- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04129073
QUality Of Life and surviVAl in carDIac arreSt Patients (QUOVADIS)
QUO VADIS - QUality Of Life and surviVAl in carDIac arreSt Patients
Study Overview
Status
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Elena Garbero, MSc
- Phone Number: +390354535388
- Email: giviti@marionegri.it
Study Contact Backup
- Name: Alice Lavetti
- Phone Number: +390354535313
- Email: giviti@marionegri.it
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 14 years;
- Cardiac Arrest within 24 hours ICU admission
Exclusion Criteria:
- Absence of Informed consent;
- Age < 14 years
Study Plan
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
Investigators
- Principal Investigator: Sergio Livigni, MD, Ospedale San Giovanni Bosco, Turin
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- QUO VADIS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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