Adverse Effects of Angiotensin-converting-enzyme InhibitorsNCT01867047

ACE-Inhibitor Effects on Total Hip and Knee Arthroplasty Patients

A study testing ACE-I Cessation group and ACE-I Continuation group in people with Adverse Effects of Angiotensin-converting-enzyme Inhibitors and Hypotension, run by Duke University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Adverse Effects of Angiotensin-converting-enzyme Inhibitors, Hypotension
What is being tested?: ACE-I Cessation group and ACE-I Continuation group
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 59 participants
Where: 1 siteUnited States
Study dates: Jun 2013to 24 Jun 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University
Durham, North Carolina, 27710

Other trials in United States

About this study

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

Conditions: Adverse Effects of Angiotensin-converting-enzyme Inhibitors, Hypotension
Being tested: ACE-I Cessation group, ACE-I Continuation group
Medical subject headings: Hypotension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ACE-I Cessation groupDrug
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 groupDrug
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)

Study groups in NCT01867047
Study group	Role	What they receive
Continuation Group	Experimental	Subjects randomized to this group will continue their ACE-I through the day of surgery Receives: Drug: ACE-I Continuation group
Cessation Group	Experimental	Subjects randomized to this group will stop their ACE-I two days prior to surgery (last dose >48 hours prior to surgery) Receives: Drug: ACE-I Cessation group

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Mild Hypotension
The number of participants with mild hypotension (Systolic Blood Pressure (SBP) less than 85 mmHG) will be recorded.
Measured: 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.
Measured: From baseline to discharge from hospital (approximately 5 days)
Number of Participants Given Vasopressors
The number of participants who received vasopressors.
Measured: Discharge from hospital (approximately 5 days)

Secondary outcomes (3)

Number of Participants Transferred to Intensive Care Unit (ICU)
The number of participants transferred to Intensive Care Unit (ICU) will be recorded
Measured: Discharge from hospital (approximately 5 days)
Number of Participants That Received Allogeneic Blood
The number of participants that received allogeneic blood will be recorded.
Measured: Discharge from hospital (approximately 5 days)
Number of Participants With Acute Kidney Injury
Number of participants with acute kidney injury will be recorded.
Measured: Discharge from hospital (approximately 5 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 201324 Jun 2016

First posted3 Jun 2013 (estimated)
Study startJun 2013
Primary completion24 Jun 2016
Study completion24 Jun 2016

Why it stopped: Following an interim analysis the study team felt that there was enough data that showed no significant difference.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Adverse Effects of Angiotensin-converting-enzyme InhibitorsStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01867047
Sponsor's protocol ID: Pro00037620
Other IDs: Pro00037620
Status last verified: Jun 2017
First submitted: 29 May 2013
Last updated: 28 Sep 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Angiotensin Converting Enzyme Inhibitors on Total Hip and Knee Arthroplasty Patients
ClinicalTrials.gov ID: NCT01867047
Acronym / sponsor ID: Pro00037620
Conditions: Adverse Effects of Angiotensin-converting-enzyme Inhibitors, Hypotension
Study type: Interventional
Recruitment status: TerminatedReason stopped: Following an interim analysis the study team felt that there was enough data that showed no significant difference.
Enrolment: 59 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Study start: Jun 2013
Primary completion: 24 Jun 2016 (actual)
Study completion: 24 Jun 2016 (actual)
First posted: 3 Jun 2013 (estimated)
Results: Posted 28 Sep 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Continuation Group	Experimental	Drug: ACE-I Continuation groupSubjects randomized to this group will continue their ACE-I through the day of surgery
Cessation Group	Experimental	Drug: ACE-I Cessation groupSubjects randomized to this group will stop their ACE-I two days prior to surgery (last dose >48 hours prior to surgery)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ACE-I Cessation groupSubjects 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)	Drug	Cessation Group
ACE-I Continuation groupSubjects 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)	Drug	Continuation Group

Primary outcome

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

3 secondary outcomes

Number of Participants Transferred to Intensive Care Unit (ICU)
Time frame: Discharge from hospital (approximately 5 days)
Number of Participants That Received Allogeneic Blood
Time frame: Discharge from hospital (approximately 5 days)
Number of Participants With Acute Kidney Injury
Time frame: Discharge from hospital (approximately 5 days)

Results and safety

Results posted to the registry on 28 Sep 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Continuation Group	31	23
Cessation Group	28	23

Primary outcome: Number of Participants With Mild Hypotension

Time frame: From baseline to discharge from hospital (approximately 5 days). Count of participants. Unit: Participants

Measure	Continuation Group n = 23	Cessation Group n = 23
Intraoperative	14	9
Postoperative	3	2

Continuation Group vs Cessation Group: p = 0.140, t-test, 2 sided
Continuation Group vs Cessation Group: p = 1.000, t-test, 2 sided

Primary outcome: Number of Participants With Severe Hypotension

Time frame: From baseline to discharge from hospital (approximately 5 days). Count of participants. Unit: Participants

Measure	Continuation Group n = 23	Cessation Group n = 23
Intraoperative	1	0
Postoperative	0	0

Primary outcome: Number of Participants Given Vasopressors

Time frame: Discharge from hospital (approximately 5 days). Count of participants. Unit: Participants

Measure	Continuation Group n = 23	Cessation Group n = 23
Intraoperative	19	14
Postoperative	0	0

Continuation Group vs Cessation Group: p = 0.102, t-test, 2 sided

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to hospital discharge (approximately 5 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Continuation Group	0 of 23 (0%)	0 of 23 (0%)	0 of 23
Cessation Group	0 of 23 (0%)	0 of 23 (0%)	0 of 23

Limitations and caveats (from the sponsor): Limitations of this study include a low power, as the investigators assessed a relatively small number of participants, and as such the investigators recommend repeated studies with larger numbers of participants.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Bolognesi, MD principal investigator

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Mild Hypotension (time frame: From baseline to discharge from hospital (approximately 5 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01867047.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2017.