NCT02435875

Brief 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. The aim of this study was to estimate the value of BRS for hypertension in a surgery cohort.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 6, 2015

Status Verified

April 1, 2015

Enrollment Period

1 year

First QC Date

April 15, 2015

Last Update Submit

April 30, 2015

Conditions

Keywords

hypertensionperioperativebaroreflex sensitivity

Outcome Measures

Primary Outcomes (1)

  • baroreflex sensitivity

    Baroreflex sensitivity will be measured at three points include preoperation,intraoperation and postoperation

    during operation

Secondary Outcomes (4)

  • interoperation complication

    during operation

  • length of hospital stay

    participants will be followed for the duration of hospital stay, an expected average of 5 days

  • post-operative complications

    3 days postoperation

  • hospitalization costs

    2 weeks postoperation

Study Arms (2)

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.

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.

Other: no intervention

Interventions

Antihypertensive drug as intervention is used to see if it can improve baroreflex sensitivity to stable perioperative hemodynamic

hypertensivenonhypertensive

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients undergoing ordinary thoracic surgery

You may qualify if:

  • 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

You may not qualify if:

  • Patients with diabetes mellitus, cardiopulmonary dysfunction, severe liver and kidney dysfunction and disease of nervous system;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital, Shanghai Jiao Tong University, School of Medicine

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • WEIFENG YU, MD

    Anesthesiology Department Renji Hospital, Shanghai Jiao Tong University, School of Medicine

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 15, 2015

First Posted

May 6, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 6, 2015

Record last verified: 2015-04

Locations