Hypotension Prediction With HPI Algorithm During Major Gynecologic Oncologic Surgery

NCT04547491 | Completed

• 1 other identifier: ID 3672
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Intraoperative Hypotension; Hemodynamic Instability; Gynecologic Cancer

Keywords

hypotension prediction; hemodynamic monitoring

Outcome Measures

Primary Outcomes (1)

• Cumulative Intraoperative Hypotension

  Comparison, in the two groups, of the amount of intraoperative hypotension (MAP \< 65 mmHg), measured with TWA-MAP method.

  At the end of surgery

Secondary Outcomes (3)

• Hypotension after anesthesia induction

  20 minutes after anesthesia induction

• Severe hypotension

  At the end of surgery

• Adverse events

  At 7 days after surgery.

Study Arms (2)

GDT group

OTHER

Cardiac optimization with goal-directed therapy, liberal use of vasopressor agents.

Device: GDT

HPI group

EXPERIMENTAL

Hemodynamic management HPI-based, protocol-based use of fluids, vasopressors and inotropes.

Device: HPI - hypotension prediction index

Interventions

HPI - hypotension prediction index DEVICE

treatment of hypotension before the appearance following HPI algorithm

HPI group

GDT DEVICE

cardiac optimization and treatment of hypotension following standard clinical practice

GDT group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Gynecological surgery
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major Gynecologic Oncologic surgery procedures (expected duration \> 2 hours)

You may not qualify if:

• Severe valvulopathy
• Cardiac failure
• Severe aortic stenosis
• Severe cardiac arrhythmias
• Coagulopathy
• Contraindication to arterial calculation
• Patient's refusal

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

IRCCS Policlinico Agostino Gemelli

Rome, 00168, Italy

Location

Related Publications (1)

• Frassanito 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 DERIVED

Study Officials

• Gaetano Draisci, MD

  IRCCS Fondazione Policlinico A. Gemelli

  STUDY DIRECTOR

• Luciano Frassanito, MD

  IRCCS Fondazione Policlinico A. Gemelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: September 14, 2020
• Study Start: October 15, 2020
• Primary Completion: April 30, 2021
• Study Completion: June 30, 2021
• Last Updated: December 2, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)