Back to resultsACE-Inhibitor Effects on Total Hip and Knee Arthroplasty Patients
Primary Purpose
Adverse Effects of Angiotensin-converting-enzyme Inhibitors, Hypotension
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACE-I Cessation group
ACE-I Continuation group
Sponsored by
About this trial
This is an interventional supportive care trial for Adverse Effects of Angiotensin-converting-enzyme Inhibitors
Eligibility 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
Sites / Locations
- Duke University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Continuation Group
Cessation Group
Arm Description
Subjects randomized to this group will continue their ACE-I through the day of surgery
Subjects randomized to this group will stop their ACE-I two days prior to surgery (last dose >48 hours prior to surgery)
Outcomes
Primary Outcome Measures
Number of Participants With Mild Hypotension
The number of participants with mild hypotension (Systolic Blood Pressure (SBP) less than 85 mmHG) will be recorded.
Number of Participants With Severe Hypotension
The number of participants with severe hypotension (Systolic Blood Pressure less than 65 mmHG) will be recorded.
Number of Participants Given Vasopressors
The number of participants who received vasopressors.
Secondary Outcome Measures
Number of Participants Transferred to Intensive Care Unit (ICU)
The number of participants transferred to Intensive Care Unit (ICU) will be recorded
Number of Participants That Received Allogeneic Blood
The number of participants that received allogeneic blood will be recorded.
Number of Participants With Acute Kidney Injury
Number of participants with acute kidney injury will be recorded.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01867047
Brief Title
ACE-Inhibitor Effects on Total Hip and Knee Arthroplasty Patients
Official Title
Effects of Angiotensin Converting Enzyme Inhibitors on Total Hip and Knee Arthroplasty Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
Following an interim analysis the study team felt that there was enough data that showed no significant difference.
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 24, 2016 (Actual)
Study Completion Date
June 24, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Effects of Angiotensin-converting-enzyme Inhibitors, Hypotension
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continuation Group
Arm Type
Experimental
Arm Description
Subjects randomized to this group will continue their ACE-I through the day of surgery
Arm Title
Cessation Group
Arm Type
Experimental
Arm Description
Subjects randomized to this group will stop their ACE-I two days prior to surgery (last dose >48 hours prior to surgery)
Intervention Type
Drug
Intervention Name(s)
ACE-I Cessation group
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
ACE-I Continuation group
Intervention Description
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)
Primary Outcome Measure Information:
Title
Number of Participants With Mild Hypotension
Description
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)
Title
Number of Participants With Severe Hypotension
Description
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)
Title
Number of Participants Given Vasopressors
Description
The number of participants who received vasopressors.
Time Frame
Discharge from hospital (approximately 5 days)
Secondary Outcome Measure Information:
Title
Number of Participants Transferred to Intensive Care Unit (ICU)
Description
The number of participants transferred to Intensive Care Unit (ICU) will be recorded
Time Frame
Discharge from hospital (approximately 5 days)
Title
Number of Participants That Received Allogeneic Blood
Description
The number of participants that received allogeneic blood will be recorded.
Time Frame
Discharge from hospital (approximately 5 days)
Title
Number of Participants With Acute Kidney Injury
Description
Number of participants with acute kidney injury will be recorded.
Time Frame
Discharge from hospital (approximately 5 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Bolognesi, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Learn more about this trial
ACE-Inhibitor Effects on Total Hip and Knee Arthroplasty Patients
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