Trial · NCT00848250
Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children
NCT00848250, Not applicable, Completed, Vanderbilt University Medical Center; results first posted 2017-07-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children. Trials, record NCT00848250. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00848250
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children
- NCT number
- NCT00848250
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 21 participants, actual
- Lead sponsor
- Vanderbilt University Medical Center
- Conditions
- Congenital Heart Disease
- Interventions
- Angiotensin Converting Enzyme Inhibitor, No ACE Inhibitor
- First posted
- 2009-02-20
- Last updated
- 2017-07-26
- Results first posted
- 2017-07-26
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | (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 | |
| Primary | t-PA (Tissue-type Plasminogen Activator) Antigen | Baseline (prior to surgery) to postoperative day 1 | |
| Secondary | IL-6 (Interleukin-6) | Baseline (pre-surgery) to postoperative day 1 | |
| Secondary | IL-8 (Interleukin-8) | Baseline (pre-surgery) to postoperative day 1 | |
| Secondary | (MAP) Mean Arterial Blood Pressure | Baseline (prior to surgery) to postoperative day 1 | |
| Secondary | Postoperative Bleeding | 24 hours | Chest tube output at 4 and 24 hours after completion of surgery |
| Secondary | Postoperative Renal Function | Baseline (prior to surgery) to postoperative day 1 | Acute kidney injury occurring |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | (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 | ng/ml | MEAN | |
| PRIMARY | t-PA (Tissue-type Plasminogen Activator) Antigen | Baseline (prior to surgery) to postoperative day 1 | ng/ml | MEAN | |
| SECONDARY | IL-6 (Interleukin-6) | Baseline (pre-surgery) to postoperative day 1 | pg/ml | MEAN | |
| SECONDARY | IL-8 (Interleukin-8) | Baseline (pre-surgery) to postoperative day 1 | pg/mL | MEAN | |
| SECONDARY | (MAP) Mean Arterial Blood Pressure | Baseline (prior to surgery) to postoperative day 1 | mmHg | MEAN | |
| SECONDARY | Postoperative Bleeding | 24 hours | mL/kg | MEAN | |
| SECONDARY | Postoperative Renal Function | Baseline (prior to surgery) to postoperative day 1 | Percentage of subject with AKI | NUMBER |
Source ClinicalTrials.gov
Results by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| (PAI-1) Plasminogen Activator Inhibitor -1 Antigen | ACE Inhibitor | Baseline, Pre- Cardiopulmonary bypass (CPD) | 4.59 | Standard Error 2.36 | ng/ml |
| (PAI-1) Plasminogen Activator Inhibitor -1 Antigen | No ACE Inhibitor | Baseline, Pre- Cardiopulmonary bypass (CPD) | 3.78 | Standard Error 0.58 | ng/ml |
| (PAI-1) Plasminogen Activator Inhibitor -1 Antigen | ACE Inhibitor | at 30 minutes on CPB | 13.59 | Standard Error 2.8 | ng/ml |
| (PAI-1) Plasminogen Activator Inhibitor -1 Antigen | No ACE Inhibitor | at 30 minutes on CPB | 17.8 | Standard Error 2.49 | ng/ml |
| (PAI-1) Plasminogen Activator Inhibitor -1 Antigen | ACE Inhibitor | Completion of CPB | 54.74 | Standard Error 6.63 | ng/ml |
| (PAI-1) Plasminogen Activator Inhibitor -1 Antigen | No ACE Inhibitor | Completion of CPB | 58.56 | Standard Error 0.86 | ng/ml |
| (PAI-1) Plasminogen Activator Inhibitor -1 Antigen | ACE Inhibitor | postoperative day 1 (at 8:00AM) | 57.13 | Standard Error 12.14 | ng/ml |
| (PAI-1) Plasminogen Activator Inhibitor -1 Antigen | No ACE Inhibitor | postoperative day 1 (at 8:00AM) | 88.74 | Standard Error 14.02 | ng/ml |
| t-PA (Tissue-type Plasminogen Activator) Antigen | ACE Inhibitor | Baseline, Pre- Cardiopulmonary bypass (CPD) | 10.81 | Standard Error 1.0 | ng/ml |
| t-PA (Tissue-type Plasminogen Activator) Antigen | No ACE Inhibitor | Baseline, Pre- Cardiopulmonary bypass (CPD) | 8.31 | Standard Error 0.94 | ng/ml |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ACE Inhibitor | 11 | |
| Overall Study | STARTED | No ACE Inhibitor | 10 | |
| Overall Study | COMPLETED | ACE Inhibitor | 11 | |
| Overall Study | COMPLETED | No ACE Inhibitor | 9 | |
| Overall Study | NOT COMPLETED | ACE Inhibitor | 0 | |
| Overall Study | NOT COMPLETED | No ACE Inhibitor | 1 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Permanent pacemaker | Cardiac disorders | ACE Inhibitor | 1 | 11 | 1 |
| other | Permanent pacemaker | Cardiac disorders | No ACE Inhibitor | 0 | 9 | 0 |
| other | Pleural effusion | Cardiac disorders | ACE Inhibitor | 3 | 11 | 3 |
| other | Pleural effusion | Cardiac disorders | No ACE Inhibitor | 0 | 9 | 0 |
| serious | ECMO | Cardiac disorders | ACE Inhibitor | 1 | 11 | 1 |
| serious | ECMO | Cardiac disorders | No ACE Inhibitor | 0 | 9 | 0 |
| serious | Surgical re-exploration | Surgical and medical procedures | ACE Inhibitor | 3 | 11 | 3 |
| serious | Surgical re-exploration | Surgical and medical procedures | No ACE Inhibitor | 2 | 9 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ACE Inhibitor | 0 | 11 |
| Total, all-cause mortality | No ACE Inhibitor | 0 | 9 |
| Total, other adverse events | ACE Inhibitor | 4 | 11 |
| Total, other adverse events | No ACE Inhibitor | 0 | 9 |
| Total, serious adverse events | ACE Inhibitor | 4 | 11 |
| Total, serious adverse events | No ACE Inhibitor | 2 | 9 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ACE Inhibitor vs No ACE Inhibitor: deaths from any cause | Trial comparisons |
| ACE Inhibitor vs No ACE Inhibitor: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00848250
GET https://conductscience.org/api/trials/v1/NCT00848250/results?page=2