Clinical trial · Interventional
Hypotension Prediction With HPI Algorithm During Major Gynecologic Oncologic Surgery
Hemodynamic Monitoring and Prediction of Hypotension Through the HPI Algorithm During Major Gynecologic Oncologic Surgery: a Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Intraoperative hypotension (IOH) is a rather common event during general surgery, with variable incidence that ranges between 5 and 99% based on the definition used. It is associated to significant complications including acute renal failure, myocardial damage, stroke and overall increased mortality, reason why the prevention and the reduction of hypotensive events through an appropriate proactive approach can potentially improve the patient's outcome. The Hypotension Prediction Index (HPI) is an algorithm derived from the analysis of the arterial waveform and it is expressed as an absolute value from 0 to 100. It has been demonstrated that the HPI is able to predict the occurrence of hypotensive events of patients undergoing major surgery under general anesthesia, providing also a guide for the appropriate treatment based on further calculated secondary hemodynamic variables that estimate patient's preload, cardiac contractility and afterload. Aim of this prospective randomized study is to compare the incidence of IOH during major gynecologic oncologic surgery among two groups of patients receiving standard hemodynamic monitoring versus HPI monitoring. The primary hypothesis is that hemodynamic management HPI-guided reduces the incidence, entity and duration of intraoperative hypotensive events, defined as mean arterial pressure (MAP) lower than 65 mmHg lasting more than one minute.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Hemodynamic Instability | — | UNRESOLVED | — |
| Intraoperative Hypotension | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GDT | Device | — | UNRESOLVED |
| HPI - hypotension prediction index | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- GDT group
- description
- Cardiac optimization with goal-directed therapy, liberal use of vasopressor agents.
- interventionNames
- Device: GDT
- type
- EXPERIMENTAL
- label
- HPI group
- description
- Hemodynamic management HPI-based, protocol-based use of fluids, vasopressors and inotropes.
- interventionNames
- Device: HPI - hypotension prediction index
Primary outcomes (1)
- measure
- Cumulative Intraoperative Hypotension
- timeFrame
- At the end of surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Major Gynecologic Oncologic surgery procedures (expected duration \> 2 hours) Exclusion Criteria: * Severe valvulopathy * Cardiac failure * Severe aortic stenosis * Severe cardiac arrhythmias * Coagulopathy * Contraindication to arterial calculation * Patient's refusal
References
Publications (1)
- DERIVEDFrassanito L, Giuri PP, Vassalli F, Piersanti A, Garcia MIM, Sonnino C, Zanfini BA, Catarci S, Antonelli M, Draisci G. Hypotension Prediction Index guided Goal Directed therapy and the amount of Hypotension during Major Gynaecologic Oncologic Surgery: a Randomized Controlled clinical Trial. J Clin Monit Comput. 2023 Aug;37(4):1081-1093. doi: 10.1007/s10877-023-01017-1. Epub 2023 Apr 29. PMID 37119322