HypertensionNCT02435875
Perioperative Baroreflex Sensitivity
An observational study of Hypertension and Hemodynamic Instability, run by RenJi Hospital at 1 site in China.
Trial summary
Impaired baroreflex sensitivity (BRS) is a marker of autonomous dysfunction, which may play an important role in the long-term development of hypertension. Perioperative patients with hypertension is rapidly growing in all populations worldwide. However, no study has reported the values of BRS in this cohort. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Hemodynamic Instability, Surgery
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Apr 2016
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients undergoing ordinary thoracic surgery
Who may be able to join
- Patients undergoing ordinary thoracic surgery and age between 18 and 70;
- American society of anesthesiologists(ASA) classification I to II level;
- Willing to participate in this study and signed an informed consent
Who cannot join
- 1.Patients with diabetes mellitus, cardiopulmonary dysfunction, severe liver and kidney dysfunction and disease of nervous system;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai Municipality, 200127
DAN HUANG, MS, 15921108822, huangdan363@163.com
JIE CHEN, MS, 13611906592, 13611906592@163.com
About this study
Official title: The Analysis of Perioperative Baroreflex Sensitivity in Hypertensives
Impaired baroreflex sensitivity (BRS) is a marker of autonomous dysfunction, which may play an important role in the long-term development of hypertension. Perioperative patients with hypertension is rapidly growing in all populations worldwide. However, no study has reported the values of BRS in this cohort. The aim of this study was to estimate the value of BRS for hypertension in a surgery cohort.
Read the detailed description
Hypertension is known to be a major risk factor of end-organ damage, stroke and coronary mortality.It is estimated that one in six people worldwide, or nearly one billion, are affected by high blood pressure, and it is estimated that this number will increase to 1.5 billion by 2025. The World Health Organization also stated that high blood pressure is the most attributable cause of cardiovascular death.As the speed of aging is accelerated, the amount of perioperative hypertensive patients continue to increase. Perioperative hypertension had been shown to be a risk factor for the development of perioperative morbidity and mortality.Although it has aroused people's attention, there still lack of system evaluation and effective control. Therefore, it's urgent and necessary to assess and intervene perioperative situation of hypertensive patients.
The pathogenesis of hypertension is very complex, while the exact mechanism is still unclear. The dysfunction of autonomic activity, marked in particular by sympathetic overactivity and reduced parasympathetic activity, has been hypothesized to underlie the development of hypertension.Baroreflex control is one of the key mechanisms responsible for the short-term control of blood pressure.It acts as a closed loop, negative feedback mechanism, aimed at stabilizing blood pressure around a set point value.The impairment of baroreflex sensitivity (BRS) is know as the predictive factor of mortality in hypertension. A large of clinical and basic research indicated the existence of autonomic dysfunction and impaired BRS in patients with essential hypertension.
However, no study has reported the values of perioperative BRS, especially in hypertensive patients . Therefore, the aim of this study was to estimate the value of BRS for hypertension in a surgery cohort, and to explore the functional status of autonomic nervous system, may provide reference for clinical treatment.
- Conditions
- Hypertension, Hemodynamic Instability, Surgery
- Being tested
- no intervention
- Keywords
- hypertension, perioperative, baroreflex sensitivity
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
Antihypertensive drug as intervention is used to see if it can improve baroreflex sensitivity to stable perioperative hemodynamic
| Study group | Role | What they receive |
|---|---|---|
| hypertensive | Patients with confirmed hypertension or systolic blood pressure≥140 mmHg or diastolic blood pressure≥90 mmHg without antihypertensive treatment.After anesthesia induction,baroreflex sensitivity will be measured by nitroglycerin. Receives: Other: no intervention | |
| nonhypertensive | systolic blood pressure <140 mmHg and diastolic blood pressure<90 mmHg.After anesthesia induction,baroreflex sensitivity will be measured by nitroglycerin. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
baroreflex sensitivity
Baroreflex sensitivity will be measured at three points include preoperation,intraoperation and postoperation
Measured: during operation
Secondary outcomes (4)
interoperation complication
Assessment of the incident of severe arrhythmia and blood pressure fluctuations
Measured: during operation
length of hospital stay
This assess how long patients stay in hospital
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 days
post-operative complications
Assessment of the incident of myocardial infarction,cerebral infarction and renal failure
Measured: 3 days postoperation
hospitalization costs
Hospitalization costs will be assessed after patients discharged from hospital
Measured: 2 weeks postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
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
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DAN HUANG, RenJi Hospital
- Investigators
- WEIFENG YU, MD, Study chair, Anesthesiology Department Renji Hospital, Shanghai Jiao Tong University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435875
- Sponsor's protocol ID
- Renji1501
- Status last verified
- Apr 2015
- First submitted
- 15 Apr 2015
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analysis of Perioperative Baroreflex Sensitivity in Hypertensives
- ClinicalTrials.gov ID
- NCT02435875
- Acronym / sponsor ID
- Renji1501
- Conditions
- Hypertension, Hemodynamic Instability, Surgery
- Keywords
- hypertension, perioperative, baroreflex sensitivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 6 May 2015 (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.
