- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05922982
Norepinephrine Weaning Guided by the Hypotension Prediction Index in Vasoplegic Shock After Cardiac Surgery (NORAHPI)
In postoperative cardiac surgery under extracorporeal circulation, the patient may develop a vasoplegic syndrome, characterized by arterial hypotension (mean arterial pressure (MAP) < 65 mmHg); a decrease in vascular resistance and a cardiac output that may be normal or increased, and increased postoperative mortality/ International recommendations recommend the prescription of noradrenaline as a first-line treatment to reduce morbidity and mortality. However, excess norepinephrine or duration of exposure is also deleterious. The Acumen IQ device (Edwards Lifesciences) allows the calculation of a predictive index of arterial hypotension episodes (predictive hypotension index, HPI). HPI could improve norepinephrine weaning by preventing episodes of arterial hypotension or detecting preload dependence, thus avoiding the transient increase in norepinephrine during hypotension.
This is a single-center, prospective, open-label, randomized, controlled, 2-group, parallel, intention-to-treat study. The aim was to evaluate the superiority of a new decision algorithm, based on the HPI delivered by the Acumen IQ device, to reduce the duration of norepinephrine administration in post-cardiac surgery vasoplegic shock.
The duration of the interventional protocol is 72 hours. To evaluate the clinical impact of the protocol, the time of the study will be 30 days. Several follow-up visits will be performed (end-of-protocol day, discharge day, and at D30 of inclusion) to collect clinical, biological, and HPI monitoring data.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christophe Beyls, MD
- Phone Number: 0322087866
- Email: Beyls.Christophe@chu-amiens.fr
Study Locations
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-
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Amiens, France
- CHU Amiens Picardie
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Sub-Investigator:
- Osama ABOU ARAB, MD
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Contact:
- Christophe Beyls, MD
- Phone Number: 0322087866
- Email: Beyls.Christophe@chu-amiens.fr
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Sub-Investigator:
- Yazine Mahjoub, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age > 18 years
- The patient was hospitalized in the cardiothoracic-vascular and respiratory intensive care unit of Amiens-Picardy University Hospital.
- Patient scheduled for on-pomp cardiac surgery [coronary artery bypass grafting, valve replacement, ascending aorta replacement, or combined surgery (valve and bypass grafting)].
- Introduction of norepinephrine post-surgery for the treatment of vasoplegic syndrome.
- On-pomp cardiac surgery in less than 48 hours.
- Hemodynamically stable patient with MAP > 65 mmHg for more than 4 hours on noradrenaline
- Monitoring of MAP with a radial or femoral arterial catheter
- Social security beneficiary
- Signature of the consent to participate in the study by the patient, preoperatively
Exclusion Criteria:
- Permanent arrhythmia (atrial fibrillation, flutter, or frequent atrial extrasystoles).
- Treatment with dobutamine, epinephrine, or vasopressin analog
- Patients with preoperative chronic end-stage renal failure require postoperative extra-renal purification.
- Pregnant woman
- The patient is dependent on an internal or external pacemaker.
- Hypothermia < 36°.
- Patient under mechanical circulatory assistance after cardiac surgery.
- Hemorrhagic shock
- Patient under guardianship or curators
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard care arm
MAP-based (MAP > 65 mmHg) norepinephrine weaning protocol
|
MAP-based (MAP > 65 mmHg) norepinephrine weaning protocol
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Experimental: Experimental arm (HPI-guided)
MAP-based (MAP > 65 mmHg) norepinephrine weaning protocol and guided by the HPI (HPI<80) delivered by the Acumen IQ medical device.
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MAP-based (MAP > 65 mmHg) norepinephrine weaning protocol and guided by the HPI (HPI<80) delivered by the Acumen IQ medical device.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
variation of the duration of norepinephrine administration between both groups
Time Frame: 72 hours
|
72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of norepinephrine protocol weaning failures
Time Frame: 2 years
|
Number of norepinephrine protocol weaning failures, defined as persistent norepinephrine delivery 72 hours after the start of inclusion
|
2 years
|
Collaborators and Investigators
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
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Postoperative Complications
- Shock
- Hypotension
- Vasoplegia
- 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
- PI2023_843_0046
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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