Intra-operative Hypotension and Post-operative Lactate Level After Pancreatic-duodenectomy. (HYPOL)

January 8, 2026 updated by: Michele Tedeschi, Istituto Clinico Humanitas

Intra-operative Hypotension and Post-operative Lactate Level After Pancreatic-duodenectomy. A Prospective Multicenter Observational Study (HYPOL Study)

Intraoperative hypotension is a frequent occurrence during pancreaticoduodenectomy (PD) and has been associated with impaired tissue perfusion and organ dysfunction. However, its specific relationship with early postoperative hyperlactatemia and clinical outcomes in PD patients remains poorly characterized.

Identifying a correlation between time-weighted average hypotension (TWA65) and postoperative lactate levels could provide valuable insights for optimizing intraoperative hemodynamic management and improving postoperative outcomes in high-risk abdominal surgery.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

The primary objective of the study is to evaluate the association between intraoperative hypotension, defined as TWA65 > 0.2 mmHg, and postoperative lactate levels (>2 mmol/L at RR0 and RR1), as well as lactate clearance. Secondary objectives include assessing the relationship between hyperlactatemia (>4 mmol/L), impaired lactate clearance (Lacclear < 0), and the incidence of postoperative complications. The study also investigates how intraoperative factors such as fluid balance, body temperature, duration of surgery, cardiac index (CI), and cardiac power index (CPI) affect lactate levels and clearance. The primary endpoints are postoperative lactate levels and lactate clearance, while secondary endpoints include hyperlactatemia, lactate clearance deficit, and their association with clinical outcomes.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milan
      • Milan, Milan, Italy, 20089
        • IRCCS Humanitas Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing open pancreaticoduodenectomy (PD), aged 18-80

Description

Inclusion Criteria:

  • Patients aged between 18 and 80 years
  • Undergoing open pancreaticoduodenectomy (DCP)

Exclusion Criteria:

  • Age under 18 or over 85 years
  • Severe cardiac disease classified as NYHA class III-IV
  • Cirrhotic liver disease
  • Pregnancy
  • Puerperium or breastfeeding
  • ASA (American Society of Anesthesiologists) physical status score greater than 3

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
patients undergoing pancreatic duodenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hypotensive events
Time Frame: 1 hour post operative
The primary objective of the study is to evaluate the association between intraoperative hypotension, defined as TWA65 > 0.2 mmHg, and postoperative lactate levels (>2 mmol/L at RR0 and RR1), as well as lactate clearance.
1 hour post operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum lactate
Time Frame: 7 days
assessing the relationship between hyperlactatemia (>4 mmol/L), impaired lactate clearance (Lacclear < 0), and the incidence of postoperative complications.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 7, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

January 8, 2026

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYPOL (Registry Identifier: HYPOL)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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