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
Sponsor:
Information provided by:
ASQA a.s.
ClinicalTrials.gov Identifier:
NCT00626756
First received: February 21, 2008
Last updated: February 28, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention
Critical Illness
Device: LiDCO technology

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: LIGA Trial-Lithium Dilution Method in Guiding Fluid Therapy in Critically Ill Patients

Further study details as provided by ASQA a.s.:

Primary Outcome Measures:
  • positive or negative fluid balance [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • effect of LiDCO monitoring on cumulative fluid balance [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: January 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LI
arm controled by LIDCO technology
Device: LiDCO technology
non invasive monitoring of cardiac output
No Intervention: CA
standard approach

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626756

Contacts
Contact: Vladimir Cerny, MD cernyvla@fnhk.cz
Contact: Pavel Valek, MD +420272761350 pavel.valek@asqa.cz

Locations
Czech Republic
ASQA a.s. Recruiting
Prague, Czech Republic, 106 00
Contact: Pavel Valek, MD    +420272761350    pavel.valek@asqa.cz   
Principal Investigator: Vladimir Cerny, MD, PhD, FCCM         
Sponsors and Collaborators
ASQA a.s.
Investigators
Principal Investigator: Vladimir Cerny, MD, PhD, FCCM University Hospital Hradec Kralove
  More Information

Publications:
Responsible Party: Pavel Valek M.D., ASQA a.s.
ClinicalTrials.gov Identifier: NCT00626756     History of Changes
Other Study ID Numbers: LigaStudy, LIGA2008
Study First Received: February 21, 2008
Last Updated: February 28, 2008
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by ASQA a.s.:
fluid
Lidco technology
guided therapy
fluid management guided by Lidco technology

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014