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ACE-Inhibitor Effects on Total Hip and Knee Arthroplasty Patients

NCT ID: NCT01867047

Last Updated: 2017-09-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-06-24

Brief Summary

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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.

Detailed Description

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Conditions

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Adverse Effects of Angiotensin-converting-enzyme Inhibitors Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Continuation Group

Subjects randomized to this group will continue their ACE-I through the day of surgery

Group Type EXPERIMENTAL

ACE-I Continuation group

Intervention Type DRUG

Subjects take ACE-I through day of surgery. Examples of possible ACE-I drugs include:

benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec, Epaned), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), trandolapril (Mavik)

Cessation Group

Subjects randomized to this group will stop their ACE-I two days prior to surgery (last dose \>48 hours prior to surgery)

Group Type EXPERIMENTAL

ACE-I Cessation group

Intervention Type DRUG

Subjects stop ACE-I 48 hours prior to surgery. Examples of possible ACE-I drugs include:

benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec, Epaned), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), trandolapril (Mavik)

Interventions

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ACE-I Cessation group

Subjects stop ACE-I 48 hours prior to surgery. Examples of possible ACE-I drugs include:

benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec, Epaned), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), trandolapril (Mavik)

Intervention Type DRUG

ACE-I Continuation group

Subjects take ACE-I through day of surgery. Examples of possible ACE-I drugs include:

benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec, Epaned), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), trandolapril (Mavik)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Bolognesi, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00037620

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00037620

Identifier Type: -

Identifier Source: org_study_id