Hypotension During SurgeryPhase 4NCT05970770
Hypotension Prediction Index vs Norepinephrine Infusion for Prevention of Spinal Hypotension for Cesarean Delivery
A Phase 4 study testing Hypotension Prediction Index and Norepinephrine in people with Hypotension During Surgery and Hypotension Drug-Induced, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Hypotension During Surgery, Hypotension Drug-Induced
- What is being tested?
- Hypotension Prediction Index and Norepinephrine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Sep 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women between the 36th and the 40th week of gestation undergoing spinal anesthesia for elective caesarian delivery.
Who cannot join
- preeclampsia;
- eclampsia;
- atrial fibrillation and sinus tachycardia;
- cardiovascular diseases;
- neuromuscular disease;
- emergent or urgent cesarean delivery;
- coagulopathies;
- contraindications to spinal anesthesia.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the detailed 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.
- Being tested
- Hypotension Prediction Index, Norepinephrine
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypotension Prediction IndexDevice
Also called HemoSphere, Clearsight
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
NorepinephrineDrug
Also called noradrenaline
Patients in the HPI group will receive a norepinephrine bolus when HPI is below 85
| Study group | Role | What they receive |
|---|---|---|
| Hypotension Prediction Index | Experimental | Patients will be monitored with Hypotension Prediction Index which will guide vasopressor therapy with boluses of norepinephrine Receives: 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 Receives: Drug: Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal Base excess
withdrawn from umbilical fetal artery as index of perioperative metabolic acidosis
Measured: at birth
Secondary outcomes (5)
Hypotensive episodes
(sistolic blood pressure <80% of baseline values for <1 minute)
Measured: from spinal anesthesia until delivery
Total vasopressor dose
total dose of micrograms administered during operation
Measured: from spinal anesthesia until delivery
Hypertensive episodes
systolic blood pressure >140 mmHg and/or diastolic blood pressure >100 mmHg
Measured: from spinal anesthesia until delivery
Fetal arterial pH
value of fetal ph at the analisys from umbilical artery withdrown at birth
Measured: 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.
Measured: at 5 minutes from birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension During SurgeryStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaetano A Draisci, Prof, Principal investigator, IRCCS fondazione policlinico universitario A. Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970770
- Sponsor's protocol ID
- HPI vs NIBP
- Status last verified
- Jun 2023
- First submitted
- 24 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05970770
- Acronym / sponsor ID
- HPI vs NIBP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypotension Prediction Index | Experimental | Device: Hypotension Prediction Index, Drug: NorepinephrinePatients will be monitored with Hypotension Prediction Index which will guide vasopressor therapy with boluses of norepinephrine |
| Non Invasive Blood Pressure | Active comparator | Drug: NorepinephrineSpinal-induced hypotension will be prevented by continuous preventive norepinephrine infusion and blood pressure will be monitored by non invasive arm cuff every minute |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women between the 36th and the 40th week of gestation undergoing spinal anesthesia for elective caesarian delivery.
Key exclusion criteria (8 listed)
- preeclampsia;
- eclampsia;
- atrial fibrillation and sinus tachycardia;
- cardiovascular diseases;
- neuromuscular disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypotension Prediction IndexAlso: HemoSphere, Clearsightin 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 | Device | Hypotension Prediction Index |
| NorepinephrineAlso: noradrenalinePatients in the HPI group will receive a norepinephrine bolus when HPI is below 85 | Drug | Hypotension Prediction Index, Non Invasive Blood Pressure |
Primary outcome
Fetal Base excess
Time frame: at birth
withdrawn from umbilical fetal artery as index of perioperative metabolic acidosis
5 secondary outcomes
Hypotensive episodes
Time frame: from spinal anesthesia until delivery
Total vasopressor dose
Time frame: from spinal anesthesia until delivery
Hypertensive episodes
Time frame: from spinal anesthesia until delivery
Fetal arterial pH
Time frame: at birth
Apgar score
Time frame: at 5 minutes from birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaetano A Draisci, Prof principal investigator
IRCCS fondazione policlinico universitario A. Gemelli
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hypotension Prediction Index and Norepinephrine in people with Hypotension During Surgery and Hypotension Drug-Induced, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chiara Sonnino, MD (+390630153105, chiara.sonnino@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal Base excess (time frame: at birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.