Predictive and Prognostic Value of Cellular Dysoxia Markers After Cardiac Surgery With Extracorporeal Circulation

NCT03107572 | Completed

• 3 other identifiers: NI_2016IRB 00010254 --2016-030DEC2015-136
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

The study consist of evaluation in cardiac surgery with cardiopulmonary bypass (CPB) setting the ability of PCO2 derived variables (ΔPCO2, ΔPCO2/C(a-v)O2 ratio), compared to lactate and ScVO2 to predict major postoperative adverse events.

Conditions

Cardiac Surgery; Cardiopulmonary Bypass; Microcirculation; Tissue Oxygenation; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Performances of PCO2 derived perfusion markers (ΔPCO2 and ΔPCO2/C(a-v)O2 ratio) measured 2 hours after CPB to predict major postoperative adverse events (MPAE) in the 48 hours following cardiac surgery.

  Composite outcome defined as: * Acute kidney injury (AKI) with KDIGO score of 2 or more * Acute myocardial infarction according to the universal definition of acute myocardial ischemia * ARDS according to Berlin definition or respiratory failure (P/F ratio \< 300 mmHg + need of mechanical ventilation) * Stroke or generalized seizure * Cardiogenic or distributive shock defined as hypotension (SAP \<90 mmHg, MAP\< 65 mmHg) and reduced of cardiac index, ejection fraction or worsening of previously known reduce cardiac index or ejection fraction. * Revision surgery * Hemorrhagic shock * Death

  First 2 days after surgery

Secondary Outcomes (4)

• Performances of PCO2 derived perfusion marker measured ICU admission, 6 and 24 hours after CPB to predict major postoperative adverse events (MPAE) in the 2 and 7 days following cardiac surgery.

  2 and 7 days following cardiac surgery

• Performances of PCO2 derived perfusion marker measured ICU admission, 6 and 24 hours after CPB to predict organ failure (any organ failure with specific SOFA of 2 or more) in the 2 and 7 days after surgery.

  2 and 7 days following surgery

• Kinetics and relation of PCO2 derived variables, lactate and ScVO2 in the 24 hours following surgery.

  24 hours following surgery

• Association of CO2 derived variables with lactate clearance, vasopressive score and outcome variables (ICU and hospital length of stay, ICU and hospital mortality).

  24 hours following surgery

Other Outcomes (2)

• Relation of thenar StO2 with vascular occlusion test derived variables and cellular dysorexia and perfusion markers, and their predictive value in postoperative complication after cardiac surgery.

  2 and 7 days following surgery

• Association of PCO2 derived variables, lactate, ScVO2, StO2 derived variables with VO2, VCO2 and respiratory quotient (measured using indirect calorimetry).

  24 hours following surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing cardiac surgery with cardiopulmonary bypass in the university hospital of Lille.

You may qualify if:

• years old or more
• Cardiac surgery with cardiopulmonary bypass
• Tip of a central venous catheter positioned in superior vena cava or right atria
• Arterial catheter correctly positioned

You may not qualify if:

• KDIGO 3 AKI prior to surgery
• Hepatic insufficiency prior to surgery
• Extracorporeal life support prior to surgery '
• Live expectancy lower than 48 hours
• pregnancy

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Service d'Anesthésie-Réanimation CCV Hôpital Cardiologique Centre Hospitalier et Universitaire de Lille

Lille, NORD, 59000, France

Location

Related Publications (9)

• Shahbazi S, Khademi S, Shafa M, Joybar R, Hadibarhaghtalab M, Sahmeddini MA. Serum Lactate Is not Correlated with Mixed or Central Venous Oxygen Saturation for Detecting Tissue Hypo Perfusion During Coronary Artery Bypass Graft Surgery: A Prospective Observational Study. Int Cardiovasc Res J. 2013 Dec;7(4):130-4. Epub 2013 Dec 1.

