ACE-Inhibitor Effects on Total Hip and Knee Arthroplasty Patients

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

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 Overview

• Status: Terminated
• Conditions: Hypotension; Adverse Effects of Angiotensin-converting-enzyme Inhibitors
• Intervention / Treatment: Drug: ACE-I Continuation group; Drug: ACE-I Cessation group

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuation Group; Subjects randomized to this group will continue their ACE-I through the day of surgery	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)
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)	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)

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Michael Bolognesi, MD, Duke University

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): June 24, 2016
• Study Completion (Actual): June 24, 2016

Study Registration Dates

• First Submitted: May 29, 2013
• First Submitted That Met QC Criteria: May 29, 2013
• First Posted (Estimate): June 3, 2013

Study Record Updates

• Last Update Posted (Actual): September 28, 2017
• Last Update Submitted That Met QC Criteria: August 30, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Angiotensin-Converting Enzyme Inhibitors
• Other Study ID Numbers: Pro00037620 (Other Identifier: Duke University IRB)