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

NCT ID: NCT05970770

Last Updated: 2023-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-09-01

Brief 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.

Detailed Description

In the Hypotension Prediction Index group, patients will be monitored continuously with a noninvasive hemodynamic device. The Hypotension Prediction Index is a number based on al algorithm that predicts impeding hypotension if it is greater than 85. In the treatment group, patients will be treated with norepinephrine boluses if the Hypotension Prediction Index is >85. In the control group patients will be treated with preventive continuous infusion of norepinephrine and blood pressure will be measured noninvasively every minute. Data about blood pressure and the vasopressive treatment will start concomitantly to the administration of spinal anesthesia and will stop after delivery. blood gas samples will be then collected from the placental umbilical artery to compare fetal arterial base excess as primary outcome for non-inferiority.

Conditions

Hypotension During Surgery; Hypotension Drug-Induced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hypotension Prediction Index

Patients will be monitored with Hypotension Prediction Index which will guide vasopressor therapy with boluses of norepinephrine

Group Type: EXPERIMENTAL

Hypotension Prediction Index

Intervention Type: DEVICE

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

Norepinephrine

Intervention Type: DRUG

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

Non Invasive Blood Pressure

Spinal-induced hypotension will be prevented by continuous preventive norepinephrine infusion and blood pressure will be monitored by non invasive arm cuff every minute

Group Type: ACTIVE_COMPARATOR

Norepinephrine

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DEVICE

Norepinephrine

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

Intervention Type: DRUG

Other Intervention Names

HemoSphere; Clearsight; noradrenaline

Eligibility Criteria

Inclusion Criteria

• Pregnant women between the 36th and the 40th week of gestation undergoing spinal anesthesia for elective caesarian delivery.

Exclusion Criteria

• preeclampsia;
• eclampsia;
• atrial fibrillation and sinus tachycardia;
• cardiovascular diseases;
• neuromuscular disease;
• emergent or urgent cesarean delivery;
• coagulopathies;
• contraindications to spinal anesthesia.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gaetano A Draisci, Prof

Role: PRINCIPAL_INVESTIGATOR

IRCCS fondazione policlinico universitario A. Gemelli

Central Contacts

Chiara Sonnino, MD

Role: CONTACT

chiara.sonnino@policlinicogemelli.it

+390630153105

Other Identifiers

HPI vs NIBP

Identifier Type: -

Identifier Source: org_study_id