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

H

Heidelberg University

Status

Unknown

Conditions

Blood Pressure, Low

Treatments

Drug: Sevoflurane
Drug: Midazolam
Drug: Etomidate

Study type

Observational

Funder types

Other

Identifiers

NCT04934410
S-602/2020

Details and patient eligibility

About

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).

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

50 participants in 3 patient groups

Patients undergoing Implantation of left ventricular assist device (Etomidate)
Description:
High-risk heart-failure patients undergoing the implantation of a left ventricular assist device (LVAD). The induction agent is etomidate.
Treatment:
Drug: Etomidate
Patients undergoing Implantation of left ventricular assist device (Midazolam)
Description:
High-risk heart-failure patients undergoing the implantation of a left ventricular assist device (LVAD). The induction agent is midazolam.
Treatment:
Drug: Midazolam
Patients undergoing Implantation of left ventricular assist device (Sevoflurane)
Description:
High-risk heart-failure patients undergoing the implantation of a left ventricular assist device (LVAD). The induction agent is sevoflurane.
Treatment:
Drug: Sevoflurane

Trial contacts and locations

0

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Central trial contact

Adrian E Stephan, MD

Data sourced from clinicaltrials.gov

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