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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04211207
Other study ID # 38RC19.296
Secondary ID 2019-A02548-49
Status Completed
Phase
First received
Last updated
Start date January 27, 2020
Est. completion date September 22, 2023

Study information

Verified date November 2022
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date September 22, 2023
Est. primary completion date July 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
non invasive monitoring value
heart's respiratory quotient as non invasive monitoring value

Locations

Country Name City State
France Chu Grenoble Alpes Grenoble

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (21)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 21 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Heart's respiratory value at intensive care unit admission to predict mortality Physiological parameter At admission of intensive care unit
Secondary Heart's respiratory value at H12 post intensive care unit admission to predict mortality Physiological parameter At 12 hours post intensive care unit admission
Secondary Heart's respiratory value at H24 post intensive care unit admission to predict mortality Physiological parameter At 24 hours post intensive care unit admission
Secondary Heart's respiratory value at intensive care unit admission to predict neurological prognosis Physiological parameter At admission of intensive care unit
Secondary Heart's respiratory value at H6 post intensive care unit admission to predict neurological prognosis Physiological parameter At 6 hours post intensive care unit admission
Secondary Heart's respiratory value at H12 post intensive care unit admission to predict neurological prognosis Physiological parameter At 12 hours post intensive care unit admission
Secondary Heart's respiratory value at H24 post intensive care unit admission to predict neurological prognosis Physiological parameter At 24 hours post intensive care unit admission
Secondary metabolic parameters ( lactate, Oxygen consummation, carbon dioxide production and central venous oxygen saturation) to predict mortality at intensive care unit admission Metabolic parameters At admission of intensive care unit
Secondary 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 At 6 hours post intensive care unit admission
Secondary 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 At 12 hours post intensive care unit admission
Secondary 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 At 24 hours post intensive care unit admission
Secondary Metabolic parameters ( lactate, Oxygen consummation, carbon dioxide production and central venous oxygen saturation) to predict neurological prognosis at intensive care unit admission Metabolic parameters At admission of intensive care unit
Secondary 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 At 6 hours post intensive care unit admission
Secondary 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 At 12 hours post intensive care unit admission
Secondary 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 At 24 hours post intensive care unit admission
Secondary Cardiac arrest circumstances following Utstein-style guidelines according mortality Metabolic parameters At admission of intensive care unit
Secondary Cardiac arrest circumstances following Utstein-style guidelines according neurological prognosis Cardiac arrest circumstances At admission of intensive care unit
Secondary Vital status at day 30 Alive or Dead status At 30 Days post intensive car unit admission
Secondary 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. At 90 Days post intensive car unit admission
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