Trial · NCT02620761
Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants
NCT02620761, Phase 2, Phase 3, Terminated, Medical College of Wisconsin; results first posted 2022-09-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants. Trials, record NCT02620761. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02620761
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants
- NCT number
- NCT02620761
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 1 participants, actual
- Lead sponsor
- Medical College of Wisconsin
- Conditions
- Patent Ductus Arteriosus (PDA), Acute Kidney Injury (AKI)
- Interventions
- Fenoldopam, 0.9%NS
- First posted
- 2015-12-03
- Last updated
- 2022-09-16
- Results first posted
- 2022-09-16
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in Urine Output (ml/kg/hr) | 66 hrs - from 6 hrs before beginning of fenoldopam or placebo infusion up to 24 hours after the last dose of indomethacin | Urine will be collected and measured in 6 hour increments beginning 6 hours prior to starting fenoldopam or placebo infusion. The first dose of indomethacin will be given 12 hours after starting fenoldopam or placebo. Two additional doses of indomethacin will be given 12 hours apart. Urine will continue to be collected and volume measured in 6 hour increments up to 24 hrs after the last dose of indomethacin. To summarize, urine will be collected and measured from time -6 hours to 0 hours. Fenoldapam or placebo will be initiated at time 0 hrs, indomethacin given at time 12, 24 and 36 hours, and urine collected and measured to time 60 hours. |
| Primary | Serum Levels of Fenoldopam During Infusion of the Drug and Following Discontinuation of the Drug Will be Measured by Liquid Chromatography and Mass Spectroscopy. | 60 hours | Blood samples for determination of serum fenoldopam levels will be obtained immediately prior to starting the infusion of fenoldopam (time 0 hour), continue through the 48 hour period of fenoldopam infusion and continue for an additional 12 hours after stopping the fenoldopam infusion. |
| Primary | Change in Levels of Serum Albumin (mg/dl) | 48 hrs | Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period |
| Primary | Changes in Serum Creatinine (mg/dl) | 48 hours | Serum creatinine will be measured immediately prior to first dose of indomethacin, immediately prior to the third dose of indomethacin (24 hr later) and 24 hours after the third dose of indomethacin |
| Primary | Serum Levels of Fenoldopam Will be Related the Changes in Urine Volume | 60 hours | We will relate serum levels of fenoldopam to changes in urine volume over the duration of time of fenoldopam infusion and after discontinuation of infusion. This constitutes part of the pharmacodynamic analysis |
| Primary | Serum Levels of Fenoldopam Will be Related to Absolute and Relative Changes in Serum Creatinine | 60 hours | We will relate serum levels of fenoldopam to serum creatinine values over the duration of time of fenoldopam infusion and after discontinuation of infusion. This constitutes part of the pharmacodynamic analysis |
| Primary | Change in Levels of Serum Beta 2 Macroglobulin (mcg/ml) | 48 hrs | Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period |
| Primary | Change in Levels of Serum Cystatin C (mcg/ml) | 48 hrs | Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period |
| Primary | Change in Levels of Serum Epidermal Growth Factor (EGF) (ng/ml) | 48 hrs | Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period |
| Primary | Change in Levels of Serum Osteopontin (ng/ml) | 48 hrs | Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Changes in Urine Output (ml/kg/hr) | 66 hrs - from 6 hrs before beginning of fenoldopam or placebo infusion up to 24 hours after the last dose of indomethacin | No analysis performed as only single patient was enrolled | ||
| PRIMARY | Serum Levels of Fenoldopam During Infusion of the Drug and Following Discontinuation of the Drug Will be Measured by Liquid Chromatography and Mass Spectroscopy. | 60 hours | No analysis performed as only single patient was enrolled | ||
| PRIMARY | Change in Levels of Serum Albumin (mg/dl) | 48 hrs | No analysis performed as only single patient was enrolled | ||
| PRIMARY | Changes in Serum Creatinine (mg/dl) | 48 hours | No analysis performed as only single patient was enrolled | ||
| PRIMARY | Serum Levels of Fenoldopam Will be Related the Changes in Urine Volume | 60 hours | No analysis performed as only single patient was enrolled | ||
| PRIMARY | Serum Levels of Fenoldopam Will be Related to Absolute and Relative Changes in Serum Creatinine | 60 hours | No analysis performed as only single patient was enrolled | ||
| PRIMARY | Change in Levels of Serum Beta 2 Macroglobulin (mcg/ml) | 48 hrs | No analysis performed as only single patient was enrolled | ||
| PRIMARY | Change in Levels of Serum Cystatin C (mcg/ml) | 48 hrs | No analysis performed as only single patient was enrolled | ||
| PRIMARY | Change in Levels of Serum Epidermal Growth Factor (EGF) (ng/ml) | 48 hrs | No analysis performed as only single patient was enrolled | ||
| PRIMARY | Change in Levels of Serum Osteopontin (ng/ml) | 48 hrs | No analysis performed as only single patient was enrolled |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Control | 1 | |
| Overall Study | STARTED | Fenoldopam | 0 | |
| Overall Study | COMPLETED | Control | 1 | |
| Overall Study | COMPLETED | Fenoldopam | 0 | |
| Overall Study | NOT COMPLETED | Control | 0 | |
| Overall Study | NOT COMPLETED | Fenoldopam | 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 | Control | 0 | 1 |
| Total, all-cause mortality | Fenoldopam | 0 | 0 |
| Total, other adverse events | Control | 0 | 1 |
| Total, other adverse events | Fenoldopam | 0 | 0 |
| Total, serious adverse events | Control | 0 | 1 |
| Total, serious adverse events | Fenoldopam | 0 | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39607014 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02620761
GET https://conductscience.org/api/trials/v1/NCT02620761/registered