NCT04211207

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 26, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

January 27, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2022

Enrollment Period

3.5 years

First QC Date

December 17, 2019

Last Update Submit

November 28, 2023

Conditions

Keywords

Heart's respiratory quotientCardiac ArrestNon-invasive monitoringPoor prognosis

Outcome Measures

Primary Outcomes (1)

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

    Physiological parameter

    At 6 hours post intensive care unit admission

Secondary Outcomes (19)

  • Heart's respiratory value at intensive care unit admission to predict mortality

    At admission of intensive care unit

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

    At 12 hours post intensive care unit admission

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

    At 24 hours post intensive care unit admission

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

    At admission of intensive care unit

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

    At 6 hours post intensive care unit admission

  • +14 more secondary outcomes

Interventions

heart's respiratory quotient as non invasive monitoring value

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Grenoble Alpes

Grenoble, 38043, France

Location

Related Publications (21)

  • 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.

    PMID: 29684654BACKGROUND
  • 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.

    PMID: 22622403BACKGROUND
  • 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.

    PMID: 27555170BACKGROUND
  • 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.

    PMID: 27987396BACKGROUND
  • 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.

    PMID: 23942856BACKGROUND
  • 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.

    PMID: 30819234BACKGROUND
  • 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.

    PMID: 28986863BACKGROUND
  • 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.

    PMID: 15342971BACKGROUND
  • 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.

    PMID: 26112759BACKGROUND
  • 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.

    PMID: 21597442BACKGROUND
  • 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.

    PMID: 21177882BACKGROUND
  • 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.

    PMID: 1446489BACKGROUND
  • 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.

    PMID: 19217200BACKGROUND
  • 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.

    PMID: 21068697BACKGROUND
  • 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.

    PMID: 26855893BACKGROUND
  • Solberg G, Robstad B, Skjonsberg OH, Borchsenius F. Respiratory gas exchange indices for estimating the anaerobic threshold. J Sports Sci Med. 2005 Mar 1;4(1):29-36. eCollection 2005 Mar 1.

    PMID: 24431958BACKGROUND
  • Mekontso-Dessap A, Castelain V, Anguel N, Bahloul M, Schauvliege F, Richard C, Teboul JL. Combination of venoarterial PCO2 difference with arteriovenous O2 content difference to detect anaerobic metabolism in patients. Intensive Care Med. 2002 Mar;28(3):272-7. doi: 10.1007/s00134-002-1215-8. Epub 2002 Feb 8.

    PMID: 11904655BACKGROUND
  • Mukai A, Suehiro K, Kimura A, Funai Y, Matsuura T, Tanaka K, Yamada T, Mori T, Nishikawa K. Comparison of the venous-arterial CO2 to arterial-venous O2 content difference ratio with the venous-arterial CO2 gradient for the predictability of adverse outcomes after cardiac surgery. J Clin Monit Comput. 2020 Feb;34(1):41-53. doi: 10.1007/s10877-019-00286-z. Epub 2019 Feb 22.

    PMID: 30796642BACKGROUND
  • Piot J, Hebrard A, Durand M, Payen JF, Albaladejo P. An elevated respiratory quotient predicts complications after cardiac surgery under extracorporeal circulation: an observational pilot study. J Clin Monit Comput. 2019 Feb;33(1):145-153. doi: 10.1007/s10877-018-0137-0. Epub 2018 Apr 17.

    PMID: 29667097BACKGROUND
  • Shinozaki K, Becker LB, Saeki K, Kim J, Yin T, Da T, Lampe JW. Dissociated Oxygen Consumption and Carbon Dioxide Production in the Post-Cardiac Arrest Rat: A Novel Metabolic Phenotype. J Am Heart Assoc. 2018 Jun 29;7(13):e007721. doi: 10.1161/JAHA.117.007721.

    PMID: 29959138BACKGROUND
  • Uber A, Grossestreuer AV, Ross CE, Patel PV, Trehan A, Donnino MW, Berg KM. Preliminary observations in systemic oxygen consumption during targeted temperature management after cardiac arrest. Resuscitation. 2018 Jun;127:89-94. doi: 10.1016/j.resuscitation.2018.04.001. Epub 2018 Apr 4.

    PMID: 29626611BACKGROUND

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2019

First Posted

December 26, 2019

Study Start

January 27, 2020

Primary Completion

July 31, 2023

Study Completion

September 22, 2023

Last Updated

November 29, 2023

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations