Time course of hypothalamic-pituitary adrenal alterations in response to critical illness

On the dynamics of the hypothalamus-pituitary-adrenal axis response to prolonged critical illness: a prospective observational study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN98806770

Enrollment

562

Registered

2014-12-30

Start date

2014-12-01

Completion date

Unknown

Last updated

2018-12-04

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

To evaluate the evolution of the HPA-axis alterations during critical illness, 24h-urine collection samples and blood samples (4 ml) will be collected daily in critically ill patients from day 7 until

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: For patients: 1. Critically ill patients admitted for =7 days to one of the five ICUs from two departments (medical and surgical) in the University Hospitals Leuven 2. Age =18 years For healthy volunteers: 1. Age-, gender- and BMI-matched to the included patients

Exclusion criteria

Exclusion criteria: For patients: 1. Predisposing factors of adrenal insufficiency: 1.1. Cerebral disease with intracranial hypertension threatening the neuroendocrine system 1.2. Pituitary disorders including (pan)hypopituitarism 1.3. Known adrenal disease (Cushing's syndrome or Addison's disease) 1.4. Treatment with glucocorticoids, other steroids or anti-steroid chemotherapy within the last 3 months 1.5. Use of etomidate within the last 72 hours 1.6. Other drugs predisposing to adrenal insufficiency: azoles, phenytoin, rifampicin, glitazones, imipramin, phenothiazine, phenobarbital 2. No arterial line in place 3. Ethical restrictions: 3.1. Moribund 3.2. Declined participation For healthy volunteers: 1. Recent history of treatment with HPA-axis interfering drugs

Design outcomes

Primary

Measure	Time frame
1. Determination of the evolution of ACTH and cortisol plasma concentrations and urine cortisol metabolites during prolonged critical illness and upon recovery, in comparison with ACTH and cortisol plasma concentrations of healthy volunteers. 2. To characterize the time course of the response to exogenous ACTH during prolonged critical illness and upon recovery, in comparison with response to exogenous ACTH in healthy volunteers.	—

Measure

Time frame

1. Determination of the evolution of ACTH and cortisol plasma concentrations and urine cortisol metabolites during prolonged critical illness and upon recovery, in comparison with ACTH and cortisol plasma concentrations of healthy volunteers. 2. To characterize the time course of the response to exogenous ACTH during prolonged critical illness and upon recovery, in comparison with response to exogenous ACTH in healthy volunteers.

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Secondary

Measure	Time frame
Further mechanistic analyses using clinical and laboratory parameters.	—

Countries

Belgium

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026