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Not yet recruiting NCT07306845

Veno-arterial CO2 Pressure Difference to Arterio-venous O2 Difference Ratio & Blood Lactate Levels Are Predictors of Postoperative Outcome in Whipple Procedures

No phase Interventional Postoperative Outcome Whipple Procedures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: predictors of postoperative outcome in Whipple Procedures.
Who it may be relevant to
Registry conditions: Postoperative Outcome, Whipple Procedures. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Whipple surgery is a complex abdominal procedure associated with a high risk of hemodynamic instability and splanchnic hypoperfusion leading to anastomotic leaks, delayed gastric emptying, and organ dysfunction Traditional markers (e.g., MAP, mixed venous oxygen saturation \[SvO₂\], lactate) are indirect, invasive and often delayed. CO₂-derived variables (e.g., venous-to-arterial CO₂ gap \[ΔCO₂\], tissue CO₂ \[PtCO₂\], end-tidal CO₂ \[EtCO₂\] changes) provide earlier and more sensitive signs of microcirculatory dysfunction.

Detailed description

Whipple surgery is a complex abdominal procedure associated with a high risk of hemodynamic instability and splanchnic hypoperfusion leading to anastomotic leaks, delayed gastric emptying, and organ dysfunction Traditional markers (e.g., MAP, mixed venous oxygen saturation \[SvO₂\], lactate) are indirect, invasive and often delayed.

CO₂-derived variables (e.g., venous-to-arterial CO₂ gap \[ΔCO₂\], tissue CO₂ \[PtCO₂\], end-tidal CO₂ \[EtCO₂\] changes) provide earlier and more sensitive signs of microcirculatory dysfunction.

The present study investigate the hypothesis that simultaneous measurement of Venous-to-Arterial CO₂ Gap Indexed to Oxygen Content Difference (Pv-aCO₂/Ca-vO₂ Ratio \& blood lactate may provide one or more early markers for post-operative adverse outcome in Whipple procedure

Interventions

  • Other predictors of postoperative outcome in Whipple Procedures
    CO₂-Derived Parameters \& Lactate as Predictors of Postoperative outcome in Whipple Procedures and the occurrence of complications

Primary outcome measures

  • Venous-to-Arterial CO₂ Gap (Pv-aCO₂ = PvCO₂ - PaCO₂) [Time frame: T0 baseline (After induction of anesthesia) T1 intraoperative (After major vessel dissection) T2 intraoperative (Immediately post-pancreatic resection) T3 intraoperative (After GIT anastomosis) T4 End of surgery T5 postoperative (2 hours)]
  • Arterial-Venous oxygen content difference (Ca-vO₂ = CaO₂ - CvO₂) [Time frame: T0 baseline (After induction of anesthesia) T1 intraoperative (After major vessel dissection) T2 intraoperative (Immediately post-pancreatic resection) T3 intraoperative (After GIT anastomosis) T4 End of surgery T5 postoperative (2 hours) in ICU]
  • Veno-arterial CO2 Pressure Difference to Arterio-venous O2 Difference Ratio (Pv-aCO₂/Ca-vO₂ ratio ) [Time frame: T0 baseline (After induction of anesthesia) T1 intraoperative (After major vessel dissection) T2 intraoperative (Immediately post-pancreatic resection) T3 intraoperative (After GIT anastomosis) T4 End of surgery T5 postoperative (2 hours) in ICU]
Secondary outcome measures (6)
  • Traditional Perfusion Markers :Lactate [Time frame: T0 baseline (After induction of anesthesia) T1 intraoperative (After major vessel dissection) T2 intraoperative (Immediately post-pancreatic resection) T3 intraoperative (After GIT anastomosis) T4 End of surgery T5 postoperative (2 hours) in ICU]
  • occurrence of Postoperative complications [Time frame: within 3 days in ICU for complications, 30 days postoperatively for mortality]
  • ICU length of stay [Time frame: postoperative 3 days]
  • Occurrence of post-operative complications [Time frame: postoperatively within 1 month]
  • occurrence of Organ dysfunction (AKI) [Time frame: postoperatively within 3 days in ICU]
  • occurrence of postoperative complication as acute liver dysfunction [Time frame: postoperatively within 3 days]

Eligibility criteria

Inclusion criteria

  • Adults (>18 years) undergoing open Whipple procedure under general anesthesia
  • Invasive monitoring (arterial line and central venous catheter)
  • Informed written consent

Exclusion criteria

  • Emergency surgery.
  • Preoperative septic shock or hemodynamic instability.
  • severe pre-existing \*\*cardiopulmonary disease (e.g., severe COPD, heart failure).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07306845 · IRPNO00012098

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