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NCT Number: NCT05922982

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

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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Key information

Conditions

Vasoplegia Cardiovascular Diseases Norepinephrine Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Shock Surgery Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens Picardie

Amiens, France

Location status: Recruiting

Location contact

Christophe Beyls, MD

CONTACT

[email protected]

0322087866

Osama Abou Arab, MD

SUB_INVESTIGATOR

Yazine Mahjoub, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

norepinephrine weaning protocol

Drug

MAP-based (MAP > 65 mmHg) norepinephrine weaning protocol

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.

Primary outcomes

  1. Comparison of the duration of norepinephrine administration between both groups

    Time frame: 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 outcomes

  1. Number of norepinephrine protocol weaning failures

    Time frame: 2 years

    Number of norepinephrine protocol weaning failures, defined as persistent norepinephrine delivery 72 hours after the start of inclusion

  2. Prevalence of hypotensive episodes monitored by the Acumen IQ® device

    Time frame: 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.

  3. Frequency of hypotensive episodes monitored by the Acumen IQ® device

    Time frame: 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.

  4. Duration of hypotensive episodes monitored by the Acumen IQ® device

    Time frame: 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.

  5. NE total dose

    Time frame: 72 hours

    The NE (norepinephrine) total dose delivered during the research protocol phase (mg/kg) automatically calculated by the DianeRea® software (BowMedical, France).

  6. Cumulative diuresis

    Time frame: 72 hours

    The Cumulative diuresis (ml.kg.h) during protocol completion (H0 to H72) or when norepinephrine weaning is considered successful.

  7. Volume of administrated fluids

    Time frame: 72 hours

    Cumulative volume of administration of crystalloids, colloids, or blood products during protocol or when NE weaning is considered as successful.

  8. Total dose of vasoactive drugs

    Time frame: 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.

  9. Number of stroke

    Time frame: 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)

  10. Number of myocardial infarction

    Time frame: 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.

  11. Number of resuscitated cardiac arrest

    Time frame: 72 hours

    Cessation of mechanical cardiac activity confirmed by the absence of clinical signs of blood flow

  12. Number of acute kidney injury

    Time frame: 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).

  13. Number of mesenteric ischaemia

    Time frame: 72 hours

    Mesenteric ischaemia confirmed by imaging or exploratory laparotomy and/or ischaemic colitis confirmed by gastrointestinal endoscopy or exploratory laparotomy

  14. Number of in-hospital mortality.

    Time frame: 72 hours

    Mortality from surgery to hospital discharge

  15. Number of 30 days hospital mortality

    Time frame: 30 days

    Mortality after surgery until 30 days follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Christophe Beyls, MD

CONTACT

[email protected]

0322087866

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: NORAHPI

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 28, 2023
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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