP, Lin SM. Extravascular lung water correlates multiorgan dysfunction syndrome and mortality in sepsis. PLoS One. 2010 Dec 16;5(12):e15265. doi: 10.1371/journal.pone.0015265.
- Background: PubMed 12351254Della Rocca G, Costa GM, Coccia C, Pompei L, Di Marco P, Pietropaoli P. Preload index: pulmonary artery occlusion pressure versus intrathoracic blood volume monitoring during lung transplantation. Anesth Analg. 2002 Oct;95(4):835-43, table of contents. doi: 10.1097/00000539-200210000-00009.
- Background: PubMed 14605066Michard F, Alaya S, Zarka V, Bahloul M, Richard C, Teboul JL. Global end-diastolic volume as an indicator of cardiac preload in patients with septic shock. Chest. 2003 Nov;124(5):1900-8. doi: 10.1378/chest.124.5.1900.
- Background: PubMed 12475851Sakka SG, Klein M, Reinhart K, Meier-Hellmann A. Prognostic value of extravascular lung water in critically ill patients. Chest. 2002 Dec;122(6):2080-6. doi: 10.1378/chest.122.6.2080.
- Background: PubMed 10741952Hillinger S, Hoerstrup SP, Zollinger A, Weder W, Schmid RA, Stammberger U. A new model for the assessment of lung allograft ischemia/reperfusion injury. J Invest Surg. 2000 Jan-Feb;13(1):59-65. doi: 10.1080/089419300272267.
- Background: PubMed 12635057Rocca GD, Coccia C, Costa GM, Pompei L, Di Marco P, Pierconti F, Cappa M, Venuta F, Pietropaoli P. Is very early extubation after lung transplantation feasible? J Cardiothorac Vasc Anesth. 2003 Feb;17(1):29-35. doi: 10.1053/jcan.2003.6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Granton, MD, FRCPC principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Graft Dysfunction, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Granton, MD, FRCPC (416-340-4485, john.granton@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AIM 1: The presence of pulmonary edema on chest X ray (CXR) at 24 hours determined by blinded CXR reviewers (time frame: 24 hours following lung transplant). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01605214, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2018.