Clinical trial NCT05505422: Routine Versus Selective Intraoperative ECMO in Lung Transplant
Official title: Randomized Trial of Routine Versus Selective Use of Intraoperative Extracorporeal Mechanical Support During Lung Transplantation : a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Transplant; Complications
Extracorporeal Circulation; Complications
Postoperative Complications
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Intraoperative hemodynamic management is vital in the success of lung transplantation. Significant intraoperative hemodynamic compromise and hypoxic episodes may contribute to an increase in severe postoperative complications related to hypoperfusion, including cerebrovascular accidents, acute kidney injury, and mesenteric ischemia. In certain lung transplant recipients, intraoperative cardiopulmonary support is mandatory because certain factors would make "off-pump" transplants unsafe. These include severe pulmonary hypertension or severe ventricular dysfunction. In such patients, routine intraoperative support should be employed. However, it is possible to conduct the lung transplant without cardiopulmonary support in the remainder of patients who do not have severe pulmonary hypertension or right heart dysfunction. In such patients, the lung transplant may be started without cardiopulmonary support. However, cardiopulmonary support may be initiated "on-demand" if there is development or impending hemodynamic embarrassment or hypoxia. Conversely, the opposite approach would be to routinely conduct all lung transplant operations using cardiopulmonary support, which may also lead to specific ECMO-related complications.

The investigators question whether on demand intraoperative ECMO in patients with significant risk factors will produce severe postoperative complications in a rate similar to routine ECMO.

Detailed description: Hypothesis: In patients where cardiopulmonary bypass (CPB) / ECMO is not mandatory, on-demand use of intra-operative ECMO is equivalent to routine use for patients undergoing lung transplant.

The study will be a prospective, randomized controlled trial. The investigators seek to compare outcomes of two different strategies of cardiopulmonary support during lung transplantation; routine support with ECMO versus selective (on-demand), indication- based support with ECMO. The allocation ratio will be 1:1. A multi-center trial is necessary to allow for a sufficient sample size. However, the investigators believe a pilot study is essential to determine feasibility before embarking on such a significant undertaking.

In this preliminary pilot study, recruitment will be limited to lung transplant patients at the Centre hospitalier de l'Universite de Montreal (CHUM). The primary purpose of the pilot study will be to define recruitment ability and assess the feasibility of conducting the study. Depending on the results of this pilot study, the next step would be to expand the study to multiple lung transplant centers to achieve an adequate sample size and power, allowing the investigators to answer the question of interest.

Eligibility criteria: Inclusion Criteria:

Patients undergoing lung transplant surgery during the study period (6 months)

Exclusion Criteria:

1. Inability to provide consent for the study or patient refusal
2. Retransplantation
3. Multi-organ transplantation
4. Lung transplant recipients where intraoperative support is mandatory and "off- pump" transplant would be unsafe:

   a. Severe pulmonary hypertension (PH):

   i. Systolic pulmonary artery pressure (PAP) ≥ 80 mm Hg on echocardiography, right heart catheterization, or pulmonary artery catheter measurement

   ii. Mean PAP ≥ 55 mm Hg on echocardiography, right heart catheterization, or pulmonary artery catheter measurement

   iii. The ratio of mean pulmonary to systemic artery pressure of more than 0.66

   b. Moderate to severe right ventricular (RV) hypokinesis or dysfunction

   c. Left ventricular dysfunction: Defined as ejection fraction (LVEF) \< 50% on echocardiography, ventriculography, computed tomography (CT), or magnetic resonance imaging (MRI)

   d. Significant coronary artery disease (CAD)requiring stenting or surgical grafting

Primary outcomes:
measure: Study recruitment rate
timeFrame: 6 months after the onset of study
Secondary outcomes:
measure: Percentage of patients loss to follow-up
timeFrame: 1 year
measure: The composite incidence of death, disabling stroke, grade 2 or 3 primary graft dysfunction at 72 hours, major bleeding (BARC grade 3a, 3b or 5), vascular complications, or stage II or III acute kidney injury at 14 days.
timeFrame: 14 days
measure: Incidence of all-cause mortality at 30 days, 90 days, and one year
timeFrame: 1 year
measure: Incidence of postoperative stroke / cerebrovascular accident
timeFrame: 14 days
measure: Incidence of an Early major postoperative neurologic complication (EMPNC): This includes stroke, severe encephalopathy, and severe seizures diagnosed within 14 days after surgery.
timeFrame: 14 days
measure: Incidence of severe postoperative complications. This is defined as Clavien-Dindo grade III complication or greater
timeFrame: 14 days
Other outcomes:
measure: Incidence and grade of primary graft dysfunction (PGD) at 0, 24, 48, and 72 hours
timeFrame: From the end of surgery up to 72 hours after surgery
measure: Incidence of postoperative bleeding complications. The definition of bleeding complication is based on Bleeding Academic Research Consortium (BARC) classification
timeFrame: 14 days after surgery
measure: Intraoperative blood product transfusion requirements
timeFrame: From the beginning of surgery to transfer to the intensive care unit
measure: Perioperative blood product transfusion requirements
timeFrame: 14 days
measure: Intensive care unit and hospital length of stay in days
timeFrame: Beginning from the arrival to the intensive care unit immediately after surgery
measure: Duration of mechanical ventilation in hours
timeFrame: Beginning from the arrival to the intensive care unit immediately after surgery, up to about 30 days
measure: Incidence of re-intubation
timeFrame: 14 days
measure: Incidence of postoperative tracheostomy
timeFrame: 21 days
measure: Incidence of acute kidney injury (AKI) within 14 days. The definition of AKI is based on Kidney Disease; improving global outcomes (KDIGO) classification
timeFrame: 14 days
measure: Incidence of vascular complications
timeFrame: 14 days
measure: Forced expiratory volume at 1 second (FEV1) at 1 year
timeFrame: 1 year
measure: Incidence of stroke
timeFrame: 1 year
measure: Incidence of acute rejection episodes
timeFrame: 1 year
Locations:
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Basil Nasir, MD
role: PRINCIPAL_INVESTIGATOR
References: