HypertensionNCT00700466
Intravenous Beta-blockade for Improvement of Autonomic Activity
An observational study of Hypertension and Tachycardia, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
Chronic beta-adrenoceptor blockade is known to improve outcome of high risk patients whereas amelioration of autonomic activity was demonstrated to be a major cause of outcome improvement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Tachycardia, Heart Rate Variability
- What is being tested?
- i.v. beta-blocker infusion (metoprolol)
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2008to Nov 2009
- 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 scheduled for coronary artery bypass surgery
Who may be able to join
- Patients scheduled for coronary artery bypass surgery
- Ejection fraction > 30 %
- Informed consent
Who cannot join
- Emergency cases
- Myocardiac infraction within 4 weeks
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Schleswig-Holstein, Campus Kiel, Germany
Kiel, Schleswig-Holstein, 24105
About this study
Official title: Beta-adrenoceptor Blockade Prior to Induction of Anesthesia for Improvement of Depressed Autonomic Regulation
Chronic beta-adrenoceptor blockade is known to improve outcome of high risk patients whereas amelioration of autonomic activity was demonstrated to be a major cause of outcome improvement. Therefore, perioperative beta-adrenoceptor blockade is recommended in patients with Revised Cardiac Risk Index score of three or greater. The investigators hypothesise that preoperative intravenous beta-adrenoceptor blockade for treatment of hypertension and/or tachycardia improves autonomic activity reflected by increase of Total Power of Heart Rate Variability.
Material and Methods: After IRB approval 20 patients scheduled for elective cardiac surgery were included into the study. Routine medication was continued throughout the study as recommended by the guidelines. HRV (TP and Low to High Frequency ratio (LF/HF) reflecting sympathetic to parasympathetic balance) was analysed prior to induction of general anesthesia and beta-adrenoceptor blockade in all patients (Baseline). Patients were assigned by their baseline hemodynamics. Patients with hypertension (systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg) or tachycardia (heart rate > 80bpm) were assigned to group BETA-BLOCK. In this group metoprolol-boli (2mg) were administered intravenously in stepwise manner until hemodynamic values decreased to normal. Total dosage was recorded. After normalisation of hemodynamics, second HRV analysis was performed (Intervention). Normotensive and normocardic patients were assigned to group CONTROL. No intervention was performed. Statistics: Mann Whitney U test for comparison between groups and between events Baseline and Intervention within group BETA-BLOCK, p<0.05.
- Conditions
- Hypertension, Tachycardia, Heart Rate Variability
- Being tested
- i.v. beta-blocker infusion (metoprolol)
- Keywords
- Outcome assessment, patients;, autonomic nervous system;, perioperative care;, adrenergic beta antagonist, Autonomic regulation, Perioperative beta-blockade, outcome
- Medical subject headings
- Hypertension, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i.v. beta-blocker infusion (metoprolol)Drug
Also called Metorpolol, Lopresor(R)
A beta-blocker (metoprolol) will be infused for treatment of hypertension and/or tachycardia prior to induction of anesthesia aiming at decrease of blood pressure and heart rate to normal limits
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with hypertension and/or tachycardia prior to induction of anesthesia requiring i.v. beta-blockade for treatment of raised hemodynamic Receives: Drug: i.v. beta-blocker infusion (metoprolol) | |
| 2 | Patients with normal hemodynamic values prior to induction of anesthesia not requiring treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of heart rate variability reflecting autonomic activity in the course of i.v. beta-blockade
Measured: Baseline, after i.v. beta-blockade, 6 months after discharge
Secondary outcomes (1)
Hospital stay, one-year cardiac mortality and morbidity after discharge
Measured: Postoperatively until discharge, between discharge and 1 year after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Investigators
- Robert Hanss, MD, Principal investigator, Consultant in Anesthesiology, Dep. of Anesthesiology and Intenisve Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700466
- Sponsor's protocol ID
- Hanss_EA 162/07
- Status last verified
- Feb 2009
- First submitted
- 13 Jun 2008
- Last updated
- 18 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-adrenoceptor Blockade Prior to Induction of Anesthesia for Improvement of Depressed Autonomic Regulation
- ClinicalTrials.gov ID
- NCT00700466
- Acronym / sponsor ID
- Hanss_EA 162/07
- Conditions
- Hypertension, Tachycardia, Heart Rate Variability
- Keywords
- Outcome assessment, patients;, autonomic nervous system;, perioperative care;, adrenergic beta antagonist, Autonomic regulation, Perioperative beta-blockade, outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 18 Jun 2008 (estimated)
- 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.
