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Antihypertensives in Non-cardiac Surgical Population

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ClinicalTrials.gov Identifier: NCT03953872
Recruitment Status : Completed
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

Brief Summary:
A cohort of hypertension patients undergoing elective non-cardiac surgery was constructed to investigate current status of antihypertensive drug treatment in non-cardiac surgical population.

Condition or disease
Perioperative Antihypertensive

Detailed Description:
Perioperative changes in blood pressure (BP) are associated with perioperative risks. However, there is little information regarding the current status of antihypertensive treatment in non-cardiac surgical population. A cohort of 351 hypertension patients aged between 18 to 85-year old undergoing elective non-cardiac surgery was constructed to investigate the application of antihypertensive drugs, systemic involvement, perioperative hemodynamics and internal environment to grasp the perioperative impact of different antihypertensive drugs, and to further provide a reference for the preoperative antihypertensive strategy of surgery patients.

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Study Type : Observational
Actual Enrollment : 351 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Current Status of Antihypertensive Drug Treatment in Non-cardiac Surgical Population
Actual Study Start Date : November 23, 2018
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
ARB
Group of angiotensin receptor blockers(ARB) monotherapy users. A subject was considered as an ARB user when the total prescription days of ARB monotherapy was at least 30.
combination of CCB and ARB
Group of calcium channel blockers(CCB) and angiotensin receptor blockers(ARB) combination users. A subject was considered as a CCB and ARB combination user when the total prescription days of CCB and ARB combination therapy was at least 30.
CCB
Group of calcium channel blockers(CCB) monotherapy users. A subject was considered as a CCB user when the total prescription days of CCB monotherapy was at least 30.
No treatment
Group of nonusers of antihypertensives. A subject was considered as a nonuser never received regular antihypertensive treatment or total prescription days of antihypertensives was less than 30.



Primary Outcome Measures :
  1. perioperative blood press(BP) [ Time Frame: from the moment on arrival to the operating room until the moment leaving PACU, assessed up to 240 minutes. ]
    baseline BP before the operation, when entering and exiting post-anesthesia care unit(PACU)


Secondary Outcome Measures :
  1. pH, base excess, and concentration of HCO3- in blood gases [ Time Frame: 5 minutes after extubating in PACU ]
    arterial blood gases detected by using the ABL800 (Radiometer Med Aps Ltd, Copenhagen, Denmark)

  2. the incidence of hypotension in PACU [ Time Frame: from the moment on arrival to PACU until 60 minutes after arriving or the moment leaving PACU, whichever came first, assessed up to 240 minutes. ]
    If there were more than two consecutive episodes of hypotension (which was defined as SBP less than 80% of baseline) a "rescue" intravenous bolus of 100 mg of phenylephrine was given.

  3. the incidence of hypertension in PACU [ Time Frame: from the moment on arrival to PACU until 60 minutes after arriving or the moment leaving PACU, whichever came first, assessed up to 240 minutes. ]
    the incidence of hypertension, which was defined as SBP greater than 120% of baseline

  4. hospitalization days [ Time Frame: from the date of admission until the date of discharge or date of death from any cause, whichever came first, assessed up to 100 days ]
    The duration of this single episode of hospitalization



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients undergoing elective non-cardiac surgery in Renji hospital
Criteria

Inclusion Criteria:

  • patients undergoing elective non-cardiac surgery with hypertension(i.e., with a systolic blood pressure(SBP) of >=140 mmHg and/or a diastolic blood pressure(DBP) of >=90 mmHg based on the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure) or self-reported use of antihypertensive medication

Exclusion Criteria:

  • Patients under the age of 18 years old
  • Patients more than 85 years old
  • Patients suspected of intracranial hypertension

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953872


Locations
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China, Shanghai
Renji Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai, China, 200127
Sponsors and Collaborators
RenJi Hospital
Investigators
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Study Chair: Jie Chen, M.S. Renji Hospital, School of Medicine, Shanghai Jiaotong University, China

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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT03953872     History of Changes
Other Study ID Numbers: antihypertensives 2019
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Antihypertensive Agents
Calcium Channel Blockers
Angiotensin Receptor Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs