Left Ventricular Diastolic DysfunctionNCT03522194
Left Ventricular Diastolic Function During Anesthesia Induction
An observational study of Left Ventricular Diastolic Dysfunction, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Diastolic dysfunction is an important cause of hemodynamic instability in the perioperative field.Therefore this study aims to investigate the influence of existing diastolic dysfunction or deterioration of diastolic function on hemodynamic stability during induction of anesthesia and postoperative complications. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Left Ventricular Diastolic Dysfunction
- What is being tested?
- Sevoflurane and Propofol
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2017to 27 Sep 2018
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients scheduled for surgery under general anesthesia
Who may be able to join
- Patients older than 60 years scheduled for general anesthesia
Who cannot join
- Mitral regurgitation or stenosis > I°
- Sp. mitral valve repair or replacement
- Pericardial effusion
- Atrial fibrillation/flutter
- Patients with pacemaker
- BMI > 35 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Left Ventricular Diastolic Function on Hemodynamic Stability During Anesthesia Induction and on Postoperative Complications
Diastolic dysfunction is an important cause of hemodynamic instability in the perioperative field.Therefore this study aims to investigate the influence of existing diastolic dysfunction or deterioration of diastolic function on hemodynamic stability during induction of anesthesia and postoperative complications. The impact of different anesthetics on diastolic function is investigated.
Read the detailed description
In this prospective observational study two cohorts of patients with different anesthesia regimes are investigated. Anesthesia is maintained with sevoflurane or propofol. Before induction of anesthesia a transthoracic echocardiography is performed to examine systolic and diastolic function. Immediately after induction, during maintenance and after completion of anesthesia any changes of diastolic function are examined with transthoracic echocardiography. All anesthetic medications, fluids, vasoactive medications and catecholamines are registered.
- Conditions
- Left Ventricular Diastolic Dysfunction
- Being tested
- Sevoflurane, Propofol
- Medical subject headings
- Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Anesthesia maintenance with Sevoflurane
PropofolDrug
Anesthesia maintenance with Propofol
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Anesthesia maintenance Receives: Drug: Sevoflurane | |
| Propofol | Anesthesia maintenance Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Norepinephrine
Cumulative dose of norepinephrine (adjusted for body weight) during the first 30 minutes after induction of anesthesia
Measured: 30 minutes after induction of anesthesia
Secondary outcomes (2)
e'
Change of the echocardiographic tissue doppler parameter e' after induction of anesthesia
Measured: Directly after induction of anesthesia
E / e'
Change of the echocardiographic index of transmitral flow and tissue doppler after induction of anesthesia
Measured: Directly after induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start1 Apr 2017
- Primary completion27 Sep 2018
- Study completion27 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Left Ventricular Diastolic DysfunctionStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katharina Roeher, Dr. med., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522194
- Sponsor's protocol ID
- PV 5436
- Status last verified
- Mar 2019
- First submitted
- 30 Apr 2018
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kahl U, Vens M, Pollok F, Menke M, Duckstein C, Gruetzmacher J, Schirren L, Yu Y, Fischer M, Zollner C, Goepfert MS, Roeher K. Do Elderly Patients With Diastolic Dysfunction Require Higher Doses of Norepinephrine During General Anesthesia for Noncardiac Surgeries? A Prospective Observational Study. Anesth Analg. 2021 Feb 1;132(2):420-429. doi: 10.1213/ANE.0000000000005304.
PubMed 33264119
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Left Ventricular Diastolic Function on Hemodynamic Stability During Anesthesia Induction and on Postoperative Complications
- ClinicalTrials.gov ID
- NCT03522194
- Acronym / sponsor ID
- PV 5436
- Conditions
- Left Ventricular Diastolic Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 27 Sep 2018 (actual)
- Study completion
- 27 Sep 2018 (actual)
- First posted
- 11 May 2018 (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.
Diastolic dysfunction is an important cause of hemodynamic instability in the perioperative field.Therefore this study aims to investigate the influence of existing diastolic dysfunction or deterioration of diastolic function on hemodynamic stability during induction of anesthesia and postoperative complications. The impact of different anesthetics on diastolic function is investigated.
Detailed description
In this prospective observational study two cohorts of patients with different anesthesia regimes are investigated. Anesthesia is maintained with sevoflurane or propofol. Before induction of anesthesia a transthoracic echocardiography is performed to examine systolic and diastolic function. Immediately after induction, during maintenance and after completion of anesthesia any changes of diastolic function are examined with transthoracic echocardiography. All anesthetic medications, fluids, vasoactive medications and catecholamines are registered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | – | Drug: SevofluraneAnesthesia maintenance |
| Propofol | – | Drug: PropofolAnesthesia maintenance |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients scheduled for surgery under general anesthesia
Key inclusion criteria (1 listed)
- Patients older than 60 years scheduled for general anesthesia
Key exclusion criteria (6 listed)
- Mitral regurgitation or stenosis > I°
- Sp. mitral valve repair or replacement
- Pericardial effusion
- Atrial fibrillation/flutter
- Patients with pacemaker
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 |
|---|---|---|
| SevofluraneAnesthesia maintenance with Sevoflurane | Drug | Sevoflurane |
| PropofolAnesthesia maintenance with Propofol | Drug | Propofol |
Primary outcome
Norepinephrine
Time frame: 30 minutes after induction of anesthesia
Cumulative dose of norepinephrine (adjusted for body weight) during the first 30 minutes after induction of anesthesia
2 secondary outcomes
e'
Time frame: Directly after induction of anesthesia
E / e'
Time frame: Directly after induction of anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Derived from this study: PubMed 33264119Kahl U, Vens M, Pollok F, Menke M, Duckstein C, Gruetzmacher J, Schirren L, Yu Y, Fischer M, Zollner C, Goepfert MS, Roeher K. Do Elderly Patients With Diastolic Dysfunction Require Higher Doses of Norepinephrine During General Anesthesia for Noncardiac Surgeries? A Prospective Observational Study. Anesth Analg. 2021 Feb 1;132(2):420-429. doi: 10.1213/ANE.0000000000005304.
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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.
Katharina Roeher, Dr. med. principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Diastolic Dysfunction, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 6 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: finished, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Norepinephrine (time frame: 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?
On the ClinicalTrials.gov record for NCT03522194, which also lists 1 linked publication.
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 12 Mar 2019.