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Status unknownNCT04934410INTENSUpdated Oct 19, 2021

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

An observational study in Blood Pressure, Low, sponsored by Heidelberg University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-19.

Sponsored by Heidelberg University · Observational

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
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Study 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).

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Conditions studied

  • Blood Pressure, Low

Keywords

  • Blood Pressure
  • Catecholamines
  • Heart failure
  • High risk patients
  • Left ventricular assist device
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In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 50 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Heidelberg University is the lead sponsor of 279 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DrugEtomidate

    Use of etomidate during induction as decided by attending anesthesiologist

  • DrugMidazolam

    Use of midazolam during induction as decided by attending anesthesiologist

  • DrugSevoflurane

    Use of sevoflurane during induction as decided by attending anesthesiologist

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What researchers measure

Primary outcomes

  1. Post-Induction hypotension

    The incidence of hypotension in the first 30 minutes after the induction of anesthesia

    Time frame: First 30 minutes after induction of anesthesia

Secondary outcomes

  1. Antihypotensive drugs after induction

    Use of antihypotensive drugs during the first 30 minutes after induction of anesthesia

    Time frame: First 30 minutes after induction of anesthesia

  2. Antihypotensive drugs during the procedure

    Use of antihypotensive drugs during the procedure

    Time frame: Begin of the procedure until end of the procedure

  3. 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.

    Time frame: 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

  4. Delirium

    Diagnosis of postoperative delirium

    Time frame: First 24 hours after the end of the procedure

  5. Kidney

    Occurrence of acute kidney failure as defined by Kidney Disease: Improving Global Outcomes (KDIGO)

    Time frame: First 28 days after procedure

  6. Mortality

    Mortalitiy in the first 28 days after the procedure

    Time frame: First 28 days after procedure

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04934410
Lead sponsor
Heidelberg University
Responsible party
Dr. Adrian Stephan (Principal Investigator, Heidelberg University) — Principal investigator
First posted
Jun 22, 2021
Start date
Nov 1, 2021 (estimated)
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Oct 19, 2021

Study contacts

Adrian E Stephan, MD
Contact
adrian.stephan@med.uni-heidelberg.de
004962215636107
Adrian E Stephan, MD
study director · Department of Anesthesiology, Heidelberg University Hospital, Heidelberg, Germany

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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