Actively Recruiting
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
142
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Norepinephrine Weaning Guided by the Hypotension Prediction Index in Vasoplegic Shock After Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Hospitalized in the cardiothoracic-vascular and respiratory intensive care unit of Amiens-Picardy University Hospital
- Scheduled for on-pump cardiac surgery such as coronary artery bypass grafting, valve replacement, ascending aorta replacement, or combined surgery
- Started norepinephrine after surgery to treat vasoplegic syndrome
- Cardiac surgery performed less than 48 hours ago
- Hemodynamically stable with mean arterial pressure over 65 mmHg for more than 4 hours while on norepinephrine
- Mean arterial pressure monitored via radial or femoral arterial catheter
- Has social security coverage
- Provided signed consent to participate before surgery
You will not qualify if you...
- Permanent arrhythmia such as atrial fibrillation, flutter, or frequent atrial extrasystoles
- Receiving treatment with dobutamine, epinephrine, or vasopressin analogs
- Preoperative chronic end-stage renal failure requiring extra-renal purification after surgery
- Pregnant
- Dependent on an internal or external pacemaker
- Body temperature below 36 degrees Celsius (hypothermia)
- On mechanical circulatory assistance after cardiac surgery
- Experiencing hemorrhagic shock
- Under guardianship or curatorship
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHU Amiens Picardie
Amiens, France
Actively Recruiting
Research Team
C
Christophe Beyls, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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