ACE-Inhibitor Effects on Total Hip and Knee Arthroplasty Patients

Not Applicable

Terminated

• Conditions: Adverse Effects of Angiotensin-converting-enzyme Inhibitors; Hypotension
• Interventions: Drug: ACE-I Cessation group; Drug: ACE-I Continuation group

• Registration Number: NCT01867047
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-29
• Study First Submitted QC: 2013-05-29
• Study Start: 2013-06
• Study First Posted: 2013-06-03
• Primary Completion: 2016-06-24
• Study Completion: 2016-06-24
• Status Verified: 2017-06
• Disposition First Submitted: 2017-06-23
• Disposition First Submitted QC: 2017-07-11
• Disposition First Posted: 2017-07-13
• Results First Submitted: 2017-08-30
• Results First Submitted QC: 2017-08-30
• Last Update Submitted: 2017-08-30
• Results First Posted: 2017-09-28
• Last Update Posted: 2017-09-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Patients electing to undergo primary or revision total hip or knee arthroplasty
• Currently taking an ACE-I

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Mild Hypotension	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	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	Discharge from hospital (approximately 5 days)	The number of participants who received vasopressors.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Transferred to Intensive Care Unit (ICU)	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	Discharge from hospital (approximately 5 days)	The number of participants that received allogeneic blood will be recorded.
Number of Participants With Acute Kidney Injury	Discharge from hospital (approximately 5 days)	Number of participants with acute kidney injury will be recorded.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States