Dynamics of the stress response in acute and prolonged critical illness

The dynamics of the ACTH and cortisol response to CRH stimulation during critical illness: a randomized, double-blind, placebo-controlled crossover study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14587520

Enrollment

Registered

2016-07-07

Start date

2016-08-30

Completion date

Unknown

Last updated

2022-09-05

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

The trialists will study unique patients from different time cohorts, with an increasing duration of critical illness, in order to have three sets of patients who represent three different time points

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: For patients: 1. Critically ill patients at the surgical or medical intensive care units, with ongoing intensive care dependency, a stable condition