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

October 17, 2021 updated by: Dr. Adrian Stephan, Heidelberg University

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with terminal heart failure which are scheduled for implantation of a left ventricular assist device (LVAD)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Post-Induction hypotension
Time Frame: First 30 minutes after induction of anesthesia
The incidence of hypotension in the first 30 minutes after the induction of anesthesia
First 30 minutes after induction of anesthesia

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Antihypotensive drugs after induction
Time Frame: First 30 minutes after induction of anesthesia
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
Time Frame: Begin of the procedure until end of 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)
Time Frame: 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.
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
Time Frame: First 24 hours after the end of the procedure
Diagnosis of postoperative delirium
First 24 hours after the end of the procedure
Kidney
Time Frame: First 28 days after procedure
Occurrence of acute kidney failure as defined by Kidney Disease: Improving Global Outcomes (KDIGO)
First 28 days after procedure
Mortality
Time Frame: First 28 days after procedure
Mortalitiy in the first 28 days after the procedure
First 28 days after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Heidelberg University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Adrian E Stephan, MD, Department of Anesthesiology, Heidelberg University Hospital, Heidelberg, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S-602/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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