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Lithium Dilution Method in Guiding Fluid Therapy in Critically Ill Patients (LIGA)

Primary Purpose

Critical Illness

Status
Unknown status
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
LiDCO technology
Sponsored by
ASQA a.s.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Critical Illness focused on measuring fluid, Lidco technology, guided therapy, fluid management guided by Lidco technology

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ASQA a.s.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

LI

CA

Arm Description

arm controled by LIDCO technology

standard approach

Outcomes

Primary Outcome Measures

positive or negative fluid balance

Secondary Outcome Measures

effect of LiDCO monitoring on cumulative fluid balance

Full Information

First Posted
February 21, 2008
Last Updated
February 28, 2008
Sponsor
ASQA a.s.
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1. Study Identification

Unique Protocol Identification Number
NCT00626756
Brief Title
Lithium Dilution Method in Guiding Fluid Therapy in Critically Ill Patients
Acronym
LIGA
Official Title
LIGA Trial-Lithium Dilution Method in Guiding Fluid Therapy in Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
ASQA a.s.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
fluid, Lidco technology, guided therapy, fluid management guided by Lidco technology

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LI
Arm Type
Experimental
Arm Description
arm controled by LIDCO technology
Arm Title
CA
Arm Type
No Intervention
Arm Description
standard approach
Intervention Type
Device
Intervention Name(s)
LiDCO technology
Intervention Description
non invasive monitoring of cardiac output
Primary Outcome Measure Information:
Title
positive or negative fluid balance
Time Frame
one year
Secondary Outcome Measure Information:
Title
effect of LiDCO monitoring on cumulative fluid balance
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vladimir Cerny, MD
Email
cernyvla@fnhk.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Pavel Valek, MD
Phone
+420272761350
Email
pavel.valek@asqa.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir Cerny, MD, PhD, FCCM
Organizational Affiliation
University Hospital Hradec Kralove
Official's Role
Principal Investigator
Facility Information:
Facility Name
ASQA a.s.
City
Prague
ZIP/Postal Code
106 00
Country
Czech Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavel Valek, MD
Phone
+420272761350
Email
pavel.valek@asqa.cz
First Name & Middle Initial & Last Name & Degree
Vladimir Cerny, MD, PhD, FCCM

12. IPD Sharing Statement

Citations:
PubMed Identifier
9361539
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. doi: 10.1136/bmj.315.7113.909.
Results Reference
background
PubMed Identifier
16155038
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. doi: 10.1093/bja/aei223. Epub 2005 Sep 9.
Results Reference
background
PubMed Identifier
11869649
Citation
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.
Results Reference
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PubMed Identifier
14974001
Citation
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.
Results Reference
background
PubMed Identifier
12190747
Citation
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.
Results Reference
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Lithium Dilution Method in Guiding Fluid Therapy in Critically Ill Patients

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