Routine Versus Selective Intraoperative ECMO in Lung Transplant

NCT05505422 | Completed

• 1 other identifier: 2023-10663
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplant; Complications; Extracorporeal Circulation; Complications; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Study recruitment rate

  6 months after the onset of study

Secondary Outcomes (6)

• Percentage of patients loss to follow-up

  1 year

• 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.

  14 days

• Incidence of all-cause mortality at 30 days, 90 days, and one year

  1 year

• Incidence of postoperative stroke / cerebrovascular accident

  14 days

• Incidence of an Early major postoperative neurologic complication (EMPNC): This includes stroke, severe encephalopathy, and severe seizures diagnosed within 14 days after surgery.

  14 days

Other Outcomes (13)

• Incidence and grade of primary graft dysfunction (PGD) at 0, 24, 48, and 72 hours

  From the end of surgery up to 72 hours after surgery

• Incidence of postoperative bleeding complications. The definition of bleeding complication is based on Bleeding Academic Research Consortium (BARC) classification

  14 days after surgery

• Intraoperative blood product transfusion requirements

  From the beginning of surgery to transfer to the intensive care unit

Study Arms (2)

On demand ECMO (study group)

EXPERIMENTAL

Device: On demand ECMO

Routine ECMO (control group)

ACTIVE COMPARATOR

Device: Routine ECMO

Interventions

Routine ECMO DEVICE

Routine ECMO during lung tansplant

Routine ECMO (control group)

On demand ECMO DEVICE

Selective, indication-based intraoperative cardiopulmonary support. In this group, the transplant will be planned without cardiopulmonary support. intraoperative ECMO will be used selectively based on hemodynamic and/or gas exchange abnormalities : 1. Inability to maintain adequate hemodynamics and stable perfusion or oxygenation during surgery 2. Prolonged high dose pressor required to maintain adequate perfusion 3. A sustained drop in cerebral saturation \> 25% of baseline despite initial attempts at optimization 4. Inability to tolerate pulmonary artery clamping 5. Inadequate gas exchange despite attempts at the optimization of ventilator parameters and treatments related to respiratory mechanics and ventilation/perfusion matching 6. Inadequate exposure to the surgical field

On demand ECMO (study group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Inability to provide consent for the study or patient refusal
• Retransplantation
• Multi-organ transplantation
• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X3E4, Canada

Location

Related Publications (1)

• Nasir BS, Weatherald J, Ramsay T, Cypel M, Donahoe L, Durkin C, Schisler T, Nagendran J, Liberman M, Landry C, Overbeek C, Moore A, Ferraro P. Randomized trial of routine versus on-demand intraoperative extracorporeal membrane oxygenation in lung transplantation: A feasibility study. J Heart Lung Transplant. 2024 Jun;43(6):1005-1009. doi: 10.1016/j.healun.2024.02.1454. Epub 2024 Feb 28.

  PMID: 38423414 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Basil Nasir, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 17, 2022
• Study Start: September 15, 2022
• Primary Completion: March 15, 2023
• Study Completion: December 15, 2023
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)