Induction Agent and Incidence of Hypotension in Heart Failure Patients Undergoing LVAD-Implantation (INTENS)

The induction of anesthesia is one of the most critical situations for high-risk-patients undergoing major surgery. For several reasons, it is crucial to maintain adequate blood pressure and cardiac output during this phase.

This observational study aims to find out if the choice of the induction agent has a major impact on blood pressure and the use of antihypotensive drugs during the induction and the surgical procedure in heart-failure patients undergoing the implantation of a left ventricular assist device (LVAD).

Study Overview

• Status: Not yet recruiting
• Conditions: Blood Pressure, Low
• Intervention / Treatment: Drug: Etomidate; Drug: Midazolam; Drug: Sevoflurane

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

Contacts and Locations

• Study Contact: Name: Adrian E Stephan, MD; Phone Number: 004962215636107; Email: adrian.stephan@med.uni-heidelberg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with terminal heart failure which are scheduled for implantation of a left ventricular assist device (LVAD)

Description

Inclusion Criteria:

- Heart failure patients scheduled for implantation of left ventricular assist device (LVAD)

Exclusion Criteria:

• Pregnancy
• Presence of another cardiac assist device in the patient (for example ECLS)
• No consent of the patient

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing Implantation of left ventricular assist device (Etomidate); High-risk heart-failure patients undergoing the implantation of a left ventricular assist device (LVAD). The induction agent is etomidate.	Drug: Etomidate; Use of etomidate during induction as decided by attending anesthesiologist
Patients undergoing Implantation of left ventricular assist device (Midazolam); High-risk heart-failure patients undergoing the implantation of a left ventricular assist device (LVAD). The induction agent is midazolam.	Drug: Midazolam; Use of midazolam during induction as decided by attending anesthesiologist
Patients undergoing Implantation of left ventricular assist device (Sevoflurane); High-risk heart-failure patients undergoing the implantation of a left ventricular assist device (LVAD). The induction agent is sevoflurane.	Drug: Sevoflurane; Use of sevoflurane during induction as decided by attending anesthesiologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Induction hypotension	The incidence of hypotension in the first 30 minutes after the induction of anesthesia	First 30 minutes after induction of anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antihypotensive drugs after induction	Use of antihypotensive drugs during the first 30 minutes after induction of anesthesia	First 30 minutes after induction of anesthesia
Antihypotensive drugs during the procedure	Use of antihypotensive drugs during the procedure	Begin of the procedure until end of the procedure
Length of stay on the intensive care unit (ICU)	The time the patient has to be treated on intensive care unit after the procedure (in hours) before submission.	After the procedure and transport to intensive care unit, total time in hours until submission from I. Expected time frame is 48 to 96 hours.CU
Delirium	Diagnosis of postoperative delirium	First 24 hours after the end of the procedure
Kidney	Occurrence of acute kidney failure as defined by Kidney Disease: Improving Global Outcomes (KDIGO)	First 28 days after procedure
Mortality	Mortalitiy in the first 28 days after the procedure	First 28 days after procedure

Collaborators and Investigators

• Sponsor: Heidelberg University
• Investigators: Study Director: Adrian E Stephan, MD, Department of Anesthesiology, Heidelberg University Hospital, Heidelberg, Germany

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: June 20, 2021
• First Posted (ACTUAL): June 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 17, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Heart failure; Blood Pressure; Catecholamines; High risk patients; Left ventricular assist device
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Heart Failure; Hypotension; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anesthetics, Inhalation; Midazolam; Sevoflurane; Etomidate
• Other Study ID Numbers: S-602/2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes