Clinical trial
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
Name
HPI vs NIBP
Description
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.
Trial arms
Trial start
2023-09-01
Estimated PCD
2025-09-01
Trial end
2025-09-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
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
Arms:
Hypotension Prediction Index
Other names:
HemoSphere, Clearsight
Norepinephrine
Patients in the HPI group will receive a norepinephrine bolus when HPI is below 85
Arms:
Hypotension Prediction Index, Non Invasive Blood Pressure
Other names:
noradrenaline
Size
150
Primary endpoint
Fetal Base excess
at birth
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2023-08-03
1 organization
1 product
2 indications
Product
NorepinephrineIndication
Hypotension during surgeryIndication
Drug-Induced Hypotension