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NCT Number: NCT07306845

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

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.

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Key information

Conditions

Postoperative Outcome Whipple Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

predictors of postoperative outcome in Whipple Procedures

Other

CO₂-Derived Parameters & Lactate as Predictors of Postoperative outcome in Whipple Procedures and the occurrence of complications

Primary outcomes

  1. 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)

    Measured via arterial and central venous blood gases sampling throughout the Whipple procedure

  2. 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

    Measured via arterial and central venous blood gases

  3. 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

    calculated by dividing the previous 2 measurements (Pv-aCO₂/Ca-vO₂ )

Secondary outcomes

  1. 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

    Measured via arterial blood gases sampling

  2. occurrence of Postoperative complications

    Time frame: within 3 days in ICU for complications, 30 days postoperatively for mortality

    • Anastomotic leak rate (pancreaticojejunostomy, hepaticojejunostomy), Delayed gastric emptying (DGE), Postoperative pancreatic fistula (POPF),

  3. ICU length of stay

    Time frame: postoperative 3 days

    total ICU stay ( days)

  4. Occurrence of post-operative complications

    Time frame: postoperatively within 1 month

    30-day mortality

  5. occurrence of Organ dysfunction (AKI)

    Time frame: postoperatively within 3 days in ICU

    Organ dysfunction (AKI), a patient is considered to have AKI postoperatively if any one of the following occurs:

    Increase in serum creatinine ≥ 0.3 mg/dL (≥ 26.5 µmol/L) within 48 hours, OR Increase in serum creatinine to ≥ 1.5 times baseline, OR Urine output < 0.5 mL/kg/hr for ≥ 6 hours.

  6. occurrence of postoperative complication as acute liver dysfunction

    Time frame: postoperatively within 3 days

    Postoperative liver dysfunction is defined as new impairment in liver function occurring after surgery, typically within the first 48-72 hours, manifested by one or more of the following: 1.Hyperbilirubinemia Total bilirubin > 2 mg/dL (34 µmol/L) OR a rise > 50% from baseline, 2.Elevated Liver Enzymes Increase in AST or ALT greater than 2-3 × upper limit of normal (ULN) Coagulopathy INR ≥ 1.5

Study contacts

Contact information is provided by the study sponsor or research team.

Alaa Anwar Abdelrahman, MD

CONTACT

[email protected]

00201281218573

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 29, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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