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Cardiac ArrestQUANTICNCT04211207

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

An observational study of Cardiac Arrest, run by University Hospital, Grenoble at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Arrest
What is being tested?
non invasive monitoring value
How many people
40 participants
Where
1 siteFrance
Study dates
27 Jan 2020to 22 Sep 2023
Phase
Observational
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients presenting to the ICU for cardiac arrest will be recruited into the study according the inclusion /non inclusion criteria, The patient should be inclued according the investigtor decision, and the non-opposition of patient's relatives was asked as soon as possible. the eligible patient will be enrolled in the study and post cardiac arrest standard care was applied, Implementation of the calorimetry module for the constants collection. data collection was during the first 24 hours. When the patient wakes up: information and collection of his non-opposition was asked. The vital status will be collected at 30 day and neurological prognosis evaluation defined by the CPC scorewill be collected at 90 ± 7j by telephone contact.

Who may be able to join

  • 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

Who cannot join

  • Pregnancy
  • Prior neurological impairment
  • Persons deprived of their liberty by a judicial proceeding, or administrative decision.

Trial locations and contacts

1 site in 1 country.

France1 site
  • Chu Grenoble Alpes

    Grenoble, 38043

Other trials in France

About this study

Official title: Evaluation of the Heart's Respiratory Quotient as Predictive Value After Extra-hospital

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.

Conditions
Cardiac Arrest
Being tested
non invasive monitoring value
Keywords
Heart's respiratory quotient, Cardiac Arrest, Non-invasive monitoring, Poor prognosis
Medical subject headings
Heart Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • non invasive monitoring valueOther

    heart's respiratory quotient as non invasive monitoring value

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heart's respiratory value at H6 post intensive care unit admission to predict mortality

    Physiological parameter

    Measured: At 6 hours post intensive care unit admission

Secondary outcomes (19)
  1. Heart's respiratory value at intensive care unit admission to predict mortality

    Physiological parameter

    Measured: At admission of intensive care unit

  2. Heart's respiratory value at H12 post intensive care unit admission to predict mortality

    Physiological parameter

    Measured: At 12 hours post intensive care unit admission

  3. Heart's respiratory value at H24 post intensive care unit admission to predict mortality

    Physiological parameter

    Measured: At 24 hours post intensive care unit admission

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

    Physiological parameter

    Measured: At admission of intensive care unit

  5. Heart's respiratory value at H6 post intensive care unit admission to predict neurological prognosis

    Physiological parameter

    Measured: At 6 hours post intensive care unit admission

  6. Heart's respiratory value at H12 post intensive care unit admission to predict neurological prognosis

    Physiological parameter

    Measured: At 12 hours post intensive care unit admission

  7. Heart's respiratory value at H24 post intensive care unit admission to predict neurological prognosis

    Physiological parameter

    Measured: At 24 hours post intensive care unit admission

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

    Metabolic parameters

    Measured: At admission of intensive care unit

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

    Metabolic parameters

    Measured: At 6 hours post intensive care unit admission

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

    Metabolic parameters

    Measured: At 12 hours post intensive care unit admission

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

    Metabolic parameters

    Measured: At 24 hours post intensive care unit admission

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

    Metabolic parameters

    Measured: At admission of intensive care unit

  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

    Metabolic parameters

    Measured: At 6 hours post intensive care unit admission

  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

    Metabolic parameters

    Measured: At 12 hours post intensive care unit admission

  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

    Metabolic parameters

    Measured: At 24 hours post intensive care unit admission

  16. Cardiac arrest circumstances following Utstein-style guidelines according mortality

    Metabolic parameters

    Measured: At admission of intensive care unit

  17. Cardiac arrest circumstances following Utstein-style guidelines according neurological prognosis

    Cardiac arrest circumstances

    Measured: At admission of intensive care unit

  18. Vital status at day 30

    Alive or Dead status

    Measured: At 30 Days post intensive car unit admission

  19. Cerebral performance category (CPC) score at day 90

    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.

    Measured: At 90 Days post intensive car unit admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2019
  2. Study start27 Jan 2020
  3. Primary completion31 Jul 2023
  4. Study completion22 Sep 2023

Resources

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
Case only
Time perspective
Prospective
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04211207
Sponsor's protocol ID
38RC19.296
Other IDs
2019-A02548-49
Acronym
QUANTIC
Status last verified
Nov 2022
First submitted
17 Dec 2019
Last updated
29 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Luc G, Baert V, Escutnaire J, Genin M, Vilhelm C, Di Pompeo C, Khoury CE, Segal N, Wiel E, Adnet F, Tazarourte K, Gueugniaud PY, Hubert H; On behalf GR-ReAC. Epidemiology of out-of-hospital cardiac arrest: A French national incidence and mid-term survival rate study. Anaesth Crit Care Pain Med. 2019 Apr;38(2):131-135. doi: 10.1016/j.accpm.2018.04.006. Epub 2018 Apr 21.

    PubMed 29684654
  • Horburger D, Testori C, Sterz F, Herkner H, Krizanac D, Uray T, Schober A, Stockl M, Stratil P, Weiser C, Wallmuller C, Holzer M. Mild therapeutic hypothermia improves outcomes compared with normothermia in cardiac-arrest patients--a retrospective chart review. Crit Care Med. 2012 Aug;40(8):2315-9. doi: 10.1097/CCM.0b013e31825333cf.

