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

N/AEnrolling By InvitationNCT07346274

Istituto Clinico Humanitas60 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Serum Lactate Post-pancreatic Duodenectomy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

hypotensive events

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.

Time frame: 1 hour post operative

Secondary Outcomes

serum lactate

assessing the relationship between hyperlactatemia (\>4 mmol/L), impaired lactate clearance (Lacclear \< 0), and the incidence of postoperative complications.

Time frame: 7 days