ACE-Inhibitor Effects on Total Hip and Knee Arthroplasty Patients

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)

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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