Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05922982

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

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients who develop vasoplegic syndrome, a condition causing low blood pressure after cardiac surgery involving extracorporeal circulation. This condition is linked to increased risk after surgery, and current guidelines recommend norepinephrine as a first treatment to reduce complications. However, too much or prolonged use of norepinephrine can also cause harm. This trial evaluates whether using a new monitoring device, the Acumen IQ, which predicts low blood pressure episodes, can improve how norepinephrine is reduced in these patients. The study compares two groups of patients after cardiac surgery: one group follows a standard norepinephrine weaning protocol based on maintaining mean arterial pressure (MAP) above 65 mmHg, while the other group uses the same protocol guided additionally by the Hypotension Prediction Index (HPI) from the Acumen IQ device. This device predicts arterial hypotension episodes by calculating HPI values and helps detect when patients are dependent on blood volume. The interventional treatment period lasts 72 hours, with follow-up visits at the end of the protocol, at hospital discharge, and 30 days after inclusion to collect clinical and biological data. Participants are monitored closely with arterial catheters to measure blood pressure and receive norepinephrine as needed. Researchers will track the duration of norepinephrine administration, frequency and duration of hypotensive episodes, fluid volumes given, and occurrences of complications such as stroke or kidney injury. The study lasts 30 days total to assess the clinical impact of the protocol, including mortality. The aim is to see if HPI guidance can safely reduce norepinephrine use and improve patient outcomes after cardiac surgery.

CONDITIONS

Brief 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 at Amiens-Picardy University Hospital
  • Scheduled for on-pump cardiac surgery such as coronary artery bypass grafting, valve replacement, ascending aorta replacement, or combined surgery
  • Receiving norepinephrine after surgery to treat vasoplegic syndrome
  • Cardiac surgery performed less than 48 hours before inclusion
  • Hemodynamically stable with mean arterial pressure above 65 mmHg for more than 4 hours while on norepinephrine
  • Monitoring of mean arterial pressure using a radial or femoral arterial catheter
  • Social security beneficiary
  • Signed informed consent before surgery
Not Eligible

You will not qualify if you...

  • Permanent arrhythmia such as atrial fibrillation, flutter, or frequent atrial extrasystoles
  • Treatment with dobutamine, epinephrine, or vasopressin analogs
  • Preoperative chronic end-stage renal failure requiring postoperative dialysis
  • Pregnant women
  • Dependence on an internal or external pacemaker
  • Hypothermia below 36 degrees Celsius
  • Mechanical circulatory assistance after cardiac surgery
  • Hemorrhagic shock
  • Under legal guardianship or curatorship

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 72 hours

Participants receive a norepinephrine weaning protocol after cardiac surgery to treat vasoplegic syndrome, guided either by standard MAP-based protocol or by the Hypotension Prediction Index using the Acumen IQ medical device.

Continuous monitoring during ICU stay

Trial Site Locations

Total: 1 location

1

CHU Amiens Picardie

Amiens, France

Actively Recruiting

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Research Team

C

Christophe Beyls, MD

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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Published Research Related To This Trial

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.

Christophe Beyls, Thomas Lefebvre, Nicolas Mollet...

https://pubmed.ncbi.nlm.nih.gov/38926148