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

Study Overview
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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).

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

Conditions
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Blood Pressure, Low

Intervention / Treatment
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* Drug: Etomidate
* Drug: Midazolam
* Drug: Sevoflurane


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing Implantation of left ventricular assist device (Etomidate)<br>High-risk heart-failure patients undergoing the implantation of a left ventricular assist device (LVAD). The induction agent is etomidate. | Drug: Etomidate<br>* Use of etomidate during induction as decided by attending anesthesiologist<br>|
| Patients undergoing Implantation of left ventricular assist device (Midazolam)<br>High-risk heart-failure patients undergoing the implantation of a left ventricular assist device (LVAD). The induction agent is midazolam. | Drug: Midazolam<br>* Use of midazolam during induction as decided by attending anesthesiologist<br>|
| Patients undergoing Implantation of left ventricular assist device (Sevoflurane)<br>High-risk heart-failure patients undergoing the implantation of a left ventricular assist device (LVAD). The induction agent is sevoflurane. | Drug: Sevoflurane<br>* Use of sevoflurane during induction as decided by attending anesthesiologist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-Induction hypotension | The incidence of hypotension in the first 30 minutes after the induction of anesthesia | First 30 minutes after induction of anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antihypotensive drugs after induction | Use of antihypotensive drugs during the first 30 minutes after induction of anesthesia | First 30 minutes after induction of anesthesia | 
| Antihypotensive drugs during the procedure | Use of antihypotensive drugs during the procedure | Begin of the procedure until end of the procedure | 
| 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. | 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 | 
| Delirium | Diagnosis of postoperative delirium | First 24 hours after the end of the procedure | 
| Kidney | Occurrence of acute kidney failure as defined by Kidney Disease: Improving Global Outcomes (KDIGO) | First 28 days after procedure | 
| Mortality | Mortalitiy in the first 28 days after the procedure | First 28 days after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Pressure, Catecholamines, Heart failure, High risk patients, Left ventricular assist device