Surgery--ComplicationsCARBODAVNCT03914976
Association of the Arteriovenous Difference in Carbon Dioxide and Its Relation to the Difference in Arteriovenous Oxygen Content With the Occurrence of Postoperative Complication
An observational study of Surgery--Complications, run by Hospices Civils de Lyon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery--Complications
- What is being tested?
- patient having to undergo a high risk programmed digestive surgery
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 9 May 2019to 19 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Surgery--Complications
- Being tested
- patient having to undergo a high risk programmed digestive surgery
- Keywords
- high-risk digestive surgery, intensive care unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient having to undergo a high risk programmed digestive surgeryProcedure or 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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: patient having to undergo a high risk programmed digestive surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean intraoperative PCO2 values
PCO2 values will be collected every 2 hours during surgery
Measured: during surgery
mean postoperative PCO2 values
Measured: within 24 hours after surgery
post-operative complications
post-operative complications of grade III or greater according to Clavien-Dindo classification
Measured: 28 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start9 May 2019
- Primary completion19 Nov 2020
- Study completion19 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgery--ComplicationsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathieu GAZON, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914976
- Sponsor's protocol ID
- 69HCL19_0041
- Other IDs
- 2019-A00323-54
- Acronym
- CARBODAV
- Status last verified
- Aug 2022
- First submitted
- 9 Apr 2019
- Last updated
- 29 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guilherme E, Delignette MC, Pambet H, Lebreton T, Bonnet A, Pradat P, Boucheny C, Guichon C, Aubrun F, Gazon M. PCO2 gap, its ratio to arteriovenous oxygen content, ScvO2 and lactate in high-risk abdominal surgery patients: An observational study. Anaesth Crit Care Pain Med. 2022 Apr;41(2):101033. doi: 10.1016/j.accpm.2022.101033. Epub 2022 Feb 14.
PubMed 35176527
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03914976
- Acronym / sponsor ID
- CARBODAV / 69HCL19_0041
- Conditions
- Surgery--Complications
- Keywords
- high-risk digestive surgery, intensive care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 May 2019 (actual)
- Primary completion
- 19 Nov 2020 (actual)
- Study completion
- 19 Nov 2020 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient who will have a high risk digestive surgery | – | Procedure: patient having to undergo a high risk programmed digestive surgerypatient who will have a high risk digestive surgery: esophagectomy, major hepatectomy> 3 segments, duodeno cephalic pancreatectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- Major patient
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient having to undergo a high risk programmed digestive surgeryThe 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) | Procedure or surgery | patient who will have a high risk digestive surgery |
Primary outcome
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
post-operative complications
Time frame: 28 days after surgery
post-operative complications of grade III or greater according to Clavien-Dindo classification
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Derived from this study: PubMed 35176527Guilherme E, Delignette MC, Pambet H, Lebreton T, Bonnet A, Pradat P, Boucheny C, Guichon C, Aubrun F, Gazon M. PCO2 gap, its ratio to arteriovenous oxygen content, ScvO2 and lactate in high-risk abdominal surgery patients: An observational study. Anaesth Crit Care Pain Med. 2022 Apr;41(2):101033. doi: 10.1016/j.accpm.2022.101033. Epub 2022 Feb 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathieu GAZON principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery--Complications, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean intraoperative PCO2 values (time frame: during surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03914976, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2022.