ACE-Inhibitor Effects on Total Hip and Knee Arthroplasty Patients

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01867047
• Other study ID #: Pro00037620
• Secondary ID: Pro00037620
• Status: Terminated
• Phase: N/A
• First received: May 29, 2013
• Last updated: August 30, 2017
• Start date: June 2013
• Est. completion date: June 24, 2016

Study information

• Verified date: June 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: June 24, 2016
• Est. primary completion date: June 24, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adverse Effects of Angiotensin-converting-enzyme Inhibitors
• Hypotension

Intervention

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)
• 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)

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	Number of Participants Given Vasopressors	The number of participants who received vasopressors.	Discharge from hospital (approximately 5 days)
Secondary	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)
Secondary	Number of Participants That Received Allogeneic Blood	The number of participants that received allogeneic blood will be recorded.	Discharge from hospital (approximately 5 days)
Secondary	Number of Participants With Acute Kidney Injury	Number of participants with acute kidney injury will be recorded.	Discharge from hospital (approximately 5 days)