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

February 28, 2008 updated by: ASQA a.s.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Prague, Czech Republic, 106 00
        • Recruiting
        • ASQA a.s.
        • Contact:
        • Principal Investigator:
          • Vladimir Cerny, MD, PhD, FCCM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LI
arm controled by LIDCO technology
Device: LiDCO technology
non invasive monitoring of cardiac output
NO_INTERVENTION: CA
standard approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
positive or negative fluid balance
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
effect of LiDCO monitoring on cumulative fluid balance
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ASQA a.s.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ANTICIPATED)

December 1, 2008

Study Registration Dates

First Submitted

February 21, 2008

First Submitted That Met QC Criteria

February 28, 2008

First Posted (ESTIMATE)

February 29, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 29, 2008

Last Update Submitted That Met QC Criteria

February 28, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LigaStudy
  • LIGA2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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