Norepinephrine Weaning Guided by the Hypotension Prediction Index in Vasoplegic Shock After Cardiac Surgery
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2024-07-03
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What this Trial Is About
Researchers are studying patients who develop vasoplegic syndrome, a condition causing low blood pressure after cardiac surgery involving extracorporeal circulation. This condition is linked to increased risk after surgery, and current guidelines recommend norepinephrine as a first treatment to reduce complications. However, too much or prolonged use of norepinephrine can also cause harm. This trial evaluates whether using a new monitoring device, the Acumen IQ, which predicts low blood pressure episodes, can improve how norepinephrine is reduced in these patients.
The study compares two groups of patients after cardiac surgery: one group follows a standard norepinephrine weaning protocol based on maintaining mean arterial pressure (MAP) above 65 mmHg, while the other group uses the same protocol guided additionally by the Hypotension Prediction Index (HPI) from the Acumen IQ device. This device predicts arterial hypotension episodes by calculating HPI values and helps detect when patients are dependent on blood volume. The interventional treatment period lasts 72 hours, with follow-up visits at the end of the protocol, at hospital discharge, and 30 days after inclusion to collect clinical and biological data.
Participants are monitored closely with arterial catheters to measure blood pressure and receive norepinephrine as needed. Researchers will track the duration of norepinephrine administration, frequency and duration of hypotensive episodes, fluid volumes given, and occurrences of complications such as stroke or kidney injury. The study lasts 30 days total to assess the clinical impact of the protocol, including mortality. The aim is to see if HPI guidance can safely reduce norepinephrine use and improve patient outcomes after cardiac surgery.
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Brief Title
Norepinephrine Weaning Guided by the Hypotension Prediction Index in Vasoplegic Shock After Cardiac Surgery
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Age over 18 years
Hospitalized in the cardiothoracic-vascular and respiratory intensive care unit at Amiens-Picardy University Hospital
Scheduled for on-pump cardiac surgery such as coronary artery bypass grafting, valve replacement, ascending aorta replacement, or combined surgery
Receiving norepinephrine after surgery to treat vasoplegic syndrome
Cardiac surgery performed less than 48 hours before inclusion
Hemodynamically stable with mean arterial pressure above 65 mmHg for more than 4 hours while on norepinephrine
Monitoring of mean arterial pressure using a radial or femoral arterial catheter
Social security beneficiary
Signed informed consent before surgery
You will not qualify if you...
Permanent arrhythmia such as atrial fibrillation, flutter, or frequent atrial extrasystoles
Treatment with dobutamine, epinephrine, or vasopressin analogs
Mechanical circulatory assistance after cardiac surgery
Hemorrhagic shock
Under legal guardianship or curatorship
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 72 hours
Participants receive a norepinephrine weaning protocol after cardiac surgery to treat vasoplegic syndrome, guided either by standard MAP-based protocol or by the Hypotension Prediction Index using the Acumen IQ medical device.
Norepinephrine weaning guided by the Hypotension Prediction Index in vasoplegic shock after cardiac surgery: protocol for a single-centre, open-label randomised controlled trial - the NORAHPI study.
Christophe Beyls, Thomas Lefebvre, Nicolas Mollet...