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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04129073
Other study ID # QUO VADIS
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 1, 2022
Est. completion date November 30, 2026

Study information

Verified date March 2022
Source Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
Contact Elena Garbero, MSc
Phone +390354535388
Email giviti@marionegri.it
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1600
Est. completion date November 30, 2026
Est. primary completion date November 30, 2024
Accepts healthy volunteers No
Gender All
Age group 14 Years and older
Eligibility Inclusion Criteria: - Age = 14 years; - Cardiac Arrest within 24 hours ICU admission Exclusion Criteria: - Absence of Informed consent; - Age < 14 years

Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva

Outcome

Type Measure Description Time frame Safety issue
Primary Disability GOSe (Glascow Outcome Scale extended). Minimum value: 1 = Dead; Maximum value: 8= Upper Good Recovery 6 months
Primary Neurological Outcome mRS (modified Ranking Scale) Minimum value: 0 = Complete recovery; Maximum value: 6 = Death 6 months
Primary 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 Caregiver quality of life Caregiver Burden Inventory. 0 to 20 = little or no burden; 61 to 88 = severe burden 12 months
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