The Holistic Health Care of Post-Cardiac Arrest Survivors: From Patient's Health to Family Resilience

Post-Cardiac Arrest Syndrome Clinical Trial

Official title:

The Holistic Health Care of Post-Cardiac Arrest Survivors: From Patient's Health to Family Resilience

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04859270
• Other study ID #: 202012242RINB
• Status: Recruiting
• Start date: April 12, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: National Taiwan University Hospital
• Contact: Min-Shan Tsai, MD, PhD
• Phone: 886-2-23562831
• Email: mshanmshan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2024
• Est. primary completion date: July 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Arrest
• Post-Cardiac Arrest Syndrome

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-cardiac arrest survival	Post-cardiac arrest survival after cardiopulmonary resuscitation	Up to 1 year after discharge
Primary	Neurological outcome - GCS	Using the Glasgow Coma Scale (GCS) of the patients, with scores ranging from 3 to 15, and higher scores indicating a better outcome.	Up to 1 year after discharge
Primary	Neurological outcome - CPC	Cerebral performance categories (CPC) of the patients, with categories 1 and 2 as favorable outcomes, and categories 3 to 5 as unfavorable outcomes	Up to 1 year after discharge
Primary	Functional outcome	Self-reported assessment using the Mayo-Portland Adaptability Index (MPAI-4) for the patients. This is a 29-item scale with overall scores ranging from 0 to 111, and lower scores indicating a better outcome and greater community reintegration post-injury.	Up to 1 year after discharge
Primary	Life quality	Self-reported assessment using the abbreviated World Health Organization Quality of Life questionnaire (WHOQOL-BREF) for the patients. This is a 26-item scale with overall transformed scores ranging from 0 to 100, and higher scores indicating a better quality of life.	Up to 1 year after discharge
Primary	Emotional stress	Self-reported assessment using the Impact of Events Scale - Revised (IES-R) for the patients. This is a 22-item scale with scores ranging from 0 to 88, and higher scores indicating more subjective distress.	Up to 1 year after discharge
Primary	Family resilience	Self-reported assessment using the Family Resilience Framework scale for the patients and their families. This is a 31-item scale with scores ranging from 0 to 155, and higher scores indicating a higher level of resilience.	Up to 1 year after discharge