  PMID: 24757637 RESULT

• Laine GA, Hu BY, Wang S, Thomas Solis R, Reul GJ Jr. Isolated high lactate or low central venous oxygen saturation after cardiac surgery and association with outcome. J Cardiothorac Vasc Anesth. 2013 Dec;27(6):1271-6. doi: 10.1053/j.jvca.2013.02.031. Epub 2013 Sep 5.

  PMID: 24011873 RESULT

• Balzer F, Sander M, Simon M, Spies C, Habicher M, Treskatsch S, Mezger V, Schirmer U, Heringlake M, Wernecke KD, Grubitzsch H, von Heymann C. High central venous saturation after cardiac surgery is associated with increased organ failure and long-term mortality: an observational cross-sectional study. Crit Care. 2015 Apr 16;19(1):168. doi: 10.1186/s13054-015-0889-6.

  PMID: 25888321 RESULT

• Futier E, Robin E, Jabaudon M, Guerin R, Petit A, Bazin JE, Constantin JM, Vallet B. Central venous O(2) saturation and venous-to-arterial CO(2) difference as complementary tools for goal-directed therapy during high-risk surgery. Crit Care. 2010;14(5):R193. doi: 10.1186/cc9310. Epub 2010 Oct 29.

  PMID: 21034476 RESULT

• Gasparovic H, Gabelica R, Ostojic Z, Kopjar T, Petricevic M, Ivancan V, Biocina B. Diagnostic accuracy of central venous saturation in estimating mixed venous saturation is proportional to cardiac performance among cardiac surgical patients. J Crit Care. 2014 Oct;29(5):828-34. doi: 10.1016/j.jcrc.2014.04.012. Epub 2014 Apr 26.

  PMID: 24857639 RESULT

• Robin E, Futier E, Pires O, Fleyfel M, Tavernier B, Lebuffe G, Vallet B. Central venous-to-arterial carbon dioxide difference as a prognostic tool in high-risk surgical patients. Crit Care. 2015 May 13;19(1):227. doi: 10.1186/s13054-015-0917-6.

  PMID: 25967737 RESULT

• Ospina-Tascon GA, Umana M, Bermudez W, Bautista-Rincon DF, Hernandez G, Bruhn A, Granados M, Salazar B, Arango-Davila C, De Backer D. Combination of arterial lactate levels and venous-arterial CO2 to arterial-venous O 2 content difference ratio as markers of resuscitation in patients with septic shock. Intensive Care Med. 2015 May;41(5):796-805. doi: 10.1007/s00134-015-3720-6. Epub 2015 Mar 20.

  PMID: 25792204 RESULT

• Mallat J, Lemyze M, Meddour M, Pepy F, Gasan G, Barrailler S, Durville E, Temime J, Vangrunderbeeck N, Tronchon L, Vallet B, Thevenin D. Ratios of central venous-to-arterial carbon dioxide content or tension to arteriovenous oxygen content are better markers of global anaerobic metabolism than lactate in septic shock patients. Ann Intensive Care. 2016 Dec;6(1):10. doi: 10.1186/s13613-016-0110-3. Epub 2016 Feb 3.

  PMID: 26842697 RESULT

• Moussa MD, Durand A, Leroy G, Vincent L, Lamer A, Gantois G, Joulin O, Ait-Ouarab S, Deblauwe D, Caroline B, Decoene C, Vincentelli A, Vallet B, Labreuche J, Kipnis E, Robin E. Central venous-to-arterial PCO2 difference, arteriovenous oxygen content and outcome after adult cardiac surgery with cardiopulmonary bypass: A prospective observational study. Eur J Anaesthesiol. 2019 Apr;36(4):279-289. doi: 10.1097/EJA.0000000000000949.

  PMID: 30664011 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples in All patients, Microcirculation reactivity using thenar StO2 and vascular occlusion test, VCO2 and VO2 measurement using indirect calorimetry (at the discretion of attending physician)

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mouhamed MOUSSA, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: April 11, 2017
• Study Start: June 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 18, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)