QUOVADIS: QUality Of Life and surviVAl in carDIac arreSt Patients

Sponsor
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04129073
Collaborator
(none)
1,600
48

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Intensive care 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 Design

Study Type:
Observational
Anticipated Enrollment :
1600 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
QUO VADIS - QUality Of Life and surviVAl in carDIac arreSt Patients
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Nov 30, 2024
Anticipated Study Completion Date :
Nov 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Cardiac arrest patients admitted to Intensive Care treatment

Intensive Care treatment; Utilization of neuroprognostication tools

Other: Intensive care treatment
Intensive care treatment; Utilization of neuroprognostication tools

Outcome Measures

Primary Outcome Measures

  1. Disability [6 months]

    GOSe (Glascow Outcome Scale extended). Minimum value: 1 = Dead; Maximum value: 8= Upper Good Recovery

  2. Neurological Outcome [6 months]

    mRS (modified Ranking Scale) Minimum value: 0 = Complete recovery; Maximum value: 6 = Death

  3. Patients quality of life [12 months]

    EuroQoL-5D (european quality of life 5 dimensions). 0 = Worst imaginable health state; 100 = best imaginable health state

Secondary Outcome Measures

  1. Caregiver quality of life [12 months]

    Caregiver Burden Inventory. 0 to 20 = little or no burden; 61 to 88 = severe burden

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age ≥ 14 years;

  • Cardiac Arrest within 24 hours ICU admission

Exclusion Criteria:
  • Absence of Informed consent;

  • Age < 14 years

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
ClinicalTrials.gov Identifier:
NCT04129073
Other Study ID Numbers:
  • QUO VADIS
First Posted:
Oct 16, 2019
Last Update Posted:
Mar 16, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2022