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ACE-Inhibitor Effects on Total Hip and Knee Arthroplasty Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01867047
Recruitment Status : Terminated (Following an interim analysis the study team felt that there was enough data that showed no significant difference.)
First Posted : June 3, 2013
Results First Posted : September 28, 2017
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Adverse Effects of Angiotensin-converting-enzyme Inhibitors Hypotension Drug: ACE-I Cessation group Drug: ACE-I Continuation group Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Angiotensin Converting Enzyme Inhibitors on Total Hip and Knee Arthroplasty Patients
Study Start Date : June 2013
Actual Primary Completion Date : June 24, 2016
Actual Study Completion Date : June 24, 2016

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Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Number of Participants Given Vasopressors [ Time Frame: Discharge from hospital (approximately 5 days) ]
    The number of participants who received vasopressors.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01867047


Locations
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United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Michael Bolognesi, MD Duke University
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01867047    
Other Study ID Numbers: Pro00037620
Pro00037620 ( Other Identifier: Duke University IRB )
First Posted: June 3, 2013    Key Record Dates
Results First Posted: September 28, 2017
Last Update Posted: September 28, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Angiotensin-Converting Enzyme Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action