Guiding norepinephrine weaning in patients with vasoplegic shock after heart surgery
Norepinephrine Weaning Guided by the Hypotension Prediction Index in Vasoplegic Shock After Cardiac Surgery
This study is testing whether using a special tool to guide how doctors reduce norepinephrine can help patients recovering from heart surgery with low blood pressure do better than those who get standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 142 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT05922982 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of the Hypotension Prediction Index (HPI) to guide the weaning of norepinephrine in patients experiencing vasoplegic shock following cardiac surgery. The study involves a single-center, prospective, open-label, randomized, controlled design, where patients will be divided into two groups: one receiving standard norepinephrine weaning and the other guided by the HPI. The aim is to reduce the duration and dosage of norepinephrine while preventing episodes of arterial hypotension. The trial will monitor patients' mean arterial pressure (MAP) to assess the effectiveness of the HPI in managing their condition.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have undergone on-pump cardiac surgery and are experiencing vasoplegic syndrome requiring norepinephrine treatment.
Not a fit: Patients with permanent arrhythmias or those receiving other specific treatments like dobutamine or epinephrine may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of vasoplegic shock, reducing morbidity and mortality in postoperative cardiac surgery patients.
How similar studies have performed: While the use of predictive indices in managing hypotension is an emerging field, this specific approach using the HPI in the context of vasoplegic shock is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amiens
- CHU Amiens Picardie — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Christophe Beyls, MD
- Email: beyls.christophe@chu-amiens.fr
- Phone: 0322087866
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.