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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care arm | Active Comparator | MAP-based (MAP > 65 mmHg) norepinephrine weaning protocol |
|
| Experimental arm (HPI-guided) | Experimental | MAP-based (MAP > 65 mmHg) norepinephrine weaning protocol and guided by the HPI (HPI<80) delivered by the Acumen IQ medical device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| norepinephrine weaning protocol | Drug | MAP-based (MAP > 65 mmHg) norepinephrine weaning protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of norepinephrine protocol weaning failures | Number of norepinephrine protocol weaning failures, defined as persistent norepinephrine delivery 72 hours after the start of inclusion | 2 years |
| Prevalence of hypotensive episodes monitored by the Acumen IQ® device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christophe Beyls, MD | Contact | 0322087866 | beyls.christophe@chu-amiens.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens Picardie | Recruiting | Amiens | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38926148 | Derived | Beyls C, Lefebvre T, Mollet N, Boussault A, Meynier J, Abou-Arab O, Mahjoub Y. 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. BMJ Open. 2024 Jun 26;14(6):e084499. doi: 10.1136/bmjopen-2024-084499. |
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| norepinephrine weaning protocol and guided by the HPI | Drug | MAP-based (MAP > 65 mmHg) norepinephrine weaning protocol and guided by the HPI (HPI<80) delivered by the Acumen IQ medical 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. |
| 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. | 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. | 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). | 72 hours |
| Cumulative diuresis | The Cumulative diuresis (ml.kg.h) during protocol completion (H0 to H72) or when norepinephrine weaning is considered successful. | 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. | 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. | 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) | 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. | 72 hours |
| Number of resuscitated cardiac arrest | Cessation of mechanical cardiac activity confirmed by the absence of clinical signs of blood flow | 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). | 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 | 72 hours |
| Number of in-hospital mortality. | Mortality from surgery to hospital discharge | 72 hours |
| Number of 30 days hospital mortality | Mortality after surgery until 30 days follow-up | 30 days |
| ID | Term |
|---|---|
| D056987 | Vasoplegia |
| D012769 | Shock |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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