Cardiac Arrest Clinical Trial
Official title:
Predictors for Survival and Good Neurological Outcome in E-CPR and Non CPR Treated Patients
NCT number | NCT04198792 |
Other study ID # | GES |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2010 |
Est. completion date | January 1, 2030 |
In ECPR, where CPR times often range from 30 to 120 minutes, only patients with good circulation during CPR survive, while non-survivors commonly suffer from anoxic brain injury. The selection process during CPR is challenging causing a general survival rate of just 2 out of 10, and the urgent need for better selection criteria has been emphasized. It it crucial to keep cardiac arrest times as short as possible, pre primed-ECMO can facilitate this. The ECMO treatment and the long CPR times of ECPR can also affect the measurements of the neurologic prognostication guidelines after cardiac arrest, making its validity uncertain in this specific cohort. Further, the long-term neuropsychological follow-up is limited to a few patients, making it uncertain if ECPR gives the survivors good long-term life satisfaction or just a prolonged life. Our overall aim is to optimize and improve the care pathway for ECPR patients by refining patient selection, assessing pre-primed ECMO, validating neurological prognostication guidelines, and understanding long-term outcomes and challenges faced by survivors. Specific Aim 1: Evaluating predictors for good neurological outcomes in ECPR and to develop an evidence-based selection tool for ECPR. Specific aim 2: To assess the sterility and function of pre-primed ECMO. Specific aim 3: To evaluate the applicability of current guidelines for neurological prognostication after cardiac arrest in ECPR patients, and to assess the predictive value of individual and combined neurological tests in this specific patient population. Specific aim 4: To determine the long-term neuropsychological outcomes, identify the problems survivors experience in daily life, and assess life satisfaction - by comprehensive follow-up visits with validated questionnaires and neuropsychology testing up to 10 years after the ECMO-treated cardiac arrest
Status | Recruiting |
Enrollment | 300 |
Est. completion date | January 1, 2030 |
Est. primary completion date | January 1, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: - ECMO-treated patients att Sahlgrenska University Hospital Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
Sweden | Sahlgrenska Akademy at Sahlgrenska University Hospital | Gothenburg |
Lead Sponsor | Collaborator |
---|---|
Sahlgrenska University Hospital, Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cost | The in hospital cost of the treatment for the patients, in Swedish kronor. | 3 month | |
Primary | Survival with Cerebral Performance Category 1 or 2. | Good neurological outcome in ECPR-patients | 1 year | |
Primary | Physicians Global Assessment to measure quality of life | Quality of Life in survivors after ECPR and ECMO without cardiac arrest, Measured with in depth interviews | 1-15 years | |
Primary | Positive blood Cultures | Infection rates in ECMO-patients | 1 month | |
Primary | Euro Qualy - 5 dimension (EQ-5D) | Assesment of quality of life | 1-7 years | |
Primary | Cerebral Performance Scale (CPC) | Assessment of cerebral performance. 1-5, where 1-2 is considered good outcome | 1-7 years | |
Primary | Modified Rankin scale (MRs) | Assessmenty of cognitive function. 0-6, where 0 is best. | 1-7 years | |
Primary | Trailmaking test | Assessmenty of cognitive function. Shorter time is better. | 1-7 years | |
Primary | Short Form -36 (SF-36) | Quality of life. 8 scaled scores from 0-100, where 100 is best. | 1-7 years | |
Primary | New York heart association class (NYHA class) | Assessment of physical function.1-4, where 1 is best | 1-7 years | |
Primary | Positive cultures of pre-primed ECMO circuits | ECMO circuits is pre-primed and cultures taken at the start of ECMO treatment | 0-90 days | |
Primary | Performance of ECMO oxygenator function | Oxygenator resistance, and the needed FiO2 and sweep gas flow will be assessed | 0-60 days | |
Primary | Predictive ability of ERC neuro prognostication guidelines on ECPR patients | Diagnostic performance and ROC analysis of individual and total ERC predictors on outcome in ECPR | 1 year |
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