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Study of Preoperative Management of Angiotensin Converting Enzyme Inhibitor (ACEi) and Angiotensin Receptor Blocker (ARB) Medications (PASS)

L

Lawson Health Research Institute

Status

Completed

Conditions

Hypertension

Treatments

Procedure: Preoperative ACEi/ARB management

Study type

Interventional

Funder types

Other

Identifiers

NCT01091961
R-09-487
16503 (Other Identifier)

Details and patient eligibility

About

Patients on a stable dose of ACE inhibitor or ARB medication who are scheduled for elective surgery will be randomized to take their ACE inhibitor or ARB up to and including the morning of surgery, or to hold them a day prior to the surgery. The patients will be followed for 30 days after surgery to assess any adverse health outcomes.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • currently taking an ACEi, ARB or both
  • no change in these medications during the two weeks prior to study enrollment
  • scheduled for non-cardiac surgery requiring regional or general anesthesia
  • minimum overnight anticipated length of stay
  • age ≥18 years.

Exclusion criteria

  • explicit instructions provided to patient by surgical team regarding the perioperative management of ACEi or ARB
  • significant hypertension in pre-operative assessment clinic (systolic blood pressure ≥180 mmHg OR diastolic blood pressure ≥110 mmHg)
  • significant hypotension in pre-operative assessment clinic (systolic blood pressure < 90 mmHg)
  • prior enrollment in the study
  • participation in another research study of antihypertensive medications

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

200 participants in 2 patient groups

Continuing ACEi/ARB
Active Comparator group
Description:
Patients in this group will continue to take their chronic ACEi/ARB medications up to and including the day of surgery.
Treatment:
Procedure: Preoperative ACEi/ARB management
Holding ACEi/ARB
Active Comparator group
Description:
Patients in this arm will hold their chronic ACEi/ARB medication at least 24 hours prior to surgery.
Treatment:
Procedure: Preoperative ACEi/ARB management

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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