Norepinephrine Bolus to Tackle Post-Induction Hypotension in Heart Failure Patients Under General Anesthesia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study looks at whether a diluted norepinephrine bolus can improve cardiac output in patients with chronic heart failure who experience arterial hypotension after induction of general anesthesia. Cardiac output monitoring will be performed using the Starling SV Sebac device. The study population is adults with heart failure (LVEF ≤40%) undergoing planned surgery under general anesthesia, with invasive hemodynamic monitoring in place and postoperative ICU follow-up. The investigation aims to describe the hemodynamic impact of norepinephrine and inform perioperative management in this high-risk group.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult patients
* Heart failure patients with left ventricular failure with a ventricular ejection fraction less than or equal to 40% evaluated by trans-thoracic echocardiography less than a year ago and specifying in particular the patient's filling pressures at the state stable.
* Patients under treatment adapted to the level of heart failure according to the 2021 European Society of Cardiology recommendations.
* Scheduled surgery under general anesthesia.
* Invasive hemodynamic monitoring planned by the anesthetist-resuscitator (irrespective of potential inclusion in the protocol): arterial catheter and central venous line for measurement of CVP (central venous pressure).
* Postoperative monitoring planned in intensive care or intensive care
* Presence of controlled mechanical ventilation with tidal volumes between 8 and 10 ml/kg of ideal weight.
* Presence of arterial hypotension after induction of general anesthesia, and before surgical stimulation.
* Patient affiliated to a social security scheme or equivalent
* No opposition from the patient.

Exclusion Criteria:

* Chronic heart failure patients with right ventricular failure.
* Patients presenting signs of acute pulmonary edema, Pulmonary arterial hypertension (PAH), severe valvular disease, intracardiac shunt.
* Patients operated on under general anesthesia but maintaining spontaneous ventilation.
* Patients with respiratory compliance disorders with compliances greater than 30 cm of water.
* Patients with intra-abdominal hypertension.
* Patients with supraventricular or ventricular arrhythmia.
* Patients treated with catecholamines prior to the procedure.
* Patients operated on for urgent surgeries
* Patient under guardianship, curatorship or safeguard of justice
* Pregnant or breastfeeding women.

Where it's running

• CHU Toulouse Rangueil
  Toulouse, France Recruiting

Study contacts

• Principal investigator: François LABASTE, Dr — University Hospital, Toulouse
• Study coordinator: François LABASTE, Dr
• Email: labaste.f@chu-toulouse.fr
• Phone: 0561322822

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.