- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05970770
Hypotension Prediction Index vs Norepinephrine Infusion for Prevention of Spinal Hypotension for Cesarean Delivery
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
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Chiara Sonnino, MD
- Phone Number: +390630153105
- Email: chiara.sonnino@policlinicogemelli.it
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hypotension Prediction Index
Patients will be monitored with Hypotension Prediction Index which will guide vasopressor therapy with boluses of norepinephrine
|
Patients in the HPI group will receive a norepinephrine bolus when HPI is below 85
Other Names:
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
Other Names:
|
Active Comparator: 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
|
Patients in the HPI group will receive a norepinephrine bolus when HPI is below 85
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fetal Base excess
Time Frame: at birth
|
withdrawn from umbilical fetal artery as index of perioperative metabolic acidosis
|
at birth
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hypotensive episodes
Time Frame: from spinal anesthesia until delivery
|
(sistolic blood pressure <80% of baseline values for <1 minute)
|
from spinal anesthesia until delivery
|
Total vasopressor dose
Time Frame: from spinal anesthesia until delivery
|
total dose of micrograms administered during operation
|
from spinal anesthesia until delivery
|
Hypertensive episodes
Time Frame: from spinal anesthesia until delivery
|
systolic blood pressure >140 mmHg and/or diastolic blood pressure >100 mmHg
|
from spinal anesthesia until delivery
|
Fetal arterial pH
Time Frame: at birth
|
value of fetal ph at the analisys from umbilical artery withdrown at birth
|
at birth
|
Apgar score
Time Frame: at 5 minutes from birth
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gaetano A Draisci, Prof, IRCCS fondazione policlinico universitario A. Gemelli
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypotension
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Norepinephrine
Other Study ID Numbers
- HPI vs NIBP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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