Postoperative OutcomeNCT07306845
Veno-arterial CO2 Pressure Difference to Arterio-venous O2 Difference Ratio & Blood Lactate Levels Are Predictors of Postoperative Outcome in Whipple Procedures
A study testing predictors of postoperative outcome in Whipple Procedures in people with Postoperative Outcome and Whipple Procedures, run by Alexandria University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Outcome, Whipple Procedures
- What is being tested?
- predictors of postoperative outcome in Whipple Procedures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 25 Dec 2025to 25 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (>18 years) undergoing open Whipple procedure under general anesthesia
- Invasive monitoring (arterial line and central venous catheter)
- Informed written consent
Who cannot join
- Emergency surgery.
- Preoperative septic shock or hemodynamic instability.
- severe pre-existing **cardiopulmonary disease (e.g., severe COPD, heart failure).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
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.
Read the 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
- Conditions
- Postoperative Outcome, Whipple Procedures
- Being tested
- predictors of postoperative outcome in Whipple Procedures
- Keywords
- CO2 Pressure Difference, O2 Difference, Blood Lactate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
predictors of postoperative outcome in Whipple ProceduresOther
CO₂-Derived Parameters \& Lactate as Predictors of Postoperative outcome in Whipple Procedures and the occurrence of complications
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: predictors of postoperative outcome in Whipple Procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous-to-Arterial CO₂ Gap (Pv-aCO₂ = PvCO₂ - PaCO₂)
Measured via arterial and central venous blood gases sampling throughout the Whipple procedure
Measured: 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
Measured: 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 )
Measured: 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
Measured via arterial blood gases sampling
Measured: 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),
Measured: within 3 days in ICU for complications, 30 days postoperatively for mortality
ICU length of stay
total ICU stay ( days)
Measured: postoperative 3 days
Occurrence of post-operative complications
30-day mortality
Measured: 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.
Measured: 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
Measured: postoperatively within 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start25 Dec 2025 (estimated)
- Primary completion25 Jun 2026 (estimated)
- Study completion25 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative OutcomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Anwar Aly Ahmed, Alexandria University
- Investigators
- Alaa Anwar Abdelrahman, Dr, Principal investigator, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306845
- Sponsor's protocol ID
- IRPNO00012098
- Status last verified
- Dec 2025
- First submitted
- 16 Nov 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Veno-arterial CO2 Pressure Difference to Arterio-venous O2 Difference Ratio & Blood Lactate Levels Are Predictors of Postoperative Outcome in Whipple Procedures
- ClinicalTrials.gov ID
- NCT07306845
- Acronym / sponsor ID
- IRPNO00012098
- Conditions
- Postoperative Outcome, Whipple Procedures
- Keywords
- CO2 Pressure Difference, O2 Difference, Blood Lactate
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 25 Dec 2025 (estimated)
- Primary completion
- 25 Jun 2026 (estimated)
- Study completion
- 25 Jun 2026 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Predictors of Postoperative outcome in Whipple Procedures | Other | Other: predictors of postoperative outcome in Whipple ProceduresPatients undergoing Whipple surgery monitored for CO₂-derived perfusion markers (Pv-aCO₂/Ca-vO₂ ratio) \& Lactate as a traditional perfusion markers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (>18 years) undergoing open Whipple procedure under general anesthesia
- Invasive monitoring (arterial line and central venous catheter)
- Informed written consent
Key exclusion criteria (3 listed)
- Emergency surgery.
- Preoperative septic shock or hemodynamic instability.
- severe pre-existing **cardiopulmonary disease (e.g., severe COPD, heart failure).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| predictors of postoperative outcome in Whipple ProceduresCO₂-Derived Parameters \& Lactate as Predictors of Postoperative outcome in Whipple Procedures and the occurrence of complications | Other | Predictors of Postoperative outcome in Whipple Procedures |
Primary outcome
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
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
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 )
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alaa Anwar Abdelrahman, Dr principal investigator
University of Alexandria
Questions about this trial
What is this clinical trial studying?
A study testing predictors of postoperative outcome in Whipple Procedures in people with Postoperative Outcome and Whipple Procedures, run by Alexandria University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alaa Anwar Abdelrahman, MD (00201281218573, A_Aly16@alexmed.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.