    PubMed 22622403
  • Bhattacharjee S, Baidya DK, Maitra S. Therapeutic hypothermia after cardiac arrest is not associated with favorable neurological outcome: a meta-analysis. J Clin Anesth. 2016 Sep;33:225-32. doi: 10.1016/j.jclinane.2016.03.001. Epub 2016 May 5.

    PubMed 27555170
  • Adnet F, Triba MN, Borron SW, Lapostolle F, Hubert H, Gueugniaud PY, Escutnaire J, Guenin A, Hoogvorst A, Marbeuf-Gueye C, Reuter PG, Javaud N, Vicaut E, Chevret S. Cardiopulmonary resuscitation duration and survival in out-of-hospital cardiac arrest patients. Resuscitation. 2017 Feb;111:74-81. doi: 10.1016/j.resuscitation.2016.11.024. Epub 2016 Dec 14.

    PubMed 27987396
  • Lemiale V, Dumas F, Mongardon N, Giovanetti O, Charpentier J, Chiche JD, Carli P, Mira JP, Nolan J, Cariou A. Intensive care unit mortality after cardiac arrest: the relative contribution of shock and brain injury in a large cohort. Intensive Care Med. 2013 Nov;39(11):1972-80. doi: 10.1007/s00134-013-3043-4. Epub 2013 Aug 14.

    PubMed 23942856
  • Pekkarinen PT, Backlund M, Efendijev I, Raj R, Folger D, Litonius E, Laitio R, Bendel S, Hoppu S, Ala-Kokko T, Reinikainen M, Skrifvars MB. Association of extracerebral organ failure with 1-year survival and healthcare-associated costs after cardiac arrest: an observational database study. Crit Care. 2019 Feb 28;23(1):67. doi: 10.1186/s13054-019-2359-z.

    PubMed 30819234
  • Dell'Anna AM, Sandroni C, Lamanna I, Belloni I, Donadello K, Creteur J, Vincent JL, Taccone FS. Prognostic implications of blood lactate concentrations after cardiac arrest: a retrospective study. Ann Intensive Care. 2017 Oct 6;7(1):101. doi: 10.1186/s13613-017-0321-2.

    PubMed 28986863
  • Kliegel A, Losert H, Sterz F, Holzer M, Zeiner A, Havel C, Laggner AN. Serial lactate determinations for prediction of outcome after cardiac arrest. Medicine (Baltimore). 2004 Sep;83(5):274-279. doi: 10.1097/01.md.0000141098.46118.4c.

    PubMed 15342971
  • Riveiro DF, Oliveira VM, Braunner JS, Vieira SR. Evaluation of Serum Lactate, Central Venous Saturation, and Venous-Arterial Carbon Dioxide Difference in the Prediction of Mortality in Postcardiac Arrest Syndrome. J Intensive Care Med. 2016 Sep;31(8):544-52. doi: 10.1177/0885066615592865. Epub 2015 Jun 24.

    PubMed 26112759
  • Cocchi MN, Miller J, Hunziker S, Carney E, Salciccioli J, Farris S, Joyce N, Zimetbaum P, Howell MD, Donnino MW. The association of lactate and vasopressor need for mortality prediction in survivors of cardiac arrest. Minerva Anestesiol. 2011 Nov;77(11):1063-71. Epub 2011 May 11.

    PubMed 21597442
  • Walley KR. Use of central venous oxygen saturation to guide therapy. Am J Respir Crit Care Med. 2011 Sep 1;184(5):514-20. doi: 10.1164/rccm.201010-1584CI.

    PubMed 21177882
  • Rivers EP, Rady MY, Martin GB, Fenn NM, Smithline HA, Alexander ME, Nowak RM. Venous hyperoxia after cardiac arrest. Characterization of a defect in systemic oxygen utilization. Chest. 1992 Dec;102(6):1787-93. doi: 10.1378/chest.102.6.1787.

    PubMed 1446489
  • Gaieski DF, Band RA, Abella BS, Neumar RW, Fuchs BD, Kolansky DM, Merchant RM, Carr BG, Becker LB, Maguire C, Klair A, Hylton J, Goyal M. Early goal-directed hemodynamic optimization combined with therapeutic hypothermia in comatose survivors of out-of-hospital cardiac arrest. Resuscitation. 2009 Apr;80(4):418-24. doi: 10.1016/j.resuscitation.2008.12.015. Epub 2009 Feb 12.

    PubMed 19217200
  • Walters EL, Morawski K, Dorotta I, Ramsingh D, Lumen K, Bland D, Clem K, Nguyen HB. Implementation of a post-cardiac arrest care bundle including therapeutic hypothermia and hemodynamic optimization in comatose patients with return of spontaneous circulation after out-of-hospital cardiac arrest: a feasibility study. Shock. 2011 Apr;35(4):360-6. doi: 10.1097/SHK.0b013e318204c106.

    PubMed 21068697
  • Mallat J, Lemyze M, Tronchon L, Vallet B, Thevenin D. Use of venous-to-arterial carbon dioxide tension difference to guide resuscitation therapy in septic shock. World J Crit Care Med. 2016 Feb 4;5(1):47-56. doi: 10.5492/wjccm.v5.i1.47. eCollection 2016 Feb 4.

    PubMed 26855893

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Arrest, run by University Hospital, Grenoble at 1 site in France.

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 4 inclusion and 3 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: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart's respiratory value at H6 post intensive care unit admission to predict mortality (time frame: At 6 hours post intensive care unit admission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04211207, which also lists 21 linked publications.

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 29 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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