Antihypertensives in Non-cardiac Surgical Population

Current Status of Antihypertensive Drug Treatment in Non-cardiac Surgical Population

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 351

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Renji Hospital, Shanghai Jiao Tong University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients undergoing elective non-cardiac surgery in Renji hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pH, base excess, and concentration of HCO3- in blood gases	arterial blood gases detected by using the ABL800 (Radiometer Med Aps Ltd, Copenhagen, Denmark)	5 minutes after extubating in PACU
the incidence of hypotension in PACU	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.	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 in PACU	the incidence of hypertension, which was defined as SBP greater than 120% of baseline	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.
hospitalization days	The duration of this single episode of hospitalization	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

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Study Chair: Jie Chen, M.S., Renji Hospital, School of Medicine, Shanghai Jiaotong University, China

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 23, 2018
• Primary Completion (ACTUAL): April 1, 2019
• Study Completion (ACTUAL): April 1, 2019

Study Registration Dates

• First Submitted: April 27, 2019
• First Submitted That Met QC Criteria: May 16, 2019
• First Posted (ACTUAL): May 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 17, 2019
• Last Update Submitted That Met QC Criteria: May 16, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: antihypertensives 2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No