Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05922982

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

Led by Centre Hospitalier Universitaire, Amiens · Updated on 2024-07-03

142

Participants Needed

1

Research Sites

95 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Hospitalized in the cardiothoracic-vascular and respiratory intensive care unit of Amiens-Picardy University Hospital
  • Scheduled for on-pump cardiac surgery such as coronary artery bypass grafting, valve replacement, ascending aorta replacement, or combined surgery
  • Started norepinephrine after surgery to treat vasoplegic syndrome
  • Cardiac surgery performed less than 48 hours ago
  • Hemodynamically stable with mean arterial pressure over 65 mmHg for more than 4 hours while on norepinephrine
  • Mean arterial pressure monitored via radial or femoral arterial catheter
  • Has social security coverage
  • Provided signed consent to participate before surgery
Not Eligible

You will not qualify if you...

  • Permanent arrhythmia such as atrial fibrillation, flutter, or frequent atrial extrasystoles
  • Receiving treatment with dobutamine, epinephrine, or vasopressin analogs
  • Preoperative chronic end-stage renal failure requiring extra-renal purification after surgery
  • Pregnant
  • Dependent on an internal or external pacemaker
  • Body temperature below 36 degrees Celsius (hypothermia)
  • On mechanical circulatory assistance after cardiac surgery
  • Experiencing hemorrhagic shock
  • Under guardianship or curatorship

AI-Screening

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Trial Site Locations

Total: 1 location

1

CHU Amiens Picardie

Amiens, France

Actively Recruiting

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Research Team

C

Christophe Beyls, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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