NCT00626756

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 29, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Last Updated

February 29, 2008

Status Verified

February 1, 2008

Enrollment Period

11 months

First QC Date

February 21, 2008

Last Update Submit

February 28, 2008

Conditions

Critical Illness

Keywords

fluidLidco technologyguided therapyfluid management guided by Lidco technology

Outcome Measures

Primary Outcomes (1)

  • positive or negative fluid balance

    one year

Secondary Outcomes (1)

  • effect of LiDCO monitoring on cumulative fluid balance

    one year

Study Arms (2)

LI

EXPERIMENTAL

arm controled by LIDCO technology

Device: LiDCO technology

CA

NO INTERVENTION

standard approach

Interventions

LiDCO technologyDEVICE

non invasive monitoring of cardiac output

LI

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age
  • Needs for fluid chalange
  • Invasive ventilatory supportinvasive blood pressure monitoring
  • Lidco monitoring
  • Central venous catheter

You may not qualify if:

  • DNR
  • Need for CRRT
  • Head injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASQA a.s.

Prague, 106 00, Czechia

RECRUITING

Related Publications (5)

  • 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.

    PMID: 9361539BACKGROUND

  • 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.

    PMID: 16155038BACKGROUND

  • 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.

    PMID: 11869649BACKGROUND

  • 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.

    PMID: 14974001BACKGROUND

  • 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.

    PMID: 12190747BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vladimir Cerny, MD, PhD, FCCM

    University Hospital Hradec Kralove

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vladimir Cerny, MD

CONTACT

cernyvla@fnhk.cz

Pavel Valek, MD

CONTACT

+420272761350pavel.valek@asqa.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 21, 2008

First Posted

February 29, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2008

Last Updated

February 29, 2008

Record last verified: 2008-02

Locations

CZ(1)