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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Outcome; Whipple Procedures
• Intervention / Treatment: Other: predictors of postoperative outcome in Whipple Procedures

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

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alaa Anwar Abdelrahman, MD; Phone Number: 00201281218573; Email: A_Aly16@alexmed.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Predictors of Postoperative outcome in Whipple Procedures; Patients undergoing Whipple surgery monitored for CO₂-derived perfusion markers (Pv-aCO₂/Ca-vO₂ ratio) & Lactate as a traditional perfusion markers.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Venous-to-Arterial CO₂ Gap (Pv-aCO₂ = PvCO₂ - PaCO₂)	Measured via arterial and central venous blood gases sampling throughout the Whipple procedure	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)	Measured via arterial and central venous blood gases	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 )	calculated by dividing the previous 2 measurements (Pv-aCO₂/Ca-vO₂ )	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

Outcome Measure	Measure Description	Time Frame
Traditional Perfusion Markers :Lactate	Measured via arterial blood gases sampling	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	• Anastomotic leak rate (pancreaticojejunostomy, hepaticojejunostomy), Delayed gastric emptying (DGE), Postoperative pancreatic fistula (POPF),	within 3 days in ICU for complications, 30 days postoperatively for mortality
ICU length of stay	total ICU stay ( days)	postoperative 3 days
Occurrence of post-operative complications	30-day mortality	postoperatively within 1 month
occurrence of Organ dysfunction (AKI)	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.	postoperatively within 3 days in ICU
occurrence of postoperative complication as acute liver dysfunction	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	postoperatively within 3 days

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Alaa Anwar Abdelrahman, Dr, University of Alexandria

Study record dates

Study Major Dates

• Study Start (Estimated): December 25, 2025
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): June 25, 2026

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: December 13, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Blood Lactate; CO2 Pressure Difference; O2 Difference
• Other Study ID Numbers: IRPNO00012098

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No