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QUANTIC: Evaluation of the Heart's Respiratory Quotient as Predictive Value After Extra-hospital Cardiac Arrest

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Recruiting
CT.gov ID
NCT04211207
Collaborator
(none)
80
Enrollment
1
Location
31.1
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

It has been shown that elevation of the heart's respiratory quotient after cardiac surgery is predictive of the complications occurrence. In addition, a high heart's respiratory quotient is predictive of anaerobic metabolism after cardiac surgery. In the wake of cardiorespiratory arrest, the presence of anaerobic metabolism reflected by hyperlactatemia is an important prognostic factor. However, this monitoring is invasive and discontinuous. The hypothesis of the study is to show that a rise in the respiratory quotient by a non-invasive monitoring is a factor of poor prognosis in the wake of a Cardiac Arrest.

Condition or Disease Intervention/Treatment Phase
  • Other: non invasive monitoring value

Study Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Evaluation of the Heart's Respiratory Quotient as Predictive Value After Extra-hospital
Actual Study Start Date :
Jan 27, 2020
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Heart's respiratory value at H6 post intensive care unit admission to predict mortality [At 6 hours post intensive care unit admission]

    Physiological parameter

Secondary Outcome Measures

  1. Heart's respiratory value at intensive care unit admission to predict mortality [At admission of intensive care unit]

    Physiological parameter

  2. Heart's respiratory value at H12 post intensive care unit admission to predict mortality [At 12 hours post intensive care unit admission]

    Physiological parameter

  3. Heart's respiratory value at H24 post intensive care unit admission to predict mortality [At 24 hours post intensive care unit admission]

    Physiological parameter

  4. Heart's respiratory value at intensive care unit admission to predict neurological prognosis [At admission of intensive care unit]

    Physiological parameter

  5. Heart's respiratory value at H6 post intensive care unit admission to predict neurological prognosis [At 6 hours post intensive care unit admission]

    Physiological parameter

  6. Heart's respiratory value at H12 post intensive care unit admission to predict neurological prognosis [At 12 hours post intensive care unit admission]

    Physiological parameter

  7. Heart's respiratory value at H24 post intensive care unit admission to predict neurological prognosis [At 24 hours post intensive care unit admission]

    Physiological parameter

  8. metabolic parameters ( lactate, Oxygen consummation, carbon dioxide production and central venous oxygen saturation) to predict mortality at intensive care unit admission [At admission of intensive care unit]

    Metabolic parameters

  9. metabolic parameters ( lactate, Oxygen consummation, carbon dioxide production and central venous oxygen saturation) to predict mortality at H6 post intensive care unit admission [At 6 hours post intensive care unit admission]

    Metabolic parameters

  10. Metabolic parameters ( lactate, Oxygen consummation, carbon dioxide production and central venous oxygen saturation) to predict mortality at H12 post intensive care unit admission [At 12 hours post intensive care unit admission]

    Metabolic parameters

  11. Metabolic parameters ( lactate, Oxygen consummation, carbon dioxide production and central venous oxygen saturation) to predict mortality at H24 post intensive care unit admission [At 24 hours post intensive care unit admission]

    Metabolic parameters

  12. Metabolic parameters ( lactate, Oxygen consummation, carbon dioxide production and central venous oxygen saturation) to predict neurological prognosis at intensive care unit admission [At admission of intensive care unit]

    Metabolic parameters

  13. Metabolic parameters ( lactate, Oxygen consummation, carbon dioxide production and central venous oxygen saturation) to predict neurological prognosis at H6 post intensive care unit admission [At 6 hours post intensive care unit admission]

    Metabolic parameters

  14. Metabolic parameters ( lactate, Oxygen consummation, carbon dioxide production and central venous oxygen saturation) to predict neurological prognosis at H12 post intensive care unit admission [At 12 hours post intensive care unit admission]

    Metabolic parameters

  15. Metabolic parameters ( lactate, Oxygen consummation, carbon dioxide production and central venous oxygen saturation) to predict neurological prognosis at H24 post intensive care unit admission [At 24 hours post intensive care unit admission]

    Metabolic parameters

  16. Cardiac arrest circumstances following Utstein-style guidelines according mortality [At admission of intensive care unit]

    Metabolic parameters

  17. Cardiac arrest circumstances following Utstein-style guidelines according neurological prognosis [At admission of intensive care unit]

    Cardiac arrest circumstances

  18. Vital status at day 30 [At 30 Days post intensive car unit admission]

    Alive or Dead status

  19. Cerebral performance category (CPC) score at day 90 [At 90 Days post intensive car unit admission]

    Cerebral performance category (CPC) score : CPC=1 : Conscious, alert, and oriented with normal cognitive functions, CPC=2 : Conscious and alert with moderate cerebral disability; CPC=3: Conscious with severe disability; CPC=4: Comatose or in persistent vegetative state; CPC=5 : Certified brain death or dead by traditional criteria.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Adult >18 years

  • Admission to intensive care unit after a non-hospital cardiopulmonary arrest.

  • Resumption of spontaneous cardiac activity.

  • Non-opposition of the patient or his relatives

Exclusion Criteria:

  • Pregnancy

  • Prior neurological impairment

  • Persons deprived of their liberty by a judicial proceeding, or administrative decision.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Grenoble Alpes Grenoble France 38043

Sponsors and Collaborators

  • University Hospital, Grenoble

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT04211207
Other Study ID Numbers:
  • 38RC19.296
  • 2019-A02548-49
First Posted:
Dec 26, 2019
Last Update Posted:
Sep 29, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Grenoble
Heart's respiratory quotient
Cardiac Arrest
Non-invasive monitoring
Poor prognosis
Additional relevant MeSH terms:
Heart Arrest

Study Results

No Results Posted as of Sep 29, 2021