- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00626756
Lithium Dilution Method in Guiding Fluid Therapy in Critically Ill Patients (LIGA)
February 28, 2008 updated by: ASQA a.s.
LIGA Trial-Lithium Dilution Method in Guiding Fluid Therapy in Critically Ill Patients
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Vladimir Cerny, MD
- Email: cernyvla@fnhk.cz
Study Contact Backup
- Name: Pavel Valek, MD
- Phone Number: +420272761350
- Email: pavel.valek@asqa.cz
Study Locations
-
-
-
Prague, Czech Republic, 106 00
- Recruiting
- ASQA a.s.
-
Contact:
- Pavel Valek, MD
- Phone Number: +420272761350
- Email: pavel.valek@asqa.cz
-
Principal Investigator:
- Vladimir Cerny, MD, PhD, FCCM
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age
- Needs for fluid chalange
- Invasive ventilatory supportinvasive blood pressure monitoring
- Lidco monitoring
- Central venous catheter
Exclusion Criteria:
- DNR
- Need for CRRT
- Head injury
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: LI
arm controled by LIDCO technology
|
non invasive monitoring of cardiac output
|
NO_INTERVENTION: CA
standard approach
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
positive or negative fluid balance
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
effect of LiDCO monitoring on cumulative fluid balance
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Conway DH, Mayall R, Abdul-Latif MS, Gilligan S, Tackaberry C. Randomised controlled trial investigating the influence of intravenous fluid titration using oesophageal Doppler monitoring during bowel surgery. Anaesthesia. 2002 Sep;57(9):845-9. doi: 10.1046/j.1365-2044.2002.02708.x.
- Sinclair S, James S, Singer M. Intraoperative intravascular volume optimisation and length of hospital stay after repair of proximal femoral fracture: randomised controlled trial. BMJ. 1997 Oct 11;315(7113):909-12. doi: 10.1136/bmj.315.7113.909.
- Wakeling HG, McFall MR, Jenkins CS, Woods WG, Miles WF, Barclay GR, Fleming SC. Intraoperative oesophageal Doppler guided fluid management shortens postoperative hospital stay after major bowel surgery. Br J Anaesth. 2005 Nov;95(5):634-42. doi: 10.1093/bja/aei223. Epub 2005 Sep 9.
- Price JD, Sear JW, Venn RM. Perioperative fluid volume optimization following proximal femoral fracture. Cochrane Database Syst Rev. 2004;(1):CD003004. doi: 10.1002/14651858.CD003004.pub2.
- Price J, Sear J, Venn R. Perioperative fluid volume optimization following proximal femoral fracture. Cochrane Database Syst Rev. 2002;(1):CD003004. doi: 10.1002/14651858.CD003004.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (ANTICIPATED)
December 1, 2008
Study Registration Dates
First Submitted
February 21, 2008
First Submitted That Met QC Criteria
February 28, 2008
First Posted (ESTIMATE)
February 29, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
February 29, 2008
Last Update Submitted That Met QC Criteria
February 28, 2008
Last Verified
February 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LigaStudy
- LIGA2008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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