Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients

NCT06350929 | Not Yet Recruiting

• 1 other identifier: RC31/24/0017
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Arterial hypotension is a frequent complication of general anesthesia and a significant contributor to postoperative complications. It is a critical marker for the development of acute renal failure and postoperative myocardial infarction. Chronic heart failure (CHF) patients are increasingly encountered in the operating room, and their perioperative morbidity and mortality are substantial, with specific management lacking precise recommendations. The main objective is to assess the impact of a diluted norepinephrine bolus on cardiac output in chronic heart failure patients experiencing arterial hypotension after anesthesia induction.

Conditions

Hypotension

Keywords

Chronic heart failure; Norepinephrine; General anaesthesia

Outcome Measures

Primary Outcomes (1)

• Evaluation of the impact of a bolus of diluted norepinephrine on cardiac output in chronic heart failure patients presenting with arterial hypotension after anesthetic induction.

  The evolution of the value of cardiac output assessed by non-invasive monitoring, using bioreactance: Starling™ SV Sebac®.

  During the surgery.

Secondary Outcomes (4)

• Evaluation of the role of preload dependence before anesthetic induction in the variation of cardiac output after a norepinephrine bolus.

  During the surgery.

• Evaluation of the impact of the norepinephrine bolus on blood pressure correction.

  During the surgery.

• Evaluation of the impact of the norepinephrine bolus on heart rate.

  During the surgery.

• Evaluation of the safety of use of norepinephrine in chronic heart failure patients during hospitalization.

  For 10 days after surgery.

Study Arms (1)

Research procedures

Patients with heart failure

Other: Cardiac output monitoring by the Starling™ SV Sebac®

Interventions

Cardiac output monitoring by the Starling™ SV Sebac® OTHER

During the surgery, the channels and monitoring equipment will be set up according to the usual procedure in the vascular surgery department. As part of the research, the Starling™ SV Sebac® electrodes will be installed (to measure cardiac flow, cardiac index (CI), stroke volume (VES), variations in stroke volume (VVES), and peripheral resistors (TPRI)). Once the equipment is in place, anesthetic induction will be carried out according to the usual protocol with curarization and mechanical ventilation. If the appearance of arterial hypotension is noted after anesthetic induction and mechanical ventilation, the patient will be definitively included in the study. As recommended, he will receive norepinephrine to treat hypotension. The measurements from the monitoring will be collected at 3, 5, and 10 min after the administration of norepinephrine. 10 days after admission to the operating room, hospitalization data will be collected.

Research procedures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes patients with heart failure and left ventricular failure with a ventricular ejection fraction less than or equal to 40%.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU Toulouse Rangueil

Toulouse, 31400, France

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• François LABASTE, Dr

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

François LABASTE, Dr

CONTACT

0561322822; labaste.f@chu-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 8, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)