Norepinephrine Weaning Guided by the Hypotension Prediction Index in Vasoplegic Shock After Cardiac Surgery

Surgery Clinical Trial

— NORAHPI  

Official title:

Norepinephrine Weaning Guided by the Hypotension Prediction Index in Vasoplegic Shock After Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05922982
• Other study ID #: PI2023_843_0046
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: July 2025

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Christophe Beyls, MD
• Phone: 0322087866
• Email: beyls.christophe[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: July 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Shock
• Surgery
• Vasoplegia

Intervention

Drug:
• norepinephrine weaning protocol
MAP-based (MAP > 65 mmHg) norepinephrine weaning protocol
• norepinephrine 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.

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	72 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	Cumulative diuresis	The Cumulative diuresis (ml.kg.h) during protocol completion (H0 to H72) or when norepinephrine weaning is considered successful.	72 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of resuscitated cardiac arrest	Cessation of mechanical cardiac activity confirmed by the absence of clinical signs of blood flow	72 hours
Secondary	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
Secondary	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
Secondary	Number of in-hospital mortality.	Mortality from surgery to hospital discharge	72 hours
Secondary	Number of 30 days hospital mortality	Mortality after surgery until 30 days follow-up	30 days