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ACE-Inhibitor Effects on Total Hip and Knee Arthroplasty Patients

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Duke University

Status

Terminated

Conditions

Hypotension
Adverse Effects of Angiotensin-converting-enzyme Inhibitors

Treatments

Drug: ACE-I Cessation group
Drug: ACE-I Continuation group

Study type

Interventional

Funder types

Other

Identifiers

NCT01867047
Pro00037620 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine the effects of Angiotension Converting Enzyme Inhibitors (ACE-I) during surgery and in the immediate postoperative period for patients undergoing elective total hip or knee arthroplasty.

Enrollment

59 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients electing to undergo primary or revision total hip or knee arthroplasty
  • Currently taking an ACE-I

Exclusion criteria

  • Trauma patients
  • Immunosuppressed patients (HIV/AIDS, organ transplant recipients, chemotherapy patients, chronic steroid use)
  • Patients with history of severe hypertension related illness such as hypertension associated with stroke or myocardial infarction
  • Patients in who continuation of their ACE-I is expressly mandated by their prescribing physician

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

59 participants in 2 patient groups

Continuation Group
Experimental group
Description:
Subjects randomized to this group will continue their ACE-I through the day of surgery
Treatment:
Drug: ACE-I Continuation group
Cessation Group
Experimental group
Description:
Subjects randomized to this group will stop their ACE-I two days prior to surgery (last dose \>48 hours prior to surgery)
Treatment:
Drug: ACE-I Cessation group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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