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Association of the Arteriovenous Difference in Carbon Dioxide and Its Relation to the Difference in Arteriovenous Oxygen Content With the Occurrence of Postoperative Complication (CARBODAV)

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ClinicalTrials.gov Identifier: NCT03914976
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
Intra-operative hemodynamic management in high-risk surgery is a priority for the anesthesiologist. The current strategy is based on the continuous measurement of cardiac output and its maximization by vascular filling has many limitations: invasiveness, measurement difficulties, impaired performance, imperative surgical restriction of filling, lack of evaluation of flow rate and metabolic needs. Biomarkers may be able to detect early an inadequacy between cardiac output and tissue oxygen requirements, venous saturation with oxygen (ScvO2) and arteriovenous difference in partial pressure of carbon dioxide (ΔPCO2) as well as the appearance of cellular hypoxia (lactate and arteriovenous difference in partial pressure of carbon dioxide/arteriovenous difference in oxygen) (ΔPCO2) / DAVO2). Moreover, the medical literature remains poor on the evaluation of these markers in per-operative context all the more for ΔPCO2 and ΔPCO2 / DAVO2. It seems interesting to evaluate the potential of these tools, in patients with major surgery and at high risk (major hepatectomy, oesophagectomy and duodeno-pancreatectomy), to predict the risk of postoperative complications, especially since surgery involves a restrictive vascular filling strategy that may be potentially deleterious to the patient.

Condition or disease Intervention/treatment
Surgery--Complications Procedure: patient having to undergo a high risk programmed digestive surgery

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Association of the Arteriovenous Difference in Carbon Dioxide and Its Relation to the Difference in Arteriovenous Oxygen Content With the Occurrence of Postoperative Complication
Actual Study Start Date : May 9, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
patient who will have a high risk digestive surgery
patient who will have a high risk digestive surgery: esophagectomy, major hepatectomy> 3 segments, duodeno cephalic pancreatectomy
Procedure: patient having to undergo a high risk programmed digestive surgery
The objective is to determine if there is an association between the mean intraoperative values and within 24 hours postoperative ΔPCO2 and the occurrence of major post-operative complications at day 28 in high-risk surgery (major hepatectomy, esophagectomy or duodeno- cephalic pancreatectomy)




Primary Outcome Measures :
  1. mean intraoperative PCO2 values [ Time Frame: during surgery ]
    PCO2 values will be collected every 2 hours during surgery

  2. mean postoperative PCO2 values [ Time Frame: within 24 hours after surgery ]
  3. post-operative complications [ Time Frame: 28 days after surgery ]
    post-operative complications of grade III or greater according to Clavien-Dindo classification


Biospecimen Retention:   Samples Without DNA

It was estimated that there is between 40 and 60 ml of blood taken during this kind of intervention and in 24-hour postoperative intervention .

The completion of the study should result in an increase in blood volume taken from 5 to 10 mL



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study concerns patients operated for a high-risk digestive surgery, hospitalized postoperatively in intensive care unit (agreed in anesthesia consultation). These patients will also need to have an arterial catheter and a central venous line in the superior vena cava
Criteria

Inclusion Criteria:

Major patient

Patient eligible for a high risk scheduled gastrointestinal surgery from:

  • Esophagectomy
  • Major hepatectomy (≥ 3 segments)
  • Cephalic duodeno-pancreatectomy Patient with an arterial catheter and a central venous line in superior vena cava.

Patient hospitalized post-operatively in intensive care unit as agreed in consultation with preoperative anesthesia.

Exclusion Criteria:

  • Pregnant or lactating patients
  • Patient with an unstable acute condition at the time of surgery (acute heart, respiratory or renal failure, severe sepsis or septic shock, hemorrhagic shock)
  • Patient opposing his participation in the study
  • Patient protected by law (guardianship)
  • Patient deprived of liberty
  • Patient with a contraindication to the establishment of a central venous route in superior vena cava territory or a radial or femoral arterial catheter

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914976


Contacts
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Contact: Mathieu GAZON 4 26 10 92 57 ext +33 mathieu.gazon@chu-lyon.fr
Contact: Enrique Guilherme 6 09 22 59 88 ext +33 enriqueguilherme@hotmail.fr

Locations
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France
Hôpital de la Croix Rousse Recruiting
Lyon, France, 69004
Contact: Mathieu GAZON    4 26 10 92 57 ext +33    mathieu.gazon@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Mathieu GAZON Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03914976    
Other Study ID Numbers: 69HCL19_0041
2019-A00323-54 ( Other Identifier: ANSM )
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
high-risk digestive surgery
intensive care unit
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes