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

Overview

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.

Detailed description

Specific aim 1: The aim is to develop an ECPR prognostication tool and validate its performance. In development, possible predictors for good neurological outcomes are prospectively gathered. The predictive ability of the predictors is tested in univariate and multivariable analysis, with the aim of improving patient selection for ECPR. Patients from the Gothenburg ECPR cohort are included in the development study. External validation with the ECMO patients from the Prague OHCA trial, following guidelines for validation studies, will follow, as well as external validation with further patients from Gothenburg.

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: A Long-term (1-12 years) follow-up of the ECPR patients will be performed, to determine the long-term neuropsychological outcomes.

4 A: Life satisfaction after ECPR will be assessed along with anxiety, depression, fatigue, cognitive function, and physical activity. The impact of these factors on life satisfaction will also be evaluated. QUALY will be calculated.

4 B: Long-term neurocognitive function in ECPR patients will be assessed through comprehensive neuropsychological testing, using conventional CPR patients from the TTM2 trial as a control group.

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

Interventions

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

Primary outcome measures

• Modified Rankin scale (MRs) [Time frame: 1 year]
• Performance of ECMO oxygenator function [Time frame: 0-60 days]
• Positive cultures of pre-primed ECMO circuits [Time frame: 0-90 days]
• Predictive ability of ERC neuro prognostication guidelines on ECPR patients [Time frame: 1 year]
• Life Satisfaction [Time frame: 1-12 years]
• Euro Qualy - 5 dimension (EQ-5D-5L) VAS [Time frame: 3 months to 12 years]
• Neurocognitive function [Time frame: 3 months to 12 years after the ECPR-treatment]
• Positive blood Cultures [Time frame: 1 month]

Secondary outcome measures (5)

• MoCA [Time frame: 3 months to 12 years after the ECPR treatment]
• Hospital Anxiety and Depression Scale (HADS) [Time frame: 3 months to 12 years]
• Mental Fatigue Scale [Time frame: 3 months to 12 years]
• modified Rankin Scale [Time frame: 3 months to 12 years]
• Actual physical activity [Time frame: 3 months to 12 years]

Eligibility criteria

Inclusion criteria

• ECMO-treated patients.

Exclusion criteria

• None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Sweden · 1 center

• Sahlgrenska Academy at Sahlgrenska University Hospital — Gothenburg

Publications

• Bengtsson D, Jonsson B, Redfors B. Sterility and oxygenator function in pre-primed extracorporeal membrane oxygenation: A prospective clinical study. Resusc Plus. 2024 Jun 5;19:100680. doi: 10.1016/j.resplu.2024.100680. eCollection 2024 Sep. PMID 38912528
• Redfors B, Byttner A, Bengtsson D, Watson P, Lannemyr L, Lundgren P, Gabel J, Rawshani A, Henningsson A. The Pre-ECPR Score: Developing and Validating a Multivariable Prediction Model for Favorable Neurological Outcomes in Patients Undergoing Extracorporeal Cardiopulmonary Resuscitation. J Cardiothorac Vasc Anesth. 2024 Dec;38(12):3018-3028. doi: 10.1053/j.jvca.2024.09.009. Epub 2024 Sep 17. PMID 39395854

Identifiers

NCT: NCT04198792 · GES

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