Adverse Effects of Angiotensin-converting-enzyme Inhibitors, Hypotension
Conditions
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.
Interventions
DRUGACE-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)
DRUGACE-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)
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Randomization of participants occurred only if the proposed inclusion/exclusion criteria were met.
Participants by arm
| Arm | Count |
|---|---|
| Continuation Group ACE-I Continuation group: Subjects take ACE-I through day of surgery | 23 |
| Cessation Group ACE-I Cessation group: Subjects stop ACE-I 48 hours prior to surgery | 23 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | surgery not indicated in protocol | 1 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Cessation Group | Continuation Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 7 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 16 Participants | 29 Participants |
| Age, Continuous | 63.7 years STANDARD_DEVIATION 8.7 | 63.3 years STANDARD_DEVIATION 10.8 | 63.5 years STANDARD_DEVIATION 9.7 |
| Region of Enrollment United States | 23 Participants | 23 Participants | 46 Participants |
| Sex: Female, Male Female | 11 Participants | 8 Participants | 19 Participants |
| Sex: Female, Male Male | 12 Participants | 15 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 0 / 23 | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 |
Outcome results
Primary
Number of Participants Given Vasopressors
The number of participants who received vasopressors.
Time frame: Discharge from hospital (approximately 5 days)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Continuation Group | Number of Participants Given Vasopressors | Intraoperative | 19 Participants |
| Continuation Group | Number of Participants Given Vasopressors | Postoperative | 0 Participants |
| Cessation Group | Number of Participants Given Vasopressors | Intraoperative | 14 Participants |
| Cessation Group | Number of Participants Given Vasopressors | Postoperative | 0 Participants |
Comparison: Analysis for number of participants given vasopressors intraoperativelyp-value: 0.102t-test, 2 sided
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.
Time frame: From baseline to discharge from hospital (approximately 5 days)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Continuation Group | Number of Participants With Mild Hypotension | Intraoperative | 14 Participants |
| Continuation Group | Number of Participants With Mild Hypotension | Postoperative | 3 Participants |
| Cessation Group | Number of Participants With Mild Hypotension | Intraoperative | 9 Participants |
| Cessation Group | Number of Participants With Mild Hypotension | Postoperative | 2 Participants |
Comparison: Statistical analysis for intraoperative mild hypotensionp-value: 0.14t-test, 2 sided
Comparison: Statistical analysis for postoperative mild hypotensionp-value: 1t-test, 2 sided
Primary
Number of Participants With Severe Hypotension
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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Continuation Group | Number of Participants With Severe Hypotension | Intraoperative | 1 Participants |
| Continuation Group | Number of Participants With Severe Hypotension | Postoperative | 0 Participants |
| Cessation Group | Number of Participants With Severe Hypotension | Intraoperative | 0 Participants |
| Cessation Group | Number of Participants With Severe Hypotension | Postoperative | 0 Participants |
Secondary
Number of Participants That Received Allogeneic Blood
The number of participants that received allogeneic blood will be recorded.
Time frame: Discharge from hospital (approximately 5 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuation Group | Number of Participants That Received Allogeneic Blood | 1 Participants |
| Cessation Group | Number of Participants That Received Allogeneic Blood | 0 Participants |
Secondary
Number of Participants Transferred to Intensive Care Unit (ICU)
The number of participants transferred to Intensive Care Unit (ICU) will be recorded
Time frame: Discharge from hospital (approximately 5 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuation Group | Number of Participants Transferred to Intensive Care Unit (ICU) | 1 Participants |
| Cessation Group | Number of Participants Transferred to Intensive Care Unit (ICU) | 0 Participants |
Secondary
Number of Participants With Acute Kidney Injury
Number of participants with acute kidney injury will be recorded.
Time frame: Discharge from hospital (approximately 5 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuation Group | Number of Participants With Acute Kidney Injury | 5 Participants |
| Cessation Group | Number of Participants With Acute Kidney Injury | 3 Participants |
p-value: 0.7t-test, 2 sided
Post Hoc
Length of Stay
Length of stay in days
Time frame: Discharge from hospital (approximately 5 days)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Continuation Group | Length of Stay | 2.0 Days |
| Cessation Group | Length of Stay | 2.0 Days |
p-value: 0.702t-test, 2 sided