Intra-operative Hypotension and Post-operative Lactate Level After Pancreatic-duodenectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Serum Lactate Post-pancreatic Duodenectomy. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Intra-operative Hypotension and Post-operative Lactate Level After Pancreatic-duodenectomy. A Prospective Multicenter Observational Study
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.
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.
Primary outcome measures
- hypotensive events [Time frame: 1 hour post operative]
Secondary outcome measures (1)
- serum lactate [Time frame: 7 days]
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 (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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Humanitas Research Hospital — Milan
Identifiers
NCT: NCT07346274 · HYPOL · HYPOL