NCT01283529

Brief Summary

Pulse induced continuous cardiac output (PiCCO) is an established technology for measurement of advanced hemodynamic variables in critically ill patients. PiCCO is approved and designed also for use in children, but there is a lack of documentation of reference values in children not suffering from a critical illness. The goal of this study is to establish such values.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 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

January 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

3.1 years

First QC Date

January 17, 2011

Last Update Submit

August 29, 2016

Conditions

Reference Values

Keywords

Intrathoracal blood volumeCardiac outputChildren

Outcome Measures

Primary Outcomes (1)

  • Reference values for PiCCO variables

    18 months

Study Arms (1)

Children 0 - 15 years

Children undergoing neurosurgery in general anesthesia

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

40 children age 0 - 15 years undergoing major neurosurgery under general anesthesia

You may qualify if:

  • Age \< 15 years
  • Scheduled for major neurosurgery in general anesthesia

You may not qualify if:

  • Cardiac disease
  • Infection / sepsis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital, Rikshospitalet

Oslo, Oslo County, 0871, Norway

Location

Study Officials

  • Gunnar Bentsen, MD PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

January 17, 2011

First Posted

January 26, 2011

Study Start

January 1, 2011

Primary Completion

February 1, 2014

Study Completion

September 1, 2015

Last Updated

August 30, 2016

Record last verified: 2016-08

Locations

NO(1)