Pathophysiological aspects of hyperglycemia in children with meningococcal sepsis and septic shock
| ISRCTN | ISRCTN68283215 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68283215 |
| Secondary identifying numbers | 196429 / 2000 / 222 |
- Submission date
- 22/06/2010
- Registration date
- 07/07/2010
- Last edited
- 07/07/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Koen Joosten
Scientific
Scientific
Dr Molewaterplein 60
Rotterdam
3000CB
Netherlands
Study information
| Study design | Prospective observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| Scientific title | Pathophysiological aspects of hyperglycemia in children with meningococcal sepsis and septic shock: a prospective, observational cohort study |
| Study objectives | 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(s) | The Medical Ethics Committee (MEC) approved in March 2000 (ref: 196429 / 2000 / 222) |
| Health condition(s) or problem(s) studied | Meningococcal sepsis |
| Intervention | Observational cohort study. Blood samples to be taken on admission, and at 24 and 48 hours thereafter. |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/10/1997 |
| Completion date | 01/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 80 |
| Key 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 |
| Key exclusion criteria | 1. Pre-existing endocrine or chromosomal abnormalities 2. Radiation or chemotherapy within the previous 6 months |
| Date of first enrolment | 01/10/1997 |
| Date of final enrolment | 01/05/2004 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Dr Molewaterplein 60
Rotterdam
3000CB
Netherlands
3000CB
Netherlands
Sponsor information
Erasmus Medical Centre, Sophia Childrens Hospital (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Dr Molewaterplein 60
Rotterdam
3000CB
Netherlands
"ROR" |
https://ror.org/047afsm11 |
|---|
Funders
Funder type
Hospital/treatment centre
Erasmus Medical Centre, Sophia Childrens Hospital (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
