Condition category
Infections and Infestations
Date applied
22/06/2010
Date assigned
07/07/2010
Last edited
07/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Koen Joosten

ORCID ID

Contact details

Dr Molewaterplein 60
Rotterdam
3000CB
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

196429 / 2000 / 222

Study information

Scientific title

Pathophysiological aspects of hyperglycemia in children with meningococcal sepsis and septic shock: a prospective, observational cohort study

Acronym

Study hypothesis

The objective of the present study was to investigate the occurrence of hyperglycemia in relation with the insulin response and exogenous factors, such as glucose intake and drug use, in a homogenous group of critically ill children with meningococcal sepsis and/or meningococcal septic shock.

Ethics approval

The Medical Ethics Committee (MEC) approved in March 2000 (ref: 196429 / 2000 / 222)

Study design

Prospective observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

Meningococcal sepsis

Intervention

Observational cohort study. Blood samples to be taken on admission, and at 24 and 48 hours thereafter.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Blood glucose levels
2. Plasma levels of
2.1. insulin
2.2. C-peptide
2.3. cortisol
2.4. cytokines
2.5. C-reactive protein (CRP)
2.6. cytokines
Measured on admission, and at 24 and 48 hours.

Secondary outcome measures

None

Overall trial start date

01/10/1997

Overall trial end date

01/05/2004

Reason abandoned

Eligibility

Participant inclusion criteria

The study population consisted of previously healthy children admitted to the Pediatric Intensive Care Unit (PICU) of the Erasmus Medical Centre - Sophia Children’s Hospital between October 1997 and May 2004, suffering from meningococcal sepsis, i.e. sepsis with petechiae/purpura

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Pre-existing endocrine or chromosomal abnormalities
2. Radiation or chemotherapy within the previous 6 months

Recruitment start date

01/10/1997

Recruitment end date

01/05/2004

Locations

Countries of recruitment

Netherlands

Trial participating centre

Dr Molewaterplein 60
Rotterdam
3000CB
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre, Sophia Children’s Hospital (Netherlands)

Sponsor details

Dr Molewaterplein 60
Rotterdam
3000CB
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Erasmus Medical Centre, Sophia Children’s Hospital (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes