Clinical trial NCT04859270: The Holistic Health Care of Post-Cardiac Arrest Survivors: From Patient's Health to Family Resilience
Official title: The Holistic Health Care of Post-Cardiac Arrest Survivors: From Patient's Health to Family Resilience
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post-Cardiac Arrest Syndrome
Keywords: Post-cardiac arrest
Holistic care
Family resilience
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The primary participants of the study are patients with out-of-hospital cardiac arrest and achieved return of spontaneous circulation after cardiopulmonary resuscitation. The number of primary participants is 200, and the interviewees are patients and their family members (400), a total of 600 participants.

Brief summary: Post-cardiac arrest mortality remains high and proper care after cardiopulmonary resuscitation is an important clinical challenge. This prospective observational cohort aims to (1) identify the factors that affect short-term and long-term survival in post-cardiac arrest survivors and (2) investigate the patients and their families' health-related quality of life and psychological well-being.

Detailed description: For this cohort study, adult survivors (≧20 years) of sudden cardiac arrest for more than 5 minutes after cardiopulmonary resuscitation will be enrolled. Basic demographic information, clinical events throughout hospitalization, and laboratory examination results will be recorded. Patients will be assessed for their neurological outcome using Glasgow coma score (GCS) and cerebral performance categories (CPC) upon hospital discharge, 1, 3, 6, and 12 months after discharge.

Post-cardiac arrest care is clinically challenging and this study aims to evaluate not just the physical well-being but also the psychological well-being of these patients on the short-term and long-term survival. Patients and their families will be assessed on their health-related quality of life and psychological well-being upon hospital discharge using the following scales: Mayo-Portland Adaptability Inventory (MPAI-4), World Health Organization Quality of Life Scale (WHOQOL-BREF), Impact of Event Scale - Revised (IES-R), and Family Resilience Framework. They will also be followed for one year after discharge at 1, 3, 6, and 12 months.

Data will be analyzed using the SPSS and SAS package. Odds ratios and hazards ratios will be determined for the factors that affect survival after cardiac arrest. The findings will help clinicians provide timely support to the patients and their families to promote physical and psychological well-being, and integrate them back to society as soon as possible.

Eligibility criteria: Inclusion Criteria:

1. Patients with non-traumatic cardiac arrest, who have successfully sustained return of spontaneous circulation for more than five minutes after resuscitation efforts.

Exclusion Criteria:

1. Under 20 years of age
2. Pregnant
3. Terminally ill cancer patients or cancer patients who are unwilling to receive treatment
4. When the ICU is over capacity and unable to provide intensive care.
5. The patient or family members refused to participate in this study.

Primary outcomes:
measure: Post-cardiac arrest survival
timeFrame: Up to 1 year after discharge
measure: Neurological outcome - GCS
timeFrame: Up to 1 year after discharge
measure: Neurological outcome - CPC
timeFrame: Up to 1 year after discharge
measure: Functional outcome
timeFrame: Up to 1 year after discharge
measure: Life quality
timeFrame: Up to 1 year after discharge
measure: Emotional stress
timeFrame: Up to 1 year after discharge
measure: Family resilience
timeFrame: Up to 1 year after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Min-Shan Tsai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: