Echocardiography in Kids Intensive Care Decision Support | NCT01821742

Studies
Echocardiography in Kids Intensive Care Decision Support

NCT01821742

Sponsor

Imperial College London

Status

Completed

Last Update Posted

Jul 8, 2019Actual

Enrollment

25Actual

Phase

Not provided

Conditions

Fluid Responsiveness
Cardiac Output

Interventions

Ultrasound cardiac output measurement

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013Actual

Primary Completion Date

Jul 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Mar 22, 2013

First Submission Date that Met QC Criteria

Mar 29, 2013

First Posted Date

Apr 1, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2019

Last Update Posted Date

Jul 8, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

A study to determine if echocardiographically derived parameters, plethysmographic variability index and pulse pressure variation predict fluid responsiveness in children on PICU. These parameters will be measured pre and post fluid bolus in children prescribed fluid bolus therapy for clinical indications on the PICU. Children will be classified as responders (>10% increase in cardiac output) and non responders (<10% increase). Appropriate statistical tests will be performed to determine the most useful predictor of an increase in cardiac output following a fluid bolus.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Children requiring fluid bolus on PICU			Other: Ultrasound cardiac output measurement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound cardiac output measurement	Other		Children requiring fluid bolus on PICU

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fluid responsiveness	10% increase in cardiac output following fluid bolus	Immediate

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Arrythmia
Intracardiac shunt

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

16 Years

Standard Ages

Child

Study Population

Shocked children on PICU

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Inwald, MB BChir	Imperial College London	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Imperial College Healthcare NHS Trust		London		W2 1NY	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24306083	Result	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.

Type	Date	Date Unknown
Release	Apr 11, 2024
Reset	Sep 12, 2024
Release	Sep 16, 2024
Reset	Nov 15, 2024
Release	Jan 9, 2025
Unrelease	Jan 13, 2025
Release	Jan 14, 2025
Reset	Jan 14, 2025

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 11, 2024			Sep 12, 2024
Sep 16, 2024

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms