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

NCT07306845 | Not Yet Recruiting

• 1 other identifier: IRPNO00012098
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postoperative Outcome; Whipple Procedures

Keywords

CO2 Pressure Difference; O2 Difference; Blood Lactate

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Traditional Perfusion Markers :Lactate

  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

  within 3 days in ICU for complications, 30 days postoperatively for mortality

• ICU length of stay

  postoperative 3 days

• Occurrence of post-operative complications

  postoperatively within 1 month

• occurrence of Organ dysfunction (AKI)

  postoperatively within 3 days in ICU

Study Arms (1)

Predictors of Postoperative outcome in Whipple Procedures

OTHER

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

Interventions

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

Predictors of Postoperative outcome in Whipple Procedures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Study Officials

• Alaa Anwar Abdelrahman, Dr

  University of Alexandria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaa Anwar Abdelrahman, MD

CONTACT

00201281218573; A_Aly16@alexmed.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: LECTURER OF ANESTHESIA AND SURGICAL INTENSIVE CARE

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 29, 2025
• Study Start: December 25, 2025
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): June 25, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share