The EXCEL Registry of Patients Requiring ECMO
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03793257 |
|
Recruitment Status :
Recruiting
First Posted : January 4, 2019
Last Update Posted : March 10, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease |
|---|
| Critically Ill Acute Respiratory Failure Acute Heart Failure Cardiac Arrest |
The aim of EXCEL is to generate a bi-national multidisciplinary network of integrated care for patients suffering acute cardiac or respiratory failure or cardiac arrest requiring extracorporeal membrane oxygenation (ECMO) to monitor long term outcomes and identify best practice.
Each year around 130,000 Australians and New Zealanders are admitted to an intensive care unit (ICU). The sickest patients in the ICU who have severe failure of the heart or lungs may require an external machine to oxygenate their blood in addition to a mechanical ventilator. This intervention, called extracorporeal membrane oxygenation (ECMO), involves circulating all of the patient's blood through large cannulae to external machinery every minute. It has the capability of completely replacing a non-functioning heart or lungs for days to weeks on end. These critically ill patients who require ECMO are the sickest in the hospital with only 42% hospital survival. The use of ECMO has doubled in Australia and New Zealand and globally over five years, and in the USA has increased by 433%.
The use of ECMO is associated with significant costs and risks, and it requires specialist training and expertise. In order to prepare for the organisation of these complex interventions in the ICU across regions, the investigators need to have accurate data on patients undergoing ECMO. The investigators monitor and review current practice in ECMO services by providing robust binational registry data to service providers and clinicians with a closed-loop feedback system. EXCEL explores barriers and enablers to evidence-based care in ECMO services and providing a platform to embed clinical trials. The investigators will translate findings with greater capacity, reach, and impact to drive measureable change in practice and improve patient-centred outcomes.
The EXCEL Partnership represents a novel, coordinated effort to create a high-quality, detailed, prospective registry of patients requiring ECMO at ECMO centres. A tailored, detailed ECMO registry (EXCEL) can be used to address specific safety concerns, clinical questions and process of care issues. As a result, EXCEL can be designed and implemented to answer new investigator-initiated, hypothesis-driven clinical questions.
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 2000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 12 Months |
| Official Title: | The EXCEL Registry: A Comprehensive Binational Registry on the Treatment and Outcomes of Patients Requiring ECMO |
| Actual Study Start Date : | February 1, 2019 |
| Estimated Primary Completion Date : | December 22, 2023 |
| Estimated Study Completion Date : | December 20, 2024 |
- Disability-free survival at 6 months, defined as alive and free of disability, measured with the World Health Organisation's Disability Assessment Schedule (WHODAS 2.0) score of <25%. [ Time Frame: At 6 months from study enrolment ]WHODAS 2.0 measured using a trained, blinded assessor via telephone interview. The WHODAS scores are calculated using the sum of the six domain scores. These domain scores are then converted to a metric score ranging from 0 to 100 (where 0= no disability; 100= full disability)
- Number of participants with adverse events including major bleeding up to 28 days after ECMO, infection, thrombosis (in the ECMO cannulae or in the patient) and limb ischaemia [ Time Frame: Up to 28 days after ECMO initiation ]All adverse events are recorded determined by treating clinician
- Healthcare utilization -caseload per centre [ Time Frame: Up to 12 months from study enrolment ]ECMO patient numbers (caseload per centre)
- Healthcare utilization - ECMO initiation timing [ Time Frame: Up to 12 months from study enrolment ]Timing of ECMO initiation by staff including an ECMO retrieval team
- Healthcare utilization - Number of staff members required to manage ECMO [ Time Frame: Up to 12 months from study enrolment ]Staff numbers required for the provision of ECMO in ICU and the training required for these staff members to perform their role.
- Healthcare utilization - hospital length of stay [ Time Frame: Up to 12 months from study enrolment ]Hospital and in-patient rehabilitation length of stay including hospital readmissions and time spent in ICU
- Healthcare costs [ Time Frame: Measured from ECMO commencement to hospital discharge until 6 months following hopsital admission. ]Number of resources including staff and, equipment and blood products utilised whilst the patient was receiving hospital care until 6 months following hospital admission.
- Health-related quality of life at baseline, 6 and 12 months using the EQ5D-5L [ Time Frame: At 6 and 12 months from study enrolment. Retrospective baseline measured at 6 months. ]Measured using the EQ5D-5L, delivered by a trained, blinded assessor via telephone interview. The EQ5D includes an analogue scale that asks the patient to rate their health on a scale of 0 to 100. (Where 0= worst health imaginable; 100= best health imaginable)
- Number of patients with disability at 6 and 12 months [ Time Frame: At 6 and 12 months from study enrolment ]Measured using the WHODAS 2.0, delivered by a trained, blinded assessor via telephone interview
- Psychological function at 12 months [ Time Frame: At 12 months from study enrolment ]Measured using the EQ5D-5L, delivered by a trained, blinded assessor via telephone interview
- Return to work at 6 months [ Time Frame: At 6 months from study enrolment ]Return to work measured bu the WHODAS 2.0, delivered by a trained, blinded assessor via telephone interview
- Disability at baseline, 6 and 12 months [ Time Frame: Measured at 6 and 12 months. Retrospective baseline disability measured at 6 months. ]Patient reported disability using a disability scale, delivered by a trained, blinded assessor via telephone interview
- Activities of daily living at 6 and 12 months [ Time Frame: Measured at 6 and 12 months ]Activities of daily living measured at 6 and 12 month using the ADL and IADL, delivered by a trained, blinded assessor via telephone interview
- Cognitive function at 12 months [ Time Frame: Measured at 12 months ]Cognitive function measured at 12 months using the MOCA Blind, delivered by a trained, blinded assessor via telephone interview
- Number patients who survive to 12 months following ECMO initiation [ Time Frame: At 12 months from study enrolment ]Measured by Research Coordinators at each of the participating sites
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients admitted to ICU and receive ECMO in Australia and New Zealand
- Patients aged 18 years or older
Nil Exclusion Criteria:
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03793257
| Contact: Carol L Hodgson, PhD | +613 9903 0598 | carol.hodgson@monash.edu | |
| Contact: Ben Fulcher | +613 9903 0930 | bentley.fulcher@monash.edu |
Show 31 study locations
| Study Chair: | Carol L Hodgson, PhD | Australian and New Zealand Intensive Care Research Centre |
| Responsible Party: | Australian and New Zealand Intensive Care Research Centre |
| ClinicalTrials.gov Identifier: | NCT03793257 |
| Other Study ID Numbers: |
ANZIC-RC/CH003 |
| First Posted: | January 4, 2019 Key Record Dates |
| Last Update Posted: | March 10, 2022 |
| Last Verified: | March 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Intensive Care Critical Care Extracorporeal Membrane Oxygenation Extracorporeal Life Support |
|
Respiratory Insufficiency Critical Illness Disease Attributes |
Pathologic Processes Respiration Disorders Respiratory Tract Diseases |