- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04211207
Evaluation of the Heart's Respiratory Quotient as Predictive Value After Extra-hospital Cardiac Arrest (QUANTIC)
Evaluation of the Heart's Respiratory Quotient as Predictive Value After Extra-hospital
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: DURAND MICHEL, Doctor
- Phone Number: 00334 76 76 75 75
- Email: MDURAND@chu-grenoble.fr
Study Locations
-
-
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Grenoble, France, 38043
- Chu Grenoble Alpes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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.
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart's respiratory value at H6 post intensive care unit admission to predict mortality
Time Frame: At 6 hours post intensive care unit admission
|
Physiological parameter
|
At 6 hours post intensive care unit admission
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart's respiratory value at intensive care unit admission to predict mortality
Time Frame: At admission of intensive care unit
|
Physiological parameter
|
At admission of intensive care unit
|
Heart's respiratory value at H12 post intensive care unit admission to predict mortality
Time Frame: At 12 hours post intensive care unit admission
|
Physiological parameter
|
At 12 hours post intensive care unit admission
|
Heart's respiratory value at H24 post intensive care unit admission to predict mortality
Time Frame: At 24 hours post intensive care unit admission
|
Physiological parameter
|
At 24 hours post intensive care unit admission
|
Heart's respiratory value at intensive care unit admission to predict neurological prognosis
Time Frame: At admission of intensive care unit
|
Physiological parameter
|
At admission of intensive care unit
|
Heart's respiratory value at H6 post intensive care unit admission to predict neurological prognosis
Time Frame: At 6 hours post intensive care unit admission
|
Physiological parameter
|
At 6 hours post intensive care unit admission
|
Heart's respiratory value at H12 post intensive care unit admission to predict neurological prognosis
Time Frame: At 12 hours post intensive care unit admission
|
Physiological parameter
|
At 12 hours post intensive care unit admission
|
Heart's respiratory value at H24 post intensive care unit admission to predict neurological prognosis
Time Frame: At 24 hours post intensive care unit admission
|
Physiological parameter
|
At 24 hours post intensive care unit admission
|
metabolic parameters ( lactate, Oxygen consummation, carbon dioxide production and central venous oxygen saturation) to predict mortality at intensive care unit admission
Time Frame: At admission of intensive care unit
|
Metabolic parameters
|
At admission of intensive care unit
|
metabolic parameters ( lactate, Oxygen consummation, carbon dioxide production and central venous oxygen saturation) to predict mortality at H6 post intensive care unit admission
Time Frame: At 6 hours post intensive care unit admission
|
Metabolic parameters
|
At 6 hours post intensive care unit admission
|
Metabolic parameters ( lactate, Oxygen consummation, carbon dioxide production and central venous oxygen saturation) to predict mortality at H12 post intensive care unit admission
Time Frame: At 12 hours post intensive care unit admission
|
Metabolic parameters
|
At 12 hours post intensive care unit admission
|
Metabolic parameters ( lactate, Oxygen consummation, carbon dioxide production and central venous oxygen saturation) to predict mortality at H24 post intensive care unit admission
Time Frame: At 24 hours post intensive care unit admission
|
Metabolic parameters
|
At 24 hours post intensive care unit admission
|
Metabolic parameters ( lactate, Oxygen consummation, carbon dioxide production and central venous oxygen saturation) to predict neurological prognosis at intensive care unit admission
Time Frame: At admission of intensive care unit
|
Metabolic parameters
|
At admission of intensive care unit
|
Metabolic parameters ( lactate, Oxygen consummation, carbon dioxide production and central venous oxygen saturation) to predict neurological prognosis at H6 post intensive care unit admission
Time Frame: At 6 hours post intensive care unit admission
|
Metabolic parameters
|
At 6 hours post intensive care unit admission
|
Metabolic parameters ( lactate, Oxygen consummation, carbon dioxide production and central venous oxygen saturation) to predict neurological prognosis at H12 post intensive care unit admission
Time Frame: At 12 hours post intensive care unit admission
|
Metabolic parameters
|
At 12 hours post intensive care unit admission
|
Metabolic parameters ( lactate, Oxygen consummation, carbon dioxide production and central venous oxygen saturation) to predict neurological prognosis at H24 post intensive care unit admission
Time Frame: At 24 hours post intensive care unit admission
|
Metabolic parameters
|
At 24 hours post intensive care unit admission
|
Cardiac arrest circumstances following Utstein-style guidelines according mortality
Time Frame: At admission of intensive care unit
|
Metabolic parameters
|
At admission of intensive care unit
|
Cardiac arrest circumstances following Utstein-style guidelines according neurological prognosis
Time Frame: At admission of intensive care unit
|
Cardiac arrest circumstances
|
At admission of intensive care unit
|
Vital status at day 30
Time Frame: At 30 Days post intensive car unit admission
|
Alive or Dead status
|
At 30 Days post intensive car unit admission
|
Cerebral performance category (CPC) score at day 90
Time Frame: 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.
|
At 90 Days post intensive car unit admission
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC19.296
- 2019-A02548-49 (Other Identifier: ID RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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