Impaired baroreflex sensitivity (BRS) is a marker of autonomous dysfunction, which may play an important role in the long-term development of hypertension. Perioperative patients with hypertension is rapidly growing in all populations worldwide. However, no study has reported the values of BRS in this cohort. The aim of this study was to estimate the value of BRS for hypertension in a surgery cohort.
Detailed description
Hypertension is known to be a major risk factor of end-organ damage, stroke and coronary mortality.It is estimated that one in six people worldwide, or nearly one billion, are affected by high blood pressure, and it is estimated that this number will increase to 1.5 billion by 2025. The World Health Organization also stated that high blood pressure is the most attributable cause of cardiovascular death.As the speed of aging is accelerated, the amount of perioperative hypertensive patients continue to increase. Perioperative hypertension had been shown to be a risk factor for the development of perioperative morbidity and mortality.Although it has aroused people's attention, there still lack of system evaluation and effective control. Therefore, it's urgent and necessary to assess and intervene perioperative situation of hypertensive patients.
The pathogenesis of hypertension is very complex, while the exact mechanism is still unclear. The dysfunction of autonomic activity, marked in particular by sympathetic overactivity and reduced parasympathetic activity, has been hypothesized to underlie the development of hypertension.Baroreflex control is one of the key mechanisms responsible for the short-term control of blood pressure.It acts as a closed loop, negative feedback mechanism, aimed at stabilizing blood pressure around a set point value.The impairment of baroreflex sensitivity (BRS) is know as the predictive factor of mortality in hypertension. A large of clinical and basic research indicated the existence of autonomic dysfunction and impaired BRS in patients with essential hypertension.
However, no study has reported the values of perioperative BRS, especially in hypertensive patients . Therefore, the aim of this study was to estimate the value of BRS for hypertension in a surgery cohort, and to explore the functional status of autonomic nervous system, may provide reference for clinical treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypertensive | – | Other: no interventionPatients with confirmed hypertension or systolic blood pressure≥140 mmHg or diastolic blood pressure≥90 mmHg without antihypertensive treatment.After anesthesia induction,baroreflex sensitivity will be measured by nitroglycerin. |
| nonhypertensive | – | Other: no interventionsystolic blood pressure <140 mmHg and diastolic blood pressure<90 mmHg.After anesthesia induction,baroreflex sensitivity will be measured by nitroglycerin. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing ordinary thoracic surgery
Key inclusion criteria (3 listed)
- Patients undergoing ordinary thoracic surgery and age between 18 and 70;
- American society of anesthesiologists(ASA) classification I to II level;
- Willing to participate in this study and signed an informed consent
Key exclusion criteria (1 listed)
- 1.Patients with diabetes mellitus, cardiopulmonary dysfunction, severe liver and kidney dysfunction and disease of nervous system;
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 |
|---|---|---|
| no interventionAntihypertensive drug as intervention is used to see if it can improve baroreflex sensitivity to stable perioperative hemodynamic | Other | hypertensive, nonhypertensive |
Primary outcome
baroreflex sensitivity
Time frame: during operation
Baroreflex sensitivity will be measured at three points include preoperation,intraoperation and postoperation
4 secondary outcomes
interoperation complication
Time frame: during operation
length of hospital stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
post-operative complications
Time frame: 3 days postoperation
hospitalization costs
Time frame: 2 weeks postoperation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
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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.
WEIFENG YU, MD study chair
Anesthesiology Department Renji Hospital, Shanghai Jiao Tong University, School of Medicine
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 Hemodynamic Instability, run by RenJi Hospital at 1 site in China.
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 1 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 6 May 2015. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DAN HUANG, MS (15921108822, huangdan363@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
baroreflex sensitivity (time frame: during operation). 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 6 May 2015.