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 Childrens 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
Funders
Funder type
Hospital/treatment centre
Funder name
Erasmus Medical Centre, Sophia Childrens 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