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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07346274

Acronym

HYPOL

Enrollment

Registered

2026-01-16

Start date

2026-01-07

Completion date

2026-07-30

Last updated

2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Serum Lactate Post-pancreatic Duodenectomy

Keywords

serum lactate, blood pressure, hypotension

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 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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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 (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

Design outcomes

Primary

Measure	Time frame	Description
hypotensive events	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

Measure	Time frame	Description
serum lactate	7 days	assessing the relationship between hyperlactatemia (\>4 mmol/L), impaired lactate clearance (Lacclear \< 0), and the incidence of postoperative complications.

Countries

Italy

Outcome results