MedTrace Logo

Hypotension Prediction Index vs Norepinephrine Infusion for Prevention of Spinal Hypotension for Cesarean Delivery

NCT05970770 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-08-03

No results posted yet for this study

Summary

The goal of this randomized controlled trial is to compare for non inferiority for fetal wellbeing Hypotension Prediction Index - Guided Therapy and Continuous Norepinephrine Infusion in in the Prevention of Spinal Anesthesia-Induced Hypotension for Cesarean Delivery.

The main question it aims to answer are:

• are fetal arterial base excess comparable with the two treatments?

Participants will undergo continuous noninvasive hemodynamic monitoring with advanced Hypotension Prediction Index Researchers will compare with patients receiving continuous norepinephrine infusion and standard blood pressure monitoring with arm cuff.

Conditions

  • Hypotension During Surgery
  • Hypotension Drug-Induced

Interventions

DEVICE

Hypotension Prediction Index

in addition to standard monitoring, will have hemodynamic monitoring using HemoSphere (Edwards Lifesciences, Irvine, CA; internal memory 60 gigabyte, 10 gigabyte used for operating system) with ClearSight non-invasive hemodynamic monitoring and with the Hypotension Prediction Index software enabled. They will not receive preventive vasopressors but only norepinephrine boluses if Hypotension Prediction Index \>85

DRUG

Norepinephrine

Patients in the HPI group will receive a norepinephrine bolus when HPI is below 85

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Gaetano A Draisci, Prof · IRCCS fondazione policlinico universitario A. Gemelli

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2025-09-01
Completion
2025-09-01
FDA Drug
Yes
FDA Device
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05970770 on ClinicalTrials.gov