LIGA: Lithium Dilution Method in Guiding Fluid Therapy in Critically Ill Patients

• Sponsor: ASQA a.s. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT00626756
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness	Device: LiDCO technology	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: LIGA Trial-Lithium Dilution Method in Guiding Fluid Therapy in Critically Ill Patients
• Study Start Date: Jan 1, 2008
• Anticipated Primary Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LI arm controled by LIDCO technology	Device: LiDCO technology; non invasive monitoring of cardiac output
No Intervention: CA standard approach

Outcome Measures

Primary Outcome Measures

1. positive or negative fluid balance [one year]

Secondary Outcome Measures

1. effect of LiDCO monitoring on cumulative fluid balance [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	ASQA a.s.	Prague		Czech Republic	106 00

Sponsors and Collaborators

• ASQA a.s.

Investigators

• Principal Investigator: Vladimir Cerny, MD, PhD, FCCM, University Hospital Hradec Kralove

Study Documents (Full-Text)

None provided.

More Information

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.
• 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. Update in: Cochrane Database Syst Rev. 2013;9:CD003004.
• 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.

• ClinicalTrials.gov Identifier: NCT00626756
• Other Study ID Numbers: LigaStudy; LIGA2008
• First Posted: Feb 29, 2008
• Last Update Posted: Feb 29, 2008
• Last Verified: Feb 1, 2008

• Keywords provided by , ,: fluid; Lidco technology; guided therapy; fluid management guided by Lidco technology
• Additional relevant MeSH terms: Critical Illness

Study Results

No Results Posted as of Feb 29, 2008