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The purpose of this study is to determine whether ACE inhibitors alter the fibrinolytic, inflammatory, and hemodynamic response to cardiopulmonary bypass in infants and children with congenital heart disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACE inhibitor | Experimental | Patients already on an ACE inhibitor will continue it until the day of surgery |
|
| No ACE inhibitor | Experimental | Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angiotensin Converting Enzyme Inhibitor | Drug | Patients randomized to this group will continue their current dose of ACE inhibitors until surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| (PAI-1) Plasminogen Activator Inhibitor -1 Antigen | Baseline (prior to surgery), On CPB for 30 minutes, At completion of CPB, and postoperative day 1 (at 8:00AM)postoperative day 1 | |
| t-PA (Tissue-type Plasminogen Activator) Antigen | Baseline (prior to surgery) to postoperative day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| IL-6 (Interleukin-6) | Baseline (pre-surgery) to postoperative day 1 | |
| IL-8 (Interleukin-8) | Baseline (pre-surgery) to postoperative day 1 | |
| (MAP) Mean Arterial Blood Pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory A Fleming, MD | Vanderbilt University Medical Center, Division of Pediatric Cardiology | Principal Investigator |
| Mias Pretorius, MBChB, MSCI | Vanderbilt University Medical Center, Department of Anesthesiology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232 | United States |
29 participants were eligible, 8 refused participation
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| ID | Title | Description |
|---|---|---|
| FG000 | ACE Inhibitor | Patients already on an ACE inhibitor will continue it until the day of surgery Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery |
| FG001 | No ACE Inhibitor | Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ACE Inhibitor | Patients already on an ACE inhibitor will continue it until the day of surgery Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery |
| BG001 | No ACE Inhibitor |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | (PAI-1) Plasminogen Activator Inhibitor -1 Antigen | Posted | Mean | Standard Error | ng/ml | Baseline (prior to surgery), On CPB for 30 minutes, At completion of CPB, and postoperative day 1 (at 8:00AM)postoperative day 1 |
|
From the start of surgery until hospital discharge, approximately 7 days
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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 | ACE Inhibitor | Patients already on an ACE inhibitor will continue it until the day of surgery Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ECMO | Cardiac disorders | Systematic Assessment | Extracorporeal membrane oxygenation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Permanent pacemaker | Cardiac disorders | Systematic Assessment | Did the patient require a permanent pacemaker after surgery? |
While patients were randomized to preoperative ACE inhibition, the present study was neither blinded nor placebo-controlled. However, the dose and type of ACE inhibitor were similar between the two study groups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mias Pretorius | Vanderbilt University Medical Center | 615-8757402 | mias.pretorius@vanderbilt.edu |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| ID | Term |
|---|---|
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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| No ACE Inhibitor | Other | Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery |
|
| Baseline (prior to surgery) to postoperative day 1 |
| Postoperative Bleeding | Chest tube output at 4 and 24 hours after completion of surgery | 24 hours |
| Postoperative Renal Function | Acute kidney injury occurring | Baseline (prior to surgery) to postoperative day 1 |
Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery |
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
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| Primary | t-PA (Tissue-type Plasminogen Activator) Antigen | Posted | Mean | Standard Error | ng/ml | Baseline (prior to surgery) to postoperative day 1 |
|
|
|
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| Secondary | IL-6 (Interleukin-6) | Posted | Mean | Standard Error | pg/ml | Baseline (pre-surgery) to postoperative day 1 |
|
|
|
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| Secondary | IL-8 (Interleukin-8) | Posted | Mean | Standard Error | pg/mL | Baseline (pre-surgery) to postoperative day 1 |
|
|
|
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| Secondary | (MAP) Mean Arterial Blood Pressure | Posted | Mean | Standard Error | mmHg | Baseline (prior to surgery) to postoperative day 1 |
|
|
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| Secondary | Postoperative Bleeding | Chest tube output at 4 and 24 hours after completion of surgery | Posted | Mean | Standard Error | mL/kg | 24 hours |
|
|
|
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| Secondary | Postoperative Renal Function | Acute kidney injury occurring | Posted | Number | Percentage of subject with AKI | Baseline (prior to surgery) to postoperative day 1 |
|
|
|
|
| 0 |
| 11 |
| 4 |
| 11 |
| 4 |
| 11 |
| EG001 | No ACE Inhibitor | Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery | 0 | 9 | 2 | 9 | 0 | 9 |
| Surgical re-exploration | Surgical and medical procedures | Systematic Assessment |
|
|
| Pleural effusion | Cardiac disorders | Systematic Assessment | Did the patient develop a pleural effusion? |
|
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020164 | Chemical Actions and Uses |
| At completion of CPB |
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| postoperative day 1 (at 8:00AM) |
|
| At completion of CPB |
|
| postoperative day 1 (at 8:00AM) |
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| Admission to ICU following surgery |
|
| postoperative day 1 (at 8:00AM) |
|
| At completion of CPB |
|
| postoperative day 1 (at 8:00AM) |
|