QUality Of Life and surviVAl in carDIac arreSt Patients (QUOVADIS)

QUO VADIS - QUality Of Life and surviVAl in carDIac arreSt Patients

QUO VADIS is a national observational study with the aim to describe clinical intervention and utilization of neuroprognostication tools in the management of patients admitted to ICU following cardiac arrest

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Detailed Description

Despite recent improvements in post-resuscitation care, about 50% of patients resuscitated from cardiac arrest die or have poor neurological prognosis. Post-anoxic brain injury is common after cardiac arrest and is a major cause of post-resuscitation mortality. Since there has been a significant investment in improving the emergency response to both in-hospital ad out-of-hospital cardiac arrest (IHCA and OHCA, respectevly) patients and reported improvements in short-term survival outcomes, the long-term neurological state and quality of life of survivors and their caregiver is of growing significance.

QUO VADIS is a national observational study created to describe clinical interventions and utilization of neuroprognostication tools in the management of patients admitted to ICU following cardiac arrest.

The aims of the study are:

  • To create an Italian Registry that describes clinical interventions and neuroprognostication tools used in the management of patients admitted to ICU following cardiac arrest
  • To evaluate, after one year from the cardiac arrest, the neurological outcome and the quality of life of the patients;
  • To evaluate, after one year from the cardiac arrest, the quality of life of caregivers;
  • To identify the most effective clinical intervention in the management of post-cardiac arrest patients admitted to ICU;
  • To create a prognostic model for patients admitted to ICU after cardiac arrest.

Study Type

Observational

Enrollment (Anticipated)

1600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cardiac arrest patients admitted to ICU for specific care

Description

Inclusion Criteria:

  • Age ≥ 14 years;
  • Cardiac Arrest within 24 hours ICU admission

Exclusion Criteria:

  • Absence of Informed consent;
  • Age < 14 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cardiac arrest patients admitted to Intensive Care treatment
Intensive Care treatment; Utilization of neuroprognostication tools
Intensive care treatment; Utilization of neuroprognostication tools

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability
Time Frame: 6 months
GOSe (Glascow Outcome Scale extended). Minimum value: 1 = Dead; Maximum value: 8= Upper Good Recovery
6 months
Neurological Outcome
Time Frame: 6 months
mRS (modified Ranking Scale) Minimum value: 0 = Complete recovery; Maximum value: 6 = Death
6 months
Patients quality of life
Time Frame: 12 months
EuroQoL-5D (european quality of life 5 dimensions). 0 = Worst imaginable health state; 100 = best imaginable health state
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver quality of life
Time Frame: 12 months
Caregiver Burden Inventory. 0 to 20 = little or no burden; 61 to 88 = severe burden
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sergio Livigni, MD, Ospedale San Giovanni Bosco, Turin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2022

Primary Completion (Anticipated)

November 30, 2024

Study Completion (Anticipated)

November 30, 2026

Study Registration Dates

First Submitted

October 11, 2019

First Submitted That Met QC Criteria

October 14, 2019

First Posted (Actual)

October 16, 2019

Study Record Updates

Last Update Posted (Actual)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 15, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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