Blood Pressure, LowINTENSNCT04934410
Induction Agent and Incidence of Hypotension in Heart Failure Patients Undergoing LVAD-Implantation
An observational study of Blood Pressure, Low, run by Heidelberg University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure, Low
- What is being tested?
- Etomidate, Midazolam and Sevoflurane
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with terminal heart failure which are scheduled for implantation of a left ventricular assist device (LVAD)
Who may be able to join
- Heart failure patients scheduled for implantation of left ventricular assist device (LVAD)
Who cannot join
- Pregnancy
- Presence of another cardiac assist device in the patient (for example ECLS)
- No consent of the patient
Trial locations and contacts
No sites are listed yet.
About this study
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).
- Conditions
- Blood Pressure, Low
- Being tested
- Etomidate, Midazolam, Sevoflurane
- Keywords
- Blood Pressure, Catecholamines, Heart failure, High risk patients, Left ventricular assist device
- Medical subject headings
- Hypotension, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtomidateDrug
Use of etomidate during induction as decided by attending anesthesiologist
MidazolamDrug
Use of midazolam during induction as decided by attending anesthesiologist
SevofluraneDrug
Use of sevoflurane during induction as decided by attending anesthesiologist
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Etomidate | |
| 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. Receives: Drug: Midazolam | |
| 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. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Induction hypotension
The incidence of hypotension in the first 30 minutes after the induction of anesthesia
Measured: First 30 minutes after induction of anesthesia
Secondary outcomes (6)
Antihypotensive drugs after induction
Use of antihypotensive drugs during the first 30 minutes after induction of anesthesia
Measured: First 30 minutes after induction of anesthesia
Antihypotensive drugs during the procedure
Use of antihypotensive drugs during the procedure
Measured: 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.
Measured: 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
Measured: First 24 hours after the end of the procedure
Kidney
Occurrence of acute kidney failure as defined by Kidney Disease: Improving Global Outcomes (KDIGO)
Measured: First 28 days after procedure
Mortality
Mortalitiy in the first 28 days after the procedure
Measured: First 28 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start1 Nov 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Pressure, LowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Adrian Stephan, Heidelberg University
- Investigators
- Adrian E Stephan, MD, Study director, Department of Anesthesiology, Heidelberg University Hospital, Heidelberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934410
- Sponsor's protocol ID
- S-602/2020
- Acronym
- INTENS
- Status last verified
- Oct 2021
- First submitted
- 29 Jan 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction Agent and Incidence of Hypotension in Heart Failure Patients Undergoing LVAD-Implantation
- ClinicalTrials.gov ID
- NCT04934410
- Acronym / sponsor ID
- INTENS / S-602/2020
- Conditions
- Blood Pressure, Low
- Keywords
- Blood Pressure, Catecholamines, Heart failure, High risk patients, Left ventricular assist device
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 22 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing Implantation of left ventricular assist device (Etomidate) | – | Drug: EtomidateHigh-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) | – | Drug: MidazolamHigh-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) | – | Drug: SevofluraneHigh-risk heart-failure patients undergoing the implantation of a left ventricular assist device (LVAD). The induction agent is sevoflurane. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with terminal heart failure which are scheduled for implantation of a left ventricular assist device (LVAD)
Key inclusion criteria (1 listed)
- Heart failure patients scheduled for implantation of left ventricular assist device (LVAD)
Key exclusion criteria (3 listed)
- Pregnancy
- Presence of another cardiac assist device in the patient (for example ECLS)
- No consent of the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtomidateUse of etomidate during induction as decided by attending anesthesiologist | Drug | Patients undergoing Implantation of left ventricular assist device (Etomidate) |
| MidazolamUse of midazolam during induction as decided by attending anesthesiologist | Drug | Patients undergoing Implantation of left ventricular assist device (Midazolam) |
| SevofluraneUse of sevoflurane during induction as decided by attending anesthesiologist | Drug | Patients undergoing Implantation of left ventricular assist device (Sevoflurane) |
Primary outcome
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
6 secondary outcomes
Antihypotensive drugs after induction
Time frame: First 30 minutes after induction of anesthesia
Antihypotensive drugs during the procedure
Time frame: 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
Delirium
Time frame: First 24 hours after the end of the procedure
Kidney
Time frame: First 28 days after procedure
Mortality
Time frame: First 28 days after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
Related trials for Blood Pressure, Low
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
RecruitingPhase 4
Remimazolam Versus Propofol for Maintenance of Anaesthesia During Major Hepatectomy Under Low Central Venous Pressure
Intraoperative Hypotension, Hepatectomy
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruitingObservational study
Postprandial Hypotension, Frailty and Post-Induction Hypotension in Older Patients Undergoing Noncardiac Surgery
Post-induction Hypotension (PIH), Postprandial Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian E Stephan, MD study director
Department of Anesthesiology, Heidelberg University Hospital, Heidelberg, Germany
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, Low, run by Heidelberg University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adrian E Stephan, MD (004962215636107, adrian.stephan@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Induction hypotension (time frame: First 30 minutes after induction of anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.