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

• Conditions: Blood Pressure, Low
• Interventions: Drug: Etomidate; Drug: Midazolam; Drug: Sevoflurane

• Registration Number: NCT04934410
• Lead Sponsor: Heidelberg University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-06-20
• Study First Posted: 2021-06-22
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-17
• Last Update Posted: 2021-10-19
• Study Start: 2021-11-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Post-Induction hypotension	First 30 minutes after induction of anesthesia	The incidence of hypotension in the first 30 minutes after the induction of anesthesia

Secondary Outcome Measures

Name	Time	Method
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	The time the patient has to be treated on intensive care unit after the procedure (in hours) before submission.
Antihypotensive drugs during the procedure	Begin of the procedure until end of the procedure	Use of antihypotensive drugs during the procedure
Kidney	First 28 days after procedure	Occurrence of acute kidney failure as defined by Kidney Disease: Improving Global Outcomes (KDIGO)
Antihypotensive drugs after induction	First 30 minutes after induction of anesthesia	Use of antihypotensive drugs during the first 30 minutes after induction of anesthesia
Mortality	First 28 days after procedure	Mortalitiy in the first 28 days after the procedure
Delirium	First 24 hours after the end of the procedure	Diagnosis of postoperative delirium