ACE-Inhibitor Effects on Total Hip and Knee Arthroplasty Patients

Study Overview
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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.

Official Title
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Effects of Angiotensin Converting Enzyme Inhibitors on Total Hip and Knee Arthroplasty Patients

Conditions
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Adverse Effects of Angiotensin-converting-enzyme Inhibitors, Hypotension

Intervention / Treatment
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* Drug: ACE-I Cessation group
* Drug: ACE-I Continuation group


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuation Group<br>Subjects randomized to this group will continue their ACE-I through the day of surgery | Drug: ACE-I Continuation group<br>* 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)<br>|
| Experimental: Cessation Group<br>Subjects randomized to this group will stop their ACE-I two days prior to surgery (last dose >48 hours prior to surgery) | Drug: ACE-I Cessation group<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Mild Hypotension | The number of participants with mild hypotension (Systolic Blood Pressure (SBP) less than 85 mmHG) will be recorded. | From baseline to discharge from hospital (approximately 5 days) | 
| Number of Participants With Severe Hypotension | The number of participants with severe hypotension (Systolic Blood Pressure less than 65 mmHG) will be recorded. | From baseline to discharge from hospital (approximately 5 days) | 
| Number of Participants Given Vasopressors | The number of participants who received vasopressors. | Discharge from hospital (approximately 5 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Transferred to Intensive Care Unit (ICU) | The number of participants transferred to Intensive Care Unit (ICU) will be recorded | Discharge from hospital (approximately 5 days) | 
| Number of Participants That Received Allogeneic Blood | The number of participants that received allogeneic blood will be recorded. | Discharge from hospital (approximately 5 days) | 
| Number of Participants With Acute Kidney Injury | Number of participants with acute kidney injury will be recorded. | Discharge from hospital (approximately 5 days) |