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

Hypotension During Surgery Clinical Trial

Official title:

Hypotension Prediction Index Therapy is Non-inferior to Continuous Norepinephrine Infusion for Fetal Wellbeing in the Prevention of Spinal Anesthesia-Induced Hypotension for Cesarean Delivery: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05970770
• Other study ID #: HPI vs NIBP
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 1, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: June 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Chiara Sonnino, MD
• Phone: +390630153105
• Email: chiara.sonnino[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypotension
• Hypotension Drug-Induced
• Hypotension During Surgery

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fetal Base excess	withdrawn from umbilical fetal artery as index of perioperative metabolic acidosis	at birth
Secondary	Hypotensive episodes	(sistolic blood pressure <80% of baseline values for <1 minute)	from spinal anesthesia until delivery
Secondary	Total vasopressor dose	total dose of micrograms administered during operation	from spinal anesthesia until delivery
Secondary	Hypertensive episodes	systolic blood pressure >140 mmHg and/or diastolic blood pressure >100 mmHg	from spinal anesthesia until delivery
Secondary	Fetal arterial pH	value of fetal ph at the analisys from umbilical artery withdrown at birth	at birth
Secondary	Apgar score	Apgar is a quick test performed on a baby at 1 and 5 minutes after birth, examines the baby's breathing effort, heart rate, muscle tone, reflexes, skin color. Each category is scored with 0, 1, or 2, depending on the observed condition. The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth.	at 5 minutes from birth