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| ID | Type | Description | Link |
|---|---|---|---|
| Pro00037620 | Other Identifier | Duke University IRB |
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Following an interim analysis the study team felt that there was enough data that showed no significant difference.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuation Group | Experimental | Subjects randomized to this group will continue their ACE-I through the day of surgery |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACE-I Cessation group | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| Number of Participants Given Vasopressors | The number of participants who received vasopressors. | Discharge from hospital (approximately 5 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Number of Participants That Received Allogeneic Blood |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Bolognesi, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27710 | United States |
Randomization of participants occurred only if the proposed inclusion/exclusion criteria were met.
Patients were prescreened by the study team and then identified and presented to the surgeon during the preoperative clinic visit. Once IRB approval was granted on 8-9-2012 study team started screening the clinic schedule for potential participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuation Group | ACE-I Continuation group: Subjects take ACE-I through day of surgery |
| FG001 | Cessation Group | ACE-I Cessation group: Subjects stop ACE-I 48 hours prior to surgery |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Continuation Group | ACE-I Continuation group: Subjects take ACE-I through day of surgery |
| BG001 | Cessation Group | ACE-I Cessation group: Subjects stop ACE-I 48 hours prior to surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | From baseline to discharge from hospital (approximately 5 days) |
|
Baseline to hospital discharge (approximately 5 days)
The study team only collected adverse events that were unanticipated and reported to the study coordinator.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Continuation Group | Subjects randomized to this group will continue their ACE-I through the day of surgery ACE-I Continuation group: Subjects take ACE-I through day of surgery |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Bolognesi, MD | Duke University Medical Center | michael.bolognesi@duke.edu |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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|
| ACE-I Continuation group | Drug | 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) |
|
The number of participants that received allogeneic blood will be recorded. |
| Discharge from hospital (approximately 5 days) |
| Number of Participants With Acute Kidney Injury | Number of participants with acute kidney injury will be recorded. | Discharge from hospital (approximately 5 days) |
| Physician Decision |
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| surgery not indicated in protocol |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Primary | Number of Participants With Severe Hypotension | The number of participants with severe hypotension (Systolic Blood Pressure less than 65 mmHG) will be recorded. | Posted | Count of Participants | Participants | From baseline to discharge from hospital (approximately 5 days) |
|
|
|
| Primary | Number of Participants Given Vasopressors | The number of participants who received vasopressors. | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | Discharge from hospital (approximately 5 days) |
|
|
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| Secondary | Number of Participants With Acute Kidney Injury | Number of participants with acute kidney injury will be recorded. | Posted | Count of Participants | Participants | Discharge from hospital (approximately 5 days) |
|
|
|
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| Post-Hoc | Length of Stay | Length of stay in days | Posted | Median | Full Range | Days | Discharge from hospital (approximately 5 days) |
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|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Cessation Group | Subjects randomized to this group will stop their ACE-I two days prior to surgery (last dose >48 hours prior to surgery) ACE-I Cessation group: Subjects stop ACE-I 48 hours prior to surgery | 0 | 23 | 0 | 23 | 0 | 23 |
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