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

NCT05970770 | Unknown Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: HPI vs NIBP
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypotension During Surgery; Hypotension Drug-Induced

Outcome Measures

Primary Outcomes (1)

• Fetal Base excess

  withdrawn from umbilical fetal artery as index of perioperative metabolic acidosis

  at birth

Secondary Outcomes (5)

• Hypotensive episodes

  from spinal anesthesia until delivery

• Total vasopressor dose

  from spinal anesthesia until delivery

• Hypertensive episodes

  from spinal anesthesia until delivery

• Fetal arterial pH

  at birth

• Apgar score

  at 5 minutes from birth

Study Arms (2)

Hypotension Prediction Index

EXPERIMENTAL

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

Device: Hypotension Prediction Index; Drug: Norepinephrine

Non Invasive Blood Pressure

ACTIVE COMPARATOR

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

Drug: Norepinephrine

Interventions

Hypotension Prediction Index 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

Also known as: HemoSphere, Clearsight

Hypotension Prediction Index

Norepinephrine DRUG

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

Also known as: noradrenaline

Hypotension Prediction Index; Non Invasive Blood Pressure

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: pregnant women at term
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Hypotension

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Gaetano A Draisci, Prof

  IRCCS fondazione policlinico universitario A. Gemelli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiara Sonnino, MD

CONTACT

+390630153105; chiara.sonnino@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 1, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 3, 2023

Record last verified: 2023-06