ACE-Inhibitor Effects on Total Hip and Knee Arthroplasty Patients

Duke University59 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Adverse Effects of Angiotensin-converting-enzyme Inhibitors Hypotension

Interventions

ACE-I Cessation groupDRUG

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)

ACE-I Continuation groupDRUG

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Duke University

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Number of Participants With Mild Hypotension

The number of participants with mild hypotension (Systolic Blood Pressure (SBP) less than 85 mmHG) will be recorded.

Time frame: 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.

Time frame: From baseline to discharge from hospital (approximately 5 days)

Number of Participants Given Vasopressors

The number of participants who received vasopressors.

Time frame: Discharge from hospital (approximately 5 days)

Secondary Outcomes

Number of Participants Transferred to Intensive Care Unit (ICU)

The number of participants transferred to Intensive Care Unit (ICU) will be recorded

Time frame: Discharge from hospital (approximately 5 days)

Number of Participants That Received Allogeneic Blood

The number of participants that received allogeneic blood will be recorded.

Time frame: Discharge from hospital (approximately 5 days)

Number of Participants With Acute Kidney Injury

Number of participants with acute kidney injury will be recorded.

Time frame: Discharge from hospital (approximately 5 days)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.