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NCT Number: NCT04129073

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

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Absence of Informed consent;
  • Age < 14 years

Treatment and study plan

Intensive care treatment

Other

Intensive care treatment; Utilization of neuroprognostication tools

Primary outcomes

  1. Disability

    Time frame: 6 months

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

  2. Neurological Outcome

    Time frame: 6 months

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

  3. 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

Secondary outcomes

  1. Caregiver quality of life

    Time frame: 12 months

    Caregiver Burden Inventory. 0 to 20 = little or no burden; 61 to 88 = severe burden

Study contacts

Contact information is provided by the study sponsor or research team.

Alice Lavetti

CONTACT

[email protected]

+390354535313

Elena Garbero, MSc

CONTACT

[email protected]

+390354535388

Sponsors and collaborators

Lead sponsor

Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva

Other

Registry information

Official study title

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

Acronym: QUOVADIS

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Oct 16, 2019
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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