An observational study in Serum Lactate Post-pancreatic Duodenectomy, sponsored by Istituto Clinico Humanitas. Enrolling by invitation at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Istituto Clinico Humanitas · Observational
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.
885 studies on the registry are indexed under Hypotension; 195 are open to participants now.
This study's planned enrollment of 60 is below the median of 90 across 265 observational studies indexed under Hypotension.
Browse Hypotension studies →Istituto Clinico Humanitas is the lead sponsor of 279 studies on the registry; 70 are open to participants now.
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Patients undergoing open pancreaticoduodenectomy (PD), aged 18-80
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Plan to share: No
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