Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07346274

Intra-operative Hypotension and Post-operative Lactate Level After Pancreatic-duodenectomy

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 inpancreaticoduodenectomy (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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Serum Lactate Post-pancreatic Duodenectomy Cardiovascular Diseases Hypotension Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Humanitas Research Hospital

Milan, 20089, Italy

About this study

The primary objective of the study is to evaluate the association between intraoperative hypotension, defined as time-weighted average hypotension TWA65 > 0.2 mmHg, and postoperative lactate levels (>2 mmol/L at at time of arrival (RR0) and after 1 hour (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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 (New York Heart Association) class III-IV
  • Cirrhotic liver disease
  • Pregnancy
  • Puerperium or breastfeeding
  • ASA (American Society of Anesthesiologists) physical status score greater than 3

Treatment and study plan

Primary outcomes

  1. hypotensive events

    Time frame: 1 hour post operative

    The primary objective of the study is to evaluate the association between intraoperative hypotension, defined as Time-Weighted Average of intraoperative hypotension (TWA65) > 0.2 mmHg, and postoperative lactate levels (>2 mmol/L at RR0 and RR1 (at time of arrival (RR0) and after 1 hour (RR1), as well as lactate clearance.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

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

Acronym: HYPOL

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.