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

History of Changes

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

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:

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.

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.

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

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

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.

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 May 16, 2013

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