NCT07346274

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
3mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Jan 2026Jul 2026

Study Start

First participant enrolled

January 7, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 8, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 8, 2026

Last Update Submit

January 8, 2026

Conditions

Serum Lactate Post-pancreatic Duodenectomy

Keywords

serum lactateblood pressurehypotension

Outcome Measures

Primary Outcomes (1)

  • hypotensive events

    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 Outcomes (1)

  • serum lactate

    7 days

Study Arms (1)

patients undergoing pancreatic duodenectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Humanitas Research Hospital

Milan, Milan, 20089, Italy

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
mtedeschi

Study Record Dates

First Submitted

January 8, 2026

First Posted

January 16, 2026

Study Start

January 7, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)