Norepinephrine, Shock, Surgery, Vasoplegia
Conditions
Keywords
vasoplegia, shock, hypotension prediction index, Acumen, CABG, norepinephrine, surgery
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.
Interventions
DRUGnorepinephrine weaning protocol
MAP-based (MAP \> 65 mmHg) norepinephrine weaning protocol
DRUGnorepinephrine weaning protocol and guided by the HPI
MAP-based (MAP \> 65 mmHg) norepinephrine weaning protocol and guided by the HPI (HPI\<80) delivered by the Acumen IQ medical device.
Sponsors
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the duration of norepinephrine administration between both groups | 72 hours | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of in-hospital mortality. | 72 hours | Mortality from surgery to hospital discharge |
| Number of 30 days hospital mortality | 30 days | Mortality after surgery until 30 days follow-up |
| Number of norepinephrine protocol weaning failures | 2 years | Number of norepinephrine protocol weaning failures, defined as persistent norepinephrine delivery 72 hours after the start of inclusion |
| Prevalence of hypotensive episodes monitored by the Acumen IQ® device | 72 hours | 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. |
| Frequency of hypotensive episodes monitored by the Acumen IQ® device | 72 hours | 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. |
| Duration of hypotensive episodes monitored by the Acumen IQ® device | 72 hours | 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. |
| NE total dose | 72 hours | The NE (norepinephrine) total dose delivered during the research protocol phase (mg/kg) automatically calculated by the DianeRea® software (BowMedical, France). |
| Number of mesenteric ischaemia | 72 hours | Mesenteric ischaemia confirmed by imaging or exploratory laparotomy and/or ischaemic colitis confirmed by gastrointestinal endoscopy or exploratory laparotomy |
| Volume of administrated fluids | 72 hours | Cumulative volume of administration of crystalloids, colloids, or blood products during protocol or when NE weaning is considered as successful. |
| Total dose of vasoactive drugs | 72 hours | 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. |
| Number of stroke | 72 hours | 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) |
| Number of myocardial infarction | 72 hours | 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. |
| Number of resuscitated cardiac arrest | 72 hours | Cessation of mechanical cardiac activity confirmed by the absence of clinical signs of blood flow |
| Number of acute kidney injury | 72 hours | Increase in serum creatinine of over 27 μmol/L within 48 hours or diuresis lower than 0.5 mL/kg/hour (KDIGO Guidelines). |
| Cumulative diuresis | 72 hours | The Cumulative diuresis (ml.kg.h) during protocol completion (H0 to H72) or when norepinephrine weaning is considered successful. |
Countries
France
Contacts
Primary ContactChristophe Beyls, MD
Outcome results
None listed