QUality Of Life and surviVAl in carDIac arreSt Patients

Cardiac Arrest Clinical Trial

— QUOVADIS  

Official title:

QUO VADIS - QUality Of Life and surviVAl in carDIac arreSt Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04129073
• Other study ID #: QUO VADIS
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cardiac Arrest
• Central Nervous System Diseases
• Heart Arrest
• Nervous System Diseases
• Post-Anoxic Coma

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

External Links

•   GiViTI website