Critical IllnessLIGANCT00626756
Lithium Dilution Method in Guiding Fluid Therapy in Critically Ill Patients
A study testing LiDCO technology in people with Critical Illness, run by ASQA a.s. at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- LiDCO technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2008to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age
- Needs for fluid chalange
- Invasive ventilatory supportinvasive blood pressure monitoring
- Lidco monitoring
- Central venous catheter
Who cannot join
- DNR
- Need for CRRT
- Head injury
Trial locations and contacts
1 site in 1 country.
Vladimir Cerny, MD contact
Czechia1 site, 1 recruiting
- Recruiting
ASQA a.s.
Prague, 106 00
Pavel Valek, MD, +420272761350, pavel.valek@asqa.cz
Vladimir Cerny, MD, PhD, FCCM
About this study
Official title: 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.
- Conditions
- Critical Illness
- Being tested
- LiDCO technology
- Keywords
- fluid, Lidco technology, guided therapy, fluid management guided by Lidco technology
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiDCO technologyDevice
non invasive monitoring of cardiac output
| Study group | Role | What they receive |
|---|---|---|
| LI | Experimental | arm controled by LIDCO technology Receives: Device: LiDCO technology |
| CA | No intervention | standard approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive or negative fluid balance
Measured: one year
Secondary outcomes (1)
effect of LiDCO monitoring on cumulative fluid balance
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ASQA a.s.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Vladimir Cerny, MD, PhD, FCCM, Principal investigator, University Hospital Hradec Kralove
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626756
- Sponsor's protocol ID
- LigaStudy
- Other IDs
- LIGA2008
- Acronym
- LIGA
- Status last verified
- Feb 2008
- First submitted
- 21 Feb 2008
- Last updated
- 29 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1136/bmj.315.7113.909.
PubMed 9361539Wakeling 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.
PubMed 16155038Price 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.
PubMed 11869649Price 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.
PubMed 14974001Conway 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.
PubMed 12190747
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIGA Trial-Lithium Dilution Method in Guiding Fluid Therapy in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT00626756
- Acronym / sponsor ID
- LIGA / LigaStudy
- Conditions
- Critical Illness
- Keywords
- fluid, Lidco technology, guided therapy, fluid management guided by Lidco technology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- ASQA a.s.Industry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (estimated)
- First posted
- 29 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LI | Experimental | Device: LiDCO technologyarm controled by LIDCO technology |
| CA | No intervention | –standard approach |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age
- Needs for fluid chalange
- Invasive ventilatory supportinvasive blood pressure monitoring
- Lidco monitoring
- Central venous catheter
Key exclusion criteria (3 listed)
- DNR
- Need for CRRT
- Head injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiDCO technologynon invasive monitoring of cardiac output | Device | LI |
Primary outcome
positive or negative fluid balance
Time frame: one year
1 secondary outcome
effect of LiDCO monitoring on cumulative fluid balance
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2008.
- Background: PubMed 9361539Sinclair 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.
- Background: PubMed 16155038Wakeling 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.
- Background: PubMed 11869649Price 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.
- Background: PubMed 14974001Price 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.
- Background: PubMed 12190747Conway 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir Cerny, MD contact
Vladimir Cerny, MD, PhD, FCCM principal investigator
University Hospital Hradec Kralove
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LiDCO technology in people with Critical Illness, run by ASQA a.s. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vladimir Cerny, MD (cernyvla@fnhk.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive or negative fluid balance (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00626756, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2008.