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

Recruiting

• Conditions: Extracorporeal Membrane Oxygenation; Hypoxia-Ischemia, Brain; Cardiac Arrest
• Interventions: Other: No intervention

• Registration Number: NCT04198792
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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.

Study Timeline

• Study Start: 2010-01-01
• Study First Submitted: 2019-11-18
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-13
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21
• Primary Completion: 2030-01-01
• Study Completion: 2030-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• ECMO-treated patients att Sahlgrenska University Hospital

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ECPR patients	No intervention	Patients that is put om ECMO during cardiac arrest
ECMO patients, non-ECPR	No intervention	Patients that is put on ECMO due to circulatory failure but not cardiac arrest

Primary Outcome Measures

Name	Time	Method
Physicians Global Assessment to measure quality of life	1-15 years	Quality of Life in survivors after ECPR and ECMO without cardiac arrest, Measured with in depth interviews
Survival with Cerebral Performance Category 1 or 2.	1 year	Good neurological outcome in ECPR-patients
Positive blood Cultures	1 month	Infection rates in ECMO-patients
Cerebral Performance Scale (CPC)	1-7 years	Assessment of cerebral performance. 1-5, where 1-2 is considered good outcome
Trailmaking test	1-7 years	Assessmenty of cognitive function. Shorter time is better.
Modified Rankin scale (MRs)	1-7 years	Assessmenty of cognitive function. 0-6, where 0 is best.
Positive cultures of pre-primed ECMO circuits	0-90 days	ECMO circuits is pre-primed and cultures taken at the start of ECMO treatment
Performance of ECMO oxygenator function	0-60 days	Oxygenator resistance, and the needed FiO2 and sweep gas flow will be assessed
Euro Qualy - 5 dimension (EQ-5D)	1-7 years	Assesment of quality of life
New York heart association class (NYHA class)	1-7 years	Assessment of physical function.1-4, where 1 is best
Predictive ability of ERC neuro prognostication guidelines on ECPR patients	1 year	Diagnostic performance and ROC analysis of individual and total ERC predictors on outcome in ECPR
Short Form -36 (SF-36)	1-7 years	Quality of life. 8 scaled scores from 0-100, where 100 is best.

Trial Locations

Locations (1)

Sahlgrenska Akademy at Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden