NCT01821742

Brief Summary

A study to determine if echocardiographically derived parameters, plethysmographic variability index and pulse pressure variation predict fluid responsiveness in children on PICU.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

4 months

First QC Date

March 22, 2013

Last Update Submit

July 3, 2019

Conditions

Fluid ResponsivenessCardiac Output

Keywords

ShockFluid bolusCardiac outputChildren in intensive care

Outcome Measures

Primary Outcomes (1)

  • Fluid responsiveness

    10% increase in cardiac output following fluid bolus

    Immediate

Study Arms (1)

Children requiring fluid bolus on PICU

Other: Ultrasound cardiac output measurement

Interventions

Ultrasound cardiac output measurementOTHER
Children requiring fluid bolus on PICU

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Shocked children on PICU

You may qualify if:

  • Any ventilated child requiring fluid bolus therapy on the PICU for clinical indications

You may not qualify if:

  • Arrythmia
  • Intracardiac shunt

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

Related Publications (1)

  • McLean JRL, Inwald DP. The utility of stroke volume variability as a predictor of fluid responsiveness in critically ill children: a pilot study. Intensive Care Med. 2014 Feb;40(2):288-289. doi: 10.1007/s00134-013-3171-x. Epub 2013 Dec 5. No abstract available.

    PMID: 24306083RESULT

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David Inwald, MB BChir

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2013

First Posted

April 1, 2013

Study Start

March 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 8, 2019

Record last verified: 2019-07

Locations

GB(1)