Trial · NCT00281671
Nesiritide Use Following Cardiac Surgery in Infants
NCT00281671, Phase 1, Phase 2, Terminated, Boston Children's Hospital; results first posted 2020-08-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nesiritide Use Following Cardiac Surgery in Infants. Trials, record NCT00281671. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00281671
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nesiritide Use Following Cardiac Surgery in Infants
- NCT number
- NCT00281671
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- Boston Children's Hospital
- Conditions
- Heart Defects, Congenital, Cardiopulmonary Bypass
- Interventions
- nesiritide, Placebo
- First posted
- 2006-01-25
- Last updated
- 2020-08-27
- Results first posted
- 2020-08-27
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Urine Output | 5 hours | Urine output measured in cc/kg/hour during the last 5 hours of the study drug infusion |
| Secondary | Number of Participants With Hypotension and Bradycardia | 48 hours | Hypotension (mean arterial blood pressure \< 40 mmHg for \> 30 minutes) that is refractory to volume administration, increased inotropic/vasopressor support, and weaning of other vasodilators (e.g., milrinone) or sedatives Bradycardia, defined as 1) a decrease in heart rate of more than 30 beats/minute from baseline following the initiation of study drug infusion that 2) results in new requirement for temporary atrial pacing or other treatment specifically to increase heart rate and 3) is not readily explainable by other conditions. |
| Secondary | Urine Output | 10 hours | |
| Secondary | Cardiac Index | Baseline (hour 0) and 6 hours after onset of study drug infusion | Cardiac index is based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m\^2) to yield the cardiac index. Cardiac index was calculated in patients with an SVC catheter (previously placed for clinical indications) using the Fick principle using measured oxygen consumption (VO2), hemoglobin levels, and the difference between arterial and superior vena cava oxygen saturation. Oxygen consumption was measured using a real-time gas exchange technique with the Deltatrack II gas sensor. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Urine Output | 5 hours | cc/kg/hr | MEDIAN | |
| SECONDARY | Number of Participants With Hypotension and Bradycardia | 48 hours | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Urine Output | 10 hours | cc/kg/hr | MEDIAN | |
| SECONDARY | Cardiac Index | Baseline (hour 0) and 6 hours after onset of study drug infusion | Cardiac index was only able to be measured for 4 of the 9 subjects enrolled in the trial. | L/min/m^2 | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Urine Output | Placebo | 2.9 | Full Range 1.1 to 7.1 | cc/kg/hr | |
| Urine Output | Nesiritide | 3.1 | Full Range 0.6 to 6.4 | cc/kg/hr | |
| Number of Participants With Hypotension and Bradycardia | Placebo | hypotension | 0 | Participants | |
| Number of Participants With Hypotension and Bradycardia | Nesiritide | hypotension | 0 | Participants | |
| Number of Participants With Hypotension and Bradycardia | Placebo | bradycardia | 0 | Participants | |
| Number of Participants With Hypotension and Bradycardia | Nesiritide | bradycardia | 0 | Participants | |
| Urine Output | Placebo | 3.4 | Full Range 1.1 to 6.0 | cc/kg/hr | |
| Urine Output | Nesiritide | 4.2 | Full Range 1.3 to 5.7 | cc/kg/hr | |
| Cardiac Index | Placebo | baseline | 1.83 | Full Range 0.95 to 3.61 | L/min/m^2 |
| Cardiac Index | Nesiritide | baseline | 1.90 | Full Range 1.50 to 3.26 | L/min/m^2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nesiritide First, Then Placebo | 5 | |
| Overall Study | STARTED | Placebo First, Then Nesiritide | 4 | |
| Overall Study | COMPLETED | Nesiritide First, Then Placebo | 5 | |
| Overall Study | COMPLETED | Placebo First, Then Nesiritide | 4 | |
| Overall Study | NOT COMPLETED | Nesiritide First, Then Placebo | 0 | |
| Overall Study | NOT COMPLETED | Placebo First, Then Nesiritide | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nesiritide | 0 | 9 |
| Total, all-cause mortality | Placebo | 0 | 9 |
| Total, other adverse events | Nesiritide | 0 | 9 |
| Total, other adverse events | Placebo | 0 | 9 |
| Total, serious adverse events | Nesiritide | 0 | 9 |
| Total, serious adverse events | Placebo | 0 | 9 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|
| Nesiritide vs Placebo: deaths from any cause | Trial comparisons |
| Nesiritide vs Placebo: 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/NCT00281671
GET https://conductscience.org/api/trials/v1/NCT00281671/registered