An interventional study of norepinephrine weaning protocol and norepinephrine weaning protocol and guided by the HPI in Vasoplegia, Shock and Norepinephrine, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Other
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.
Exclusion Criteria:
MAP-based (MAP \> 65 mmHg) norepinephrine weaning protocol
Drug: norepinephrine weaning protocol
MAP-based (MAP \> 65 mmHg) norepinephrine weaning protocol and guided by the HPI (HPI\<80) delivered by the Acumen IQ medical device.
Drug: norepinephrine weaning protocol and guided by the HPI
MAP-based (MAP \> 65 mmHg) norepinephrine weaning protocol
MAP-based (MAP \> 65 mmHg) norepinephrine weaning protocol and guided by the HPI (HPI\<80) delivered by the Acumen IQ medical device.
Comparison of the duration of norepinephrine administration between both groups
The duration will be defined as the difference in time between the beginning of the study (day 0) and the end of the study protocol (day 3).
Time frame: 72 hours
Number of norepinephrine protocol weaning failures
Number of norepinephrine protocol weaning failures, defined as persistent norepinephrine delivery 72 hours after the start of inclusion
Time frame: 2 years
Prevalence of hypotensive episodes monitored by the Acumen IQ® device
Hypotension is defined by the presence of a mean arterial pressure \< 65 mmHg for a minimum duration of 30 seconds. Blood pressure must be invasive and monitored on the HemoSphere® monitor.
Time frame: 72 hours
Frequency of hypotensive episodes monitored by the Acumen IQ® device
Hypotension is defined by the presence of a mean arterial pressure \< 65 mmHg for a minimum duration of 30 seconds. Blood pressure must be invasive and monitored on the HemoSphere® monitor.
Time frame: 72 hours
Duration of hypotensive episodes monitored by the Acumen IQ® device
Hypotension is defined by the presence of a mean arterial pressure \< 65 mmHg for a minimum duration of 30 seconds. Blood pressure must be invasive and monitored on the HemoSphere® monitor.
Time frame: 72 hours
NE total dose
The NE (norepinephrine) total dose delivered during the research protocol phase (mg/kg) automatically calculated by the DianeRea® software (BowMedical, France).
Time frame: 72 hours
Cumulative diuresis
The Cumulative diuresis (ml.kg.h) during protocol completion (H0 to H72) or when norepinephrine weaning is considered successful.
Time frame: 72 hours
Volume of administrated fluids
Cumulative volume of administration of crystalloids, colloids, or blood products during protocol or when NE weaning is considered as successful.
Time frame: 72 hours
Total dose of vasoactive drugs
Vaso-active drugs. The total dose of vasoactive drug initiation or reintroduction of NE after the weaning protocol calculated by the NEE and the VIS.
Time frame: 72 hours
Number of stroke
Stroke (Any embolic, thrombotic or haemorrhagic cerebral event with persistent residual motor, sensory or cognitive dysfunction (eg, hemiplegia, hemiparesis, aphasia, sensory deficit, impaired memory) diagnosed on a cerebral scanner)
Time frame: 72 hours
Number of myocardial infarction
Myocardial infarction diagnosed by the clinical presentation, serial changes on 12-lead electrocardiographic suggesting infarction, and rise in cardiac markers (preferably cardiac troponins) with at least one value above the 99th percentile of the upper reference limit.
Time frame: 72 hours
Number of resuscitated cardiac arrest
Cessation of mechanical cardiac activity confirmed by the absence of clinical signs of blood flow
Time frame: 72 hours
Number of acute kidney injury
Increase in serum creatinine of over 27 μmol/L within 48 hours or diuresis lower than 0.5 mL/kg/hour (KDIGO Guidelines).
Time frame: 72 hours
Number of mesenteric ischaemia
Mesenteric ischaemia confirmed by imaging or exploratory laparotomy and/or ischaemic colitis confirmed by gastrointestinal endoscopy or exploratory laparotomy
Time frame: 72 hours
Number of in-hospital mortality.
Mortality from surgery to hospital discharge
Time frame: 72 hours
Number of 30 days hospital mortality
Mortality after surgery until 30 days follow-up
Time frame: 30 days
Plan to share: No
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Centre Hospitalier Universitaire, Amiens