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NCT00626756 Clinical Trial

Lithium Dilution Method in Guiding Fluid Therapy in Critically Ill Patients

Critical Illness Clinical Trial

— LIGA  

Official title:
LIGA Trial-Lithium Dilution Method in Guiding Fluid Therapy in Critically Ill Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00626756
Other study ID # LigaStudy
Secondary ID LIGA2008
Status Recruiting
Phase N/A
First received February 21, 2008
Last updated February 28, 2008
Start date January 2008

Study information
Verified date February 2008
Source ASQA a.s.
Contact Vladimir Cerny, MD
Email cernyvla@fnhk.cz
Is FDA regulated No
Health authority Czech Republic: State Institute for Drug Control
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 15
Est. completion date
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Intervention

Device:
• LiDCO technology
non invasive monitoring of cardiac output

Locations
Country Name City State
Czech Republic ASQA a.s. Prague

Sponsors (1)
Lead Sponsor Collaborator
ASQA a.s.

Country where clinical trial is conducted

Czech Republic, 

References & Publications (5)

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. — View Citation

Price J, Sear J, Venn R. Perioperative fluid volume optimization following proximal femoral fracture. Cochrane Database Syst Rev. 2002;(1):CD003004. Review. — View Citation

Price JD, Sear JW, Venn RM. Perioperative fluid volume optimization following proximal femoral fracture. Cochrane Database Syst Rev. 2004;(1):CD003004. Review. Update in: Cochrane Database Syst Rev. 2013;9:CD003004. — View Citation

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. — View Citation

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. Epub 2005 Sep 9. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary positive or negative fluid balance one year No
Secondary effect of LiDCO monitoring on cumulative fluid balance one year No
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