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

NCT04934410 | Unknown FDA Drug

• 1 other identifier: S-602/2020
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Blood Pressure, Low

Keywords

Blood Pressure; Catecholamines; Heart failure; High risk patients; Left ventricular assist device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Antihypotensive drugs after induction

  First 30 minutes after induction of anesthesia

• Antihypotensive drugs during the procedure

  Begin of the procedure until end of the procedure

• Length of stay on the intensive care unit (ICU)

  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

  First 24 hours after the end of the procedure

• Kidney

  First 28 days after procedure

Study Arms (3)

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

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

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

Interventions

Etomidate DRUG

Use of etomidate during induction as decided by attending anesthesiologist

Patients undergoing Implantation of left ventricular assist device (Etomidate)

Midazolam DRUG

Use of midazolam during induction as decided by attending anesthesiologist

Patients undergoing Implantation of left ventricular assist device (Midazolam)

Sevoflurane DRUG

Use of sevoflurane during induction as decided by attending anesthesiologist

Patients undergoing Implantation of left ventricular assist device (Sevoflurane)

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

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Heidelberg University: lead

MeSH Terms

Conditions

Hypotension; Heart Failure

Interventions

Etomidate; Midazolam; Sevoflurane

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Heart Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Adrian E Stephan, MD

  Department of Anesthesiology, Heidelberg University Hospital, Heidelberg, Germany

  STUDY DIRECTOR

Central Study Contacts

Adrian E Stephan, MD

CONTACT

004962215636107; adrian.stephan@med.uni-heidelberg.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: June 22, 2021
• Study Start: November 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 19, 2021

Record last verified: 2021-10