Clinical trial NCT05922982: Norepinephrine Weaning Guided by the Hypotension Prediction Index in Vasoplegic Shock After Cardiac Surgery
Official title: Norepinephrine Weaning Guided by the Hypotension Prediction Index in Vasoplegic Shock After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vasoplegia
Shock
Norepinephrine
Surgery
Keywords: vasoplegia
shock
hypotension prediction index
Acumen
CABG
norepinephrine
surgery
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the duration of norepinephrine administration between both groups
timeFrame: 72 hours
Secondary outcomes:
measure: Number of norepinephrine protocol weaning failures
timeFrame: 2 years
measure: Prevalence of hypotensive episodes monitored by the Acumen IQ® device
timeFrame: 72 hours
measure: Frequency of hypotensive episodes monitored by the Acumen IQ® device
timeFrame: 72 hours
measure: Duration of hypotensive episodes monitored by the Acumen IQ® device
timeFrame: 72 hours
measure: NE total dose
timeFrame: 72 hours
measure: Cumulative diuresis
timeFrame: 72 hours
measure: Volume of administrated fluids
timeFrame: 72 hours
measure: Total dose of vasoactive drugs
timeFrame: 72 hours
measure: Number of stroke
timeFrame: 72 hours
measure: Number of myocardial infarction
timeFrame: 72 hours
measure: Number of resuscitated cardiac arrest
timeFrame: 72 hours
measure: Number of acute kidney injury
timeFrame: 72 hours
measure: Number of mesenteric ischaemia
timeFrame: 72 hours
measure: Number of in-hospital mortality.
timeFrame: 72 hours
measure: Number of 30 days hospital mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
Study officials:
References: