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Recruiting NCT04859270

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

Observational Post-Cardiac Arrest Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Post-Cardiac Arrest Syndrome. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Post-cardiac arrest survival [Time frame: Up to 1 year after discharge]
  • Neurological outcome - GCS [Time frame: Up to 1 year after discharge]
  • Neurological outcome - CPC [Time frame: Up to 1 year after discharge]
  • Functional outcome [Time frame: Up to 1 year after discharge]
  • Life quality [Time frame: Up to 1 year after discharge]
  • Emotional stress [Time frame: Up to 1 year after discharge]
  • Family resilience [Time frame: Up to 1 year after discharge]

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

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

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

Taiwan · 1 center
  • National Taiwan University Hospital — Taipei

Identifiers

NCT: NCT04859270 · 202012242RINB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