Clinical trial NCT04198792: Predictors for Survival and Good Neurological Outcome in E-CPR and Non CPR Treated Patients
Official title: Predictors for Survival and Good Neurological Outcome in E-CPR and Non CPR Treated Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Arrest
Extracorporeal Membrane Oxygenation
Hypoxia-Ischemia, Brain
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 300
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ECPR Group: Patients who is put on ECMO during cardiac arrest. ECMO Group: Patients who is put on ECMO with some ongoing circulaiton

Brief summary: 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

Detailed description: Specific aim 1: Patients from the Gothenburg ECPR cohort are included in the study. Possible predictors for good neurological outcomes are prospectively gathered. The predictive ability of the predictors for good neurological outcome is tested in univariate and multivariable analysis, with the aim of improving patient selection for ECPR.

Specific aim 2: Cardiohelp ECMO circuits are set up dry, followed by wet-priming and used in the ECMO treatments of the centre. The circuits are cultured at ECMO-initiation and the incidence of positive cultures is assessed. The effect of the pre-primed time on ECMO function is also assessed.

Specific aim 3: The predictive ability of the current guideline for neurological prognostication of comatose patients in the ICU after cardiac arrest, from the European Resuscitation Council, is assessed in the ECPR cohort of Gothenburg. The diagnostic performance of individual predictors as well as the total accuracy of the prediction will be assessed.

Specific aim 4: Long-term follow-up will be assessed for the ECPR patients, to determine the long-term neuropsychological outcomes, identify the problems survivors experience in daily life, and assess life satisfaction. QUALY will be calculated.

The general ECMO population from 2004 of the center is included as a control group and positive cultures during their ECMO runs are documented.

Eligibility criteria: Inclusion Criteria:

* ECMO-treated patients att Sahlgrenska University Hospital

Exclusion Criteria:

* None

Primary outcomes:
measure: Survival with Cerebral Performance Category 1 or 2.
timeFrame: 1 year
measure: Physicians Global Assessment to measure quality of life
timeFrame: 1-15 years
measure: Positive blood Cultures
timeFrame: 1 month
measure: Euro Qualy - 5 dimension (EQ-5D)
timeFrame: 1-7 years
measure: Cerebral Performance Scale (CPC)
timeFrame: 1-7 years
measure: Modified Rankin scale (MRs)
timeFrame: 1-7 years
measure: Trailmaking test
timeFrame: 1-7 years
measure: Short Form -36 (SF-36)
timeFrame: 1-7 years
measure: New York heart association class (NYHA class)
timeFrame: 1-7 years
measure: Positive cultures of pre-primed ECMO circuits
timeFrame: 0-90 days
measure: Performance of ECMO oxygenator function
timeFrame: 0-60 days
measure: Predictive ability of ERC neuro prognostication guidelines on ECPR patients
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
measure: Cost
timeFrame: 3 month
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska Akademy at Sahlgrenska University Hospital
Study officials:
affiliation: The Sahlgrenska Academy ar Sahlgrenska University Hospital, Gorhenburg, Sweden
name: Bengt Redfors, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: