NCT07346274

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

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2026-01-07
• Primary completion: 2026-06-30
• Completion: 2026-07-30
• First posted: 2026-01-16
• Last updated: 2026-01-16

Locations

1 site across 1 country: Italy