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NCT00459082
A Pharmacokinetic Study of Dexmedetomine in Infants
Phase 1 trial testing Dexmedetomine in Cardiac Surgical Procedures in 36 participants. Completed in 1 November 2006.
Quick facts
| Lead sponsor | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 1 May 2004 |
| Estimated completion | 1 November 2006 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Dexmedetomine — full drug profile →
Conditions studied
- Cardiac Surgical Procedures — all drugs for Cardiac Surgical Procedures →
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Who can join
Adults 1 Month to 24 Months, any sex, with Cardiac Surgical Procedures. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- Pharmacodynamics: vital signs, cardiac rhythm, oxygen saturation, laboratory evaluations and adverse events will be monitored to determine the safety of dexmedetomine.
- Pharmacokinetics: will measure plasma concentrations for dose escalations of dexmedetomine to determine the maximum tolerated dose (MTD).
Sponsor's own description
Blind randomized trial of a single bolus dose of dexmedetomine followed by a continuous infusion (CIVI) for up to 24 hours in infants who immediately post-operative from cardiac surgery and require tracheal intubation with mechanical ventilation in the post-operative period. Three bolus and infusion dose will be administered to a total of 36 patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00459082
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cardiac Surgical Procedures
Currently open trials in the same condition.
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- NCT06318689 — In Situ Exploration of Vascular Function in Vasoplegic Shock Following Cardiac Surgery With Cardiopulmonary Bypass · recruiting
- NCT04244981 — Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery · Phase 4 · recruiting
Other Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) trials
Trials by the same sponsor.
- NCT07502586 — Turner Syndrome: Genetic Considerations · recruiting
- NCT07357701 — Identifying Genome Variants in Non-Obstructive Azoospermia (NOA) or Primary Ovarian Insufficiency (POI) · recruiting
- NCT06851754 — Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency · Phase 3 · recruiting
- NCT05548881 — Implications of Maternal 45,X Mosaicism as a Secondary Genomic Finding Following Cell-Free DNA Sequencing During Pregnan · withdrawn
- NCT06749366 — Uncovering Genes Behind Cartilage Tumors and Vascular Anomalies Using Genomic Sequencing · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00459082 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Last refreshed: 10 April 2007
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00459082.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing