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

Istituto Clinico Humanitas

Status: Invitation-only

Conditions: Serum Lactate Post-pancreatic Duodenectomy

Study type: Observational

Funder types: Other

Identifiers

NCT07346274

HYPOL (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

patients undergoing pancreatic duodenectomy