Chronic beta-adrenoceptor blockade is known to improve outcome of high risk patients whereas amelioration of autonomic activity was demonstrated to be a major cause of outcome improvement. Therefore, perioperative beta-adrenoceptor blockade is recommended in patients with Revised Cardiac Risk Index score of three or greater. The investigators hypothesise that preoperative intravenous beta-adrenoceptor blockade for treatment of hypertension and/or tachycardia improves autonomic activity reflected by increase of Total Power of Heart Rate Variability.
Material and Methods: After IRB approval 20 patients scheduled for elective cardiac surgery were included into the study. Routine medication was continued throughout the study as recommended by the guidelines. HRV (TP and Low to High Frequency ratio (LF/HF) reflecting sympathetic to parasympathetic balance) was analysed prior to induction of general anesthesia and beta-adrenoceptor blockade in all patients (Baseline). Patients were assigned by their baseline hemodynamics. Patients with hypertension (systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg) or tachycardia (heart rate > 80bpm) were assigned to group BETA-BLOCK. In this group metoprolol-boli (2mg) were administered intravenously in stepwise manner until hemodynamic values decreased to normal. Total dosage was recorded. After normalisation of hemodynamics, second HRV analysis was performed (Intervention). Normotensive and normocardic patients were assigned to group CONTROL. No intervention was performed. Statistics: Mann Whitney U test for comparison between groups and between events Baseline and Intervention within group BETA-BLOCK, p<0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: i.v. beta-blocker infusion (metoprolol)Patients with hypertension and/or tachycardia prior to induction of anesthesia requiring i.v. beta-blockade for treatment of raised hemodynamic |
| 2 | – | –Patients with normal hemodynamic values prior to induction of anesthesia not requiring treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for coronary artery bypass surgery
Key inclusion criteria (3 listed)
- Patients scheduled for coronary artery bypass surgery
- Ejection fraction > 30 %
- Informed consent
Key exclusion criteria (2 listed)
- Emergency cases
- Myocardiac infraction within 4 weeks
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 |
|---|---|---|
| i.v. beta-blocker infusion (metoprolol)Also: Metorpolol, Lopresor(R)A beta-blocker (metoprolol) will be infused for treatment of hypertension and/or tachycardia prior to induction of anesthesia aiming at decrease of blood pressure and heart rate to normal limits | Drug | 1 |
Primary outcome
Improvement of heart rate variability reflecting autonomic activity in the course of i.v. beta-blockade
Time frame: Baseline, after i.v. beta-blockade, 6 months after discharge
1 secondary outcome
Hospital stay, one-year cardiac mortality and morbidity after discharge
Time frame: Postoperatively until discharge, between discharge and 1 year after discharge
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 18 Jan 2010.
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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.
Robert Hanss, MD principal investigator
Consultant in Anesthesiology, Dep. of Anesthesiology and Intenisve Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel, Germany
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 Hypertension and Tachycardia, run by University Hospital Schleswig-Holstein 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 3 inclusion and 2 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 18 Jan 2010. 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?
Improvement of heart rate variability reflecting autonomic activity in the course of i.v. beta-blockade (time frame: Baseline, after i.v. beta-blockade, 6 months after discharge). 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 18 Jan 2010.