Effect of Prime Solution on Fluid Balance After Open Heart Surgery
This study is currently recruiting participants.
Verified February 2009 by Helsinki University
Sponsor:
Helsinki University
Collaborator:
B. Braun Melsungen AG
Information provided by:
Helsinki University
ClinicalTrials.gov Identifier:
NCT00797589
First received: November 24, 2008
Last updated: June 24, 2011
Last verified: February 2009
| Tracking Information | |||||
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| First Received Date ICMJE | November 24, 2008 | ||||
| Last Updated Date | June 24, 2011 | ||||
| Start Date ICMJE | January 2009 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
fluid balance [ Time Frame: 1 postoperative day ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00797589 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 | Effect of Prime Solution on Fluid Balance After Open Heart Surgery | ||||
| Official Title ICMJE | Effect of Prime Solution on Fluid Balance After Open Heart Surgery | ||||
| Brief Summary | The use of Tetraspan® as prime solution can reduce fluid extravasation after perfusion versus Ringer acetate. Plasma-adapted HES-solutions produce also less acidosis. |
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| Detailed Description | Fifty patients scheduled for elective primary and single cardiac surgery include in this prospective study. Patients with preoperative coagulation disorders, or renal or hepatic failure, are excluded. Before admission to the operation theatre, the patients allocate in random order to receive one of the following solutions during the extracorporeal circulation:
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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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 | 50 | ||||
| Estimated Completion Date | December 2014 | ||||
| Estimated Primary Completion Date | December 2013 (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 | NCT00797589 | ||||
| Other Study ID Numbers ICMJE | 2008-001225-34 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Raili Suojaranta-Ylinen / MD, PhD, Helsinki University Central Hospital | ||||
| Study Sponsor ICMJE | Helsinki University | ||||
| Collaborators ICMJE | B. Braun Melsungen AG | ||||
| Investigators ICMJE |
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| Information Provided By | Helsinki University | ||||
| Verification Date | February 2009 | ||||
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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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