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

NCT ID: NCT07346274

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-07
• Study Completion Date: 2026-07-30

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.

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.

Conditions

Serum Lactate Post-pancreatic Duodenectomy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patients undergoing pancreatic duodenectomy

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Michele Tedeschi

mtedeschi

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Humanitas Research Hospital

Milan, Milan, Italy

Countries

Italy

Other Identifiers

HYPOL

Identifier Type: REGISTRY

Identifier Source: secondary_id

HYPOL

Identifier Type: -

Identifier Source: org_study_id