Dexmedetomidine Pharmacokinetics During Continuous Renal Replacement Therapy (CRRT)
This study is currently recruiting participants.
Verified March 2011 by Helsinki University Central Hospital
Sponsor:
Helsinki University Central Hospital
Information provided by:
Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01314209
First received: March 8, 2011
Last updated: October 23, 2012
Last verified: March 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 8, 2011 | ||||||||
| Last Updated Date | October 23, 2012 | ||||||||
| Start Date ICMJE | March 2011 | ||||||||
| Estimated Primary Completion Date | March 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Dexmedetomidine clearance by continuous venovenous hemodialysis [ Time Frame: 10 hours from the start of the dexmedetomidine infusion ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Dexmedetomidine clearance by continuous venovenous hemofiltration and hemodiafiltration [ Time Frame: 12 hours from the start of the dexmedetomidine infusion ] [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT01314209 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Dexmedetomidine Pharmacokinetics During Continuous Renal Replacement Therapy (CRRT) | ||||||||
| Official Title ICMJE | Dexmedetomidine Pharmacokinetics During Continuous Venovenous Hemodialysis in Critically Ill Patients | ||||||||
| Brief Summary | The purpose of this study is to determine dexmedetomidine pharmacokinetics during continuous renal replacement therapy on critically ill patients. |
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| Detailed Description | Dexmedetomidine is a selective alpha-2-adrenergic agonist with sedative properties indicated for sedation of patients in the intensive care setting. ICU patients with acute kidney injury requiring renal replacement therapies frequently have changes in volume status causing alterations in drug pharmacokinetics. Although dexmedetomidine pharmacokinetics have been studied earlier on ICU patients, there is no information on its pharmacokinetics in critically ill patients needing continuous renal replacement therapy. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Acute Kidney Injury | ||||||||
| Intervention ICMJE | Drug: Dexmedetomidine
Dexmedetomidine 0.7 microg/kg/h 12-hour intravenous infusion |
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| Study Arm (s) | Experimental: dexmedetomidine
Intervention: Drug: Dexmedetomidine |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 10 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | March 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Finland | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01314209 | ||||||||
| Other Study ID Numbers ICMJE | 11102010 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Kirsi-Maija Kaukonen, Division of Anaesthesia and Intensive Care Medicine, Department of Surgery, Helsinki University Central Hospital | ||||||||
| Study Sponsor ICMJE | Helsinki University Central Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Helsinki University Central Hospital | ||||||||
| Verification Date | March 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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