Predictors for Survival and Good Neurological Outcome in E-CPR and Non CPR Treated Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorSahlgrenska University Hospital

About this trial

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 and validate (internally and externally) 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 12 years after the ECMO-treated cardiac arrest.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ECMO-treated patients.

Disqualifiers

None

Trial population

ECPR Group: Patients who is put on ECMO during cardiac arrest. ECMO Group: Patients who is put on ECMO with some ongoing circulaiton

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

    No intervention, but ECPR patients will be compared to ECMO-patients that have not had cardiac arrest

Treatment groups

700 Participants
are divided into 2 treatment groups
Group A: ECPR patients1 intervention
Group B: ECMO patients, non-ECPR1 intervention

Trial outcomes

Primary outcomes

1

Modified Rankin scale (MRs)

Assessmenty of cognitive function. 0-6, where 0 is best.

Time frame
1 year
2

Performance of ECMO oxygenator function

Oxygenator resistance, and the needed FiO2 and sweep gas flow will be assessed

Time frame
0-60 days
3

Positive cultures of pre-primed ECMO circuits

ECMO circuits is pre-primed and cultures taken at the start of ECMO treatment

Time frame
0-90 days
4

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

Time frame
1 year

Secondary outcomes

1

MoCA

Assess cognitive function, higher is better. 0-30 where higher is better

Time frame
3 months to 12 years after the ECPR treatment
2

Hospital Anxiety and Depression Scale (HADS)

Two sub scales 0-21 which assess anxiety and depression, higer is worse

Time frame
3 months to 12 years
3

Mental Fatigue Scale

Assess fatigue 0-42 points. Higher is worse

Time frame
3 months to 12 years
4

modified Rankin Scale

physical function from 0-6 where 0 is best

Time frame
3 months to 12 years

Other outcomes

1

Cost

The in hospital cost of the treatment for the patients, in Swedish kronor.

Time frame
3 month
2

Short Form -36 (SF-36)

Quality of life. 8 scaled scores from 0-100, where 100 is best.

Time frame
1-7 years
3

Trailmaking test

Assessmenty of cognitive function. Shorter time is better.

Time frame
1-7 years
4

New York heart association class (NYHA class)

Assessment of physical function.1-4, where 1 is best

Time frame
1-7 years

Sponsors and contacts

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