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

NCT ID: NCT07306845

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-25

Study Completion Date

2026-06-25

Brief Summary

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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

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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

Conditions

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Whipple Procedures Postoperative Outcome

Keywords

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CO2 Pressure Difference O2 Difference Blood Lactate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

predictors of postoperative outcome in Whipple Procedures

Intervention Type OTHER

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

Interventions

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predictors of postoperative outcome in Whipple Procedures

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

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Alaa Anwar Aly Ahmed

LECTURER OF ANESTHESIA AND SURGICAL INTENSIVE CARE

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alaa Anwar Abdelrahman, Dr

Role: PRINCIPAL_INVESTIGATOR

University of Alexandria

Central Contacts

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Alaa Anwar Abdelrahman, MD

Role: CONTACT

Phone: 00201281218573

Email: [email protected]

Other Identifiers

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IRPNO00012098

Identifier Type: -

Identifier Source: org_study_id