Cardiac ArrestQUOVADISNCT04129073
QUality Of Life and surviVAl in carDIac arreSt Patients
An observational study of Cardiac Arrest and Post-Anoxic Coma, run by Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva.
Trial 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 Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Cardiac Arrest, Post-Anoxic Coma, Central Nervous System Diseases
- What is being tested?
- Intensive care treatment
- How many people
- 1,600 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cardiac arrest patients admitted to ICU for specific care
Who may be able to join
- Age ≥ 14 years;
- Cardiac Arrest within 24 hours ICU admission
Who cannot join
- Absence of Informed consent;
- Age < 14 years
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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.
- Being tested
- Intensive care treatment
- Keywords
- Comparative Effectiveness Research
- Medical subject headings
- Heart Arrest, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive care treatmentOther
Intensive care treatment; Utilization of neuroprognostication tools
| Study group | Role | What they receive |
|---|---|---|
| Cardiac arrest patients admitted to Intensive Care treatment | Intensive Care treatment; Utilization of neuroprognostication tools Receives: Other: Intensive care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability
GOSe (Glascow Outcome Scale extended). Minimum value: 1 = Dead; Maximum value: 8= Upper Good Recovery
Measured: 6 months
Neurological Outcome
mRS (modified Ranking Scale) Minimum value: 0 = Complete recovery; Maximum value: 6 = Death
Measured: 6 months
Patients quality of life
EuroQoL-5D (european quality of life 5 dimensions). 0 = Worst imaginable health state; 100 = best imaginable health state
Measured: 12 months
Secondary outcomes (1)
Caregiver quality of life
Caregiver Burden Inventory. 0 to 20 = little or no burden; 61 to 88 = severe burden
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start1 Dec 2022 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergio Livigni, MD, Principal investigator, Ospedale San Giovanni Bosco, Turin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129073
- Sponsor's protocol ID
- QUO VADIS
- Acronym
- QUOVADIS
- Status last verified
- Mar 2022
- First submitted
- 11 Oct 2019
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QUO VADIS - QUality Of Life and surviVAl in carDIac arreSt Patients
- ClinicalTrials.gov ID
- NCT04129073
- Acronym / sponsor ID
- QUOVADIS / QUO VADIS
- Keywords
- Comparative Effectiveness Research
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Gruppo Italiano per la Valutazione degli Interventi in Terapia IntensivaUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 16 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac arrest patients admitted to Intensive Care treatment | – | Other: Intensive care treatmentIntensive Care treatment; Utilization of neuroprognostication tools |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cardiac arrest patients admitted to ICU for specific care
Key inclusion criteria (2 listed)
- Age ≥ 14 years;
- Cardiac Arrest within 24 hours ICU admission
Key exclusion criteria (2 listed)
- Absence of Informed consent;
- Age < 14 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive care treatmentIntensive care treatment; Utilization of neuroprognostication tools | Other | Cardiac arrest patients admitted to Intensive Care treatment |
Primary outcome
Disability
Time frame: 6 months
GOSe (Glascow Outcome Scale extended). Minimum value: 1 = Dead; Maximum value: 8= Upper Good Recovery
Neurological Outcome
Time frame: 6 months
mRS (modified Ranking Scale) Minimum value: 0 = Complete recovery; Maximum value: 6 = Death
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
1 secondary outcome
Caregiver quality of life
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- GiViTI websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sergio Livigni, MD principal investigator
Ospedale San Giovanni Bosco, Turin
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest and Post-Anoxic Coma, run by Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elena Garbero, MSc (+390354535388, giviti@marionegri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.