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

Evaluation of Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients in the Operating Room.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypotension
• Intervention / Treatment: Other: Cardiac output monitoring by the Starling™ SV Sebac®

Detailed Description

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 potential indications for norepinephrine use are expanding due to dilution methods allowing peripheral catheter administration, particularly for addressing arterial hypotension during general anesthesia induction. However, these indications are primarily based on common practices, and the impact of norepinephrine on cardiac output in patients with chronic heart failure is poorly understood. 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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: François LABASTE, Dr; Phone Number: +33 0561322822; Email: labaste.f@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31400
    • CHU TOULOUSE Rangueil
    • Contact: François LABASTE, Dr; Phone Number: +33 0561322822; Email: labaste.f@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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%.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Research procedures; Patients with heart failure

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the role of preload dependence before anesthetic induction in the variation of cardiac output after a norepinephrine bolus.	Measurement of pulse pressure difference.	During the surgery.
Evaluation of the impact of the norepinephrine bolus on blood pressure correction.	Evolution of the monitoring data: systolic blood pressure (SBP - mmHg).	During the surgery.
Evaluation of the impact of the norepinephrine bolus on heart rate.	Evolution of the monitoring data: heart rate (HR - bpm).	During the surgery.
Evaluation of the safety of use of norepinephrine in chronic heart failure patients during hospitalization.	Monitoring the appearance of side effects during post-operative hospitalization on the assessments usually carried out in the department and including.	For 10 days after surgery.

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: François LABASTE, Dr, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Norepinephrine; General anaesthesia; Chronic heart failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Heart Failure; Hypotension
• Other Study ID Numbers: RC31/24/0017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No