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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hypotension During Surgery, Hypotension Drug-Induced

Intervention / Treatment
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* Device: Hypotension Prediction Index
* Drug: Norepinephrine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypotension Prediction Index<br>Patients will be monitored with Hypotension Prediction Index which will guide vasopressor therapy with boluses of norepinephrine | Device: Hypotension Prediction Index<br>* 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<br>* Other names: Clearsight;Drug: Norepinephrine<br>* Patients in the HPI group will receive a norepinephrine bolus when HPI is below 85<br>* Other names: noradrenaline;|
| Active Comparator: Non Invasive Blood Pressure<br>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<br>* Patients in the HPI group will receive a norepinephrine bolus when HPI is below 85<br>* Other names: noradrenaline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal Base excess | withdrawn from umbilical fetal artery as index of perioperative metabolic acidosis | at birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypotensive episodes | (sistolic blood pressure <80% of baseline values for <1 minute) | from spinal anesthesia until delivery | 
| Total vasopressor dose | total dose of micrograms administered during operation | from spinal anesthesia until delivery | 
| Hypertensive episodes | systolic blood pressure >140 mmHg and/or diastolic blood pressure >100 mmHg | from spinal anesthesia until delivery | 
| Fetal arterial pH | value of fetal ph at the analisys from umbilical artery withdrown at birth | at birth | 
| 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 |