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

Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04198792
• Other study ID #: GES
• Status: Recruiting
• Start date: January 1, 2010
• Est. completion date: January 1, 2030

Study information

• Verified date: May 2024
• Source: Sahlgrenska University Hospital, Sweden
• Contact: Bengt Redfors, MD, PhD
• Phone: +46768445402
• Email: bengt.redfors[@]vgregion.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Brain Ischemia
• Cardiac Arrest
• Extracorporeal Membrane Oxygenation
• Hypoxia
• Hypoxia-Ischemia, Brain

Intervention

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

Locations

Country	Name	City	State
Sweden	Sahlgrenska Akademy at Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

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