ACE-Inhibitor Effects on Total Hip and Knee Arthroplasty Patients

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.

Full Title of Study: “Effects of Angiotensin Converting Enzyme Inhibitors on Total Hip and Knee Arthroplasty Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 24, 2016

Interventions

  • Drug: 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)
  • 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)

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Duke University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michael Bolognesi, MD, Principal Investigator, Duke University

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