NCT04547491: HPI-GOS

Hypotension Prediction With HPI Algorithm During Major Gynecologic Oncologic Surgery

Completed NA Last updated 2 December 2021

What this trial tests

NA trial testing HPI - hypotension prediction index in Intraoperative Hypotension in 60 participants. Completed in 30 June 2021.

Timeline

15 October 2020

Primary endpoint
30 April 2021

30 June 2021

Quick facts

Lead sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	15 October 2020
Primary completion	30 April 2021
Estimated completion	30 June 2021
Sites	1 location across Italy

Drugs / interventions tested

• HPI - hypotension prediction index
• GDT

Conditions studied

• Intraoperative Hypotension — all drugs for Intraoperative Hypotension →
• Hemodynamic Instability — all drugs for Hemodynamic Instability →
• Gynecologic Cancer — all drugs for Gynecologic Cancer →

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Who can join

18 and older, female only, with Intraoperative Hypotension or Hemodynamic Instability. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Hypotension Prediction Index guided Goal Directed therapy and the amount of Hypotension during Major Gynaecologic Oncologic Surgery: a Randomized Controlled clinical Trial.
   Frassanito L, Giuri PP, Vassalli F, Piersanti A, et al · · 2023 · cited 43× · PMID 37119322 · DOI 10.1007/s10877-023-01017-1