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Clinical Trials/NCT03914976
NCT03914976
Completed
Not Applicable

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

Hospices Civils de Lyon1 site in 1 country90 target enrollmentMay 9, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgery--Complications
Sponsor
Hospices Civils de Lyon
Enrollment
90
Locations
1
Primary Endpoint
post-operative complications
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 9, 2019
End Date
November 19, 2020
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

post-operative complications

Time Frame: 28 days after surgery

post-operative complications of grade III or greater according to Clavien-Dindo classification

mean intraoperative PCO2 values

Time Frame: during surgery

PCO2 values will be collected every 2 hours during surgery

mean postoperative PCO2 values

Time Frame: within 24 hours after surgery

Study Sites (1)

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