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

• Sponsor: Heidelberg University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04934410
• Collaborator: (none)
• Enrollment: 50
• Anticipated Duration (Months): 14

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Blood Pressure, Low	Drug: Etomidate; Drug: Midazolam; Drug: Sevoflurane

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Induction Agent and Incidence of Hypotension in Heart Failure Patients Undergoing LVAD-Implantation
• Anticipated Study Start Date: Nov 1, 2021
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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; Use of etomidate during induction as decided by attending anesthesiologist
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; Use of midazolam during induction as decided by attending anesthesiologist
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; Use of sevoflurane during induction as decided by attending anesthesiologist

Outcome Measures

Primary Outcome Measures

1. 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

1. Antihypotensive drugs after induction [First 30 minutes after induction of anesthesia]

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

2. Antihypotensive drugs during the procedure [Begin of the procedure until end of the procedure]

   Use of antihypotensive drugs during the procedure

3. 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.

4. Delirium [First 24 hours after the end of the procedure]

   Diagnosis of postoperative delirium

5. Kidney [First 28 days after procedure]

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

6. Mortality [First 28 days after procedure]

   Mortalitiy in the first 28 days after the procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Heidelberg University

Investigators

• Study Director: Adrian E Stephan, MD, Department of Anesthesiology, Heidelberg University Hospital, Heidelberg, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Adrian Stephan, Principal Investigator, Heidelberg University
• ClinicalTrials.gov Identifier: NCT04934410
• Other Study ID Numbers: S-602/2020
• First Posted: Jun 22, 2021
• Last Update Posted: Oct 19, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Keywords provided by Dr. Adrian Stephan, Principal Investigator, Heidelberg University: Blood Pressure; Catecholamines; Heart failure; High risk patients; Left ventricular assist device
• Additional relevant MeSH terms: Heart Failure; Hypotension; Midazolam; Etomidate; Sevoflurane

Study Results

No Results Posted as of Oct 19, 2021