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NCT02620761 · ClinicalTrials.gov registry record · Phase 2
Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants
A Phase 2 study, sponsored by Medical College of Wisconsin.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT02620761 is a Phase 2 study that was terminated before completion, run by Medical College of Wisconsin. The registered enrollment target is 1 participants.
The verdict
NCT02620761, a Phase 2 study, was terminated before completion, sponsored by Medical College of Wisconsin.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
The investigators will conduct a prospective, blinded, randomized, placebo-controlled trial with a sample size of 20 patients in each of the two arms (fenoldopam vs placebo) based upon a difference in serum creatinine by one standard deviation. Fluid and salt intake will be held constant within clinical parameters and carefully measured. Fenoldopam will be started at 0.1 ug/kg/min. If, after 6 hrs there is no decrease in blood pressure, the dose will be increased to 0.2 ug/kg/min. This dose will be continued throughout the remainder of the study. A study of pediatric patients previously provided to the FDA showed no hypotension at a dose of 0.2 ug/kg/min. Fenoldopam will be started 12 hrs before the first dose of indomethacin and discontinued 12 hrs after the 3rd dose of indomethacin. Study samples will include both blood and urine. The primary outcome will be a reduction in renal dysfunction, as determined by creatinine and urine output over the course of treatment. Additional outcomes will include determination of known and novel metabolomic urine markers of renal dysfunction.
Interventions
- DRUG Fenoldopam
- DRUG 0.9%NS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2019-02-06 |
| Est. Completion | 2020-01-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02620761
The ClinicalTrials.gov registry entry for NCT02620761 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Fenoldopam is the first listed.
NCT02620761 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02620761 about?
NCT02620761 is a clinical study titled "Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants". The investigators will conduct a prospective, blinded, randomized, placebo-controlled trial with a sample size of 20 patients in each of the two arms (fenoldopam vs placebo) based upon a difference in serum creatinine by one standard deviation. Fluid and salt intake will be held constant within clin...
What is the current status of trial NCT02620761?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2019-02-06. Estimated completion is 2020-01-31.
What interventions are being tested in trial NCT02620761?
The interventions under investigation include: Fenoldopam (DRUG), 0.9%NS (DRUG).
Who is sponsoring clinical trial NCT02620761?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
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