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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04934410
Acronym
INTENS
Enrollment
50
Registered
2021-06-22
Start date
2021-11-01
Completion date
2022-12-31
Last updated
2021-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, Low

Keywords

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

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).

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

Sponsors

Heidelberg University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Post-Induction hypotensionFirst 30 minutes after induction of anesthesiaThe incidence of hypotension in the first 30 minutes after the induction of anesthesia

Secondary

MeasureTime frameDescription
Antihypotensive drugs during the procedureBegin of the procedure until end of the procedureUse of antihypotensive drugs during 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.CUThe time the patient has to be treated on intensive care unit after the procedure (in hours) before submission.
Antihypotensive drugs after inductionFirst 30 minutes after induction of anesthesiaUse of antihypotensive drugs during the first 30 minutes after induction of anesthesia
KidneyFirst 28 days after procedureOccurrence of acute kidney failure as defined by Kidney Disease: Improving Global Outcomes (KDIGO)
MortalityFirst 28 days after procedureMortalitiy in the first 28 days after the procedure
DeliriumFirst 24 hours after the end of the procedureDiagnosis of postoperative delirium

Contacts

Primary ContactAdrian E Stephan, MD
adrian.stephan@med.uni-heidelberg.de004962215636107

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026