BridgeMD
New treatment option for Vasoplegia
Official title Norepinephrine Weaning Guided by the Hypotension Prediction Index in Vasoplegic Shock After Cardiac Surgery
ClinicalTrials.gov ID: NCT05922982
What this study is testing
What is norepinephrine weaning protocol?
norepinephrine weaning protocol is an investigational medicine, being studied as a potential treatment for vasoplegia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Introduction of norepinephrine post-surgery for the treatment of vasoplegic syndrome.
- On-pomp cardiac surgery in less than 48 hours.
You likely can't join if
- 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°.
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.