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

Blood Pressure, Low Clinical Trial

— INTENS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04934410
• Other study ID #: S-602/2020
• Status: Not yet recruiting
• Start date: November 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2021
• Source: Heidelberg University
• Contact: Adrian E Stephan, MD
• Phone: 004962215636107
• Email: adrian.stephan[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure, Low
• Heart Failure
• Hypotension

Intervention

Drug:
• Etomidate
Use of etomidate during induction as decided by attending anesthesiologist
• Midazolam
Use of midazolam during induction as decided by attending anesthesiologist
• Sevoflurane
Use of sevoflurane during induction as decided by attending anesthesiologist

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Outcome

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