In vivo analysis of the 11-beta-hydroxysteroid dehydrogenase activity during critical illness using isotopically labeled cortisol and cortisone

In vivo analysis of the 11-beta-hydroxysteroid dehydrogenase activity during acute and prolonged critical illness using isotopically labeled cortisol and cortisone: an observational study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN08083905

Enrollment

Registered

2009-11-23

Start date

2012-02-13

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical illness Not Applicable

Interventions

Current interventions as of 15/02/2012 After admission to the SICU, patients will be evaluated on their appropriateness for the study and written informed consent will be obtained from the patient or

blood samples are taken at t = -5, +60, +120, +160, +165, +170, +175 min. - 1,2-D2-cortisone as a bolus of 0.076 mg at t = +100 followed by infusion of 0.1053 mg/hour

an additional blood sample is taken at t = -5 min, +120min,+140 min. - urine samples are collected at t =0, +60, +120, +180. - A complete 24h urine collection will be collected started at the moment

for collection of the urine samples they will be asked to urinate at the appropriate time points. Previous interventions After admission to the SICU, patients will be evaluated on their appropriaten

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 15/02/2012 For patients: 1. Admitted to the surgical intensive care unit (SICU) of the Leuven University Hospital 2. No age limits, either sex For healthy control persons: 1. Age- and gender-matched to the included patients Previous inclusion criteria For patients: 1. Admitted to the surgical intensive care unit (SICU) of the Leuven University Hospital 2. Estimated duration of illness prior to admission less than 48 hours 3. No age limits, either sex For healthy control persons: 1. Age- and gender-matched to the included patients

Exclusion criteria

Exclusion criteria: Steroids received during the last 3 months

Design outcomes

Primary

Measure	Time frame
Current primary outcome(s) as of 15/02/2012 An estimation of the amount of ACTH-driven cortisol production , the amount of cortisol regenerated from cortisone via 11-beta-HSD1and 2 and the activity of the different metabolizing enzymes based on urinary metabolites. Previous primary outcome(s) An estimation of the amount of ACTH-driven cortisol production and the amount of cortisol regenerated from cortisone via 11-beta-HSD1, measured at day 2 and 7 after admission.	—

Measure

Time frame

Current primary outcome(s) as of 15/02/2012 An estimation of the amount of ACTH-driven cortisol production , the amount of cortisol regenerated from cortisone via 11-beta-HSD1and 2 and the activity of the different metabolizing enzymes based on urinary metabolites. Previous primary outcome(s) An estimation of the amount of ACTH-driven cortisol production and the amount of cortisol regenerated from cortisone via 11-beta-HSD1, measured at day 2 and 7 after admission.

—

Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

Belgium

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 24, 2026