NCT04129073

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Dec 2022

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Dec 2022Nov 2026

First Submitted

Initial submission to the registry

October 11, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 16, 2019

Completed
3.1 years until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Expected
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

October 11, 2019

Last Update Submit

March 15, 2022

Conditions

Cardiac ArrestPost-Anoxic ComaCentral Nervous System Diseases

Keywords

Comparative Effectiveness Research

Outcome Measures

Primary Outcomes (3)

  • Disability

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

    6 months

  • Neurological Outcome

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

    6 months

  • Patients quality of life

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

    12 months

Secondary Outcomes (1)

  • Caregiver quality of life

    12 months

Study Arms (1)

Cardiac arrest patients admitted to Intensive Care treatment

Intensive Care treatment; Utilization of neuroprognostication tools

Other: Intensive care treatment

Interventions

Intensive care treatmentOTHER

Intensive care treatment; Utilization of neuroprognostication tools

Cardiac arrest patients admitted to Intensive Care treatment

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cardiac arrest patients admitted to ICU for specific care

You may qualify if:

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

You may not qualify if:

  • Absence of Informed consent;
  • Age \< 14 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Heart ArrestCentral Nervous System Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesNervous System Diseases

Study Officials

  • Sergio Livigni, MD

    Ospedale San Giovanni Bosco, Turin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Garbero, MSc

CONTACT

+390354535388giviti@marionegri.it

Alice Lavetti

CONTACT

+390354535313giviti@marionegri.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2019

First Posted

October 16, 2019

Study Start

December 1, 2022

Primary Completion

November 30, 2024

Study Completion (Estimated)

November 30, 2026

Last Updated

March 16, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share