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

Surgery--Complications Clinical Trial

— CARBODAV  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03914976
• Other study ID #: 69HCL19_0041
• Secondary ID: 2019-A00323-54
• Status: Completed
• Start date: May 9, 2019
• Est. completion date: November 19, 2020

Study information

• Verified date: August 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 19, 2020
• Est. primary completion date: November 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications
• Surgery--Complications

Intervention

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 ?PCO2 and the occurrence of major post-operative complications at day 28 in high-risk surgery (major hepatectomy, esophagectomy or duodeno- cephalic pancreatectomy)

Locations

Country	Name	City	State
France	Hôpital de la Croix Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean intraoperative PCO2 values	PCO2 values will be collected every 2 hours during surgery	during surgery
Primary	mean postoperative PCO2 values		within 24 hours after surgery
Primary	post-operative complications	post-operative complications of grade III or greater according to Clavien-Dindo classification	28 days after surgery