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Search / Trial NCT05922982

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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE, AMIENS · Jun 20, 2023

Trial Information

Current as of August 25, 2025

Recruiting

Keywords

Vasoplegia Shock Hypotension Prediction Index Acumen Cabg Norepinephrine Surgery

ClinConnect Summary

This clinical trial is studying a new way to help patients who experience low blood pressure after heart surgery, a condition known as vasoplegic shock. The researchers are using a device called the Acumen IQ to predict when a patient might have low blood pressure episodes. By using this predictive information, they hope to safely reduce the amount of norepinephrine, a medication commonly used to raise blood pressure, that patients need after their surgery. This trial aims to ensure that patients receive the right amount of medication without risking too much exposure, which can also be harmful.

To be eligible for this trial, participants must be adults over 18 years old who are undergoing specific types of heart surgery and are experiencing low blood pressure after their procedure. Participants will be monitored closely for 30 days after surgery, with follow-up visits to check their health. The trial will last for 72 hours, during which the researchers will gather important information to see if their new approach can help improve patient outcomes after surgery.

Gender

ALL

Eligibility criteria

  • 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

About Centre Hospitalier Universitaire, Amiens

The Centre Hospitalier Universitaire (CHU) Amiens is a leading academic medical center in France dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on multidisciplinary collaboration, CHU Amiens integrates patient care, education, and research to enhance treatment outcomes and improve patient quality of life. The institution is committed to ethical standards and regulatory compliance in its clinical research endeavors, aiming to contribute significantly to the medical community and the development of new therapeutic approaches. By fostering partnerships with various stakeholders, CHU Amiens strives to translate scientific discoveries into practical applications that benefit patients and healthcare systems alike.

Locations

Amiens, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported