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

NCT ID: NCT04934410

Last Updated: 2021-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Blood Pressure, Low

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Etomidate

Intervention Type DRUG

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.

Midazolam

Intervention Type DRUG

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.

Sevoflurane

Intervention Type DRUG

Use of sevoflurane during induction as decided by attending anesthesiologist

Interventions

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Etomidate

Use of etomidate during induction as decided by attending anesthesiologist

Intervention Type DRUG

Midazolam

Use of midazolam during induction as decided by attending anesthesiologist

Intervention Type DRUG

Sevoflurane

Use of sevoflurane during induction as decided by attending anesthesiologist

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Adrian Stephan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adrian E Stephan, MD

Role: STUDY_DIRECTOR

Department of Anesthesiology, Heidelberg University Hospital, Heidelberg, Germany

Central Contacts

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Adrian E Stephan, MD

Role: CONTACT

004962215636107

Other Identifiers

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S-602/2020

Identifier Type: -

Identifier Source: org_study_id