Lithium Dilution Method in Guiding Fluid Therapy in Critically Ill Patients (LIGA)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by ASQA a.s..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
ASQA a.s.
Information provided by:
ASQA a.s.
ClinicalTrials.gov Identifier:
NCT00626756
First received: February 21, 2008
Last updated: February 28, 2008
Last verified: February 2008
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 21, 2008 | ||||||||
| Last Updated Date | February 28, 2008 | ||||||||
| Start Date ICMJE | January 2008 | ||||||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
positive or negative fluid balance [ Time Frame: one year ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00626756 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
effect of LiDCO monitoring on cumulative fluid balance [ Time Frame: one year ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Lithium Dilution Method in Guiding Fluid Therapy in Critically Ill Patients | ||||||||
| Official Title ICMJE | LIGA Trial-Lithium Dilution Method in Guiding Fluid Therapy in Critically Ill Patients | ||||||||
| Brief Summary | Hypothesis: Fluid management guided by LiDCO doesn´t increase cumulative fluid balance and shorten organ dysfunction compared to fluid management based on CVP and clinical judgment. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Condition ICMJE | Critical Illness | ||||||||
| Intervention ICMJE | Device: LiDCO technology
non invasive monitoring of cardiac output |
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| Study Arm (s) |
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| Publications * |
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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 | 15 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Czech Republic | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00626756 | ||||||||
| Other Study ID Numbers ICMJE | LigaStudy, LIGA2008 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Pavel Valek M.D., ASQA a.s. | ||||||||
| Study Sponsor ICMJE | ASQA a.s. | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | ASQA a.s. | ||||||||
| Verification Date | February 2008 | ||||||||
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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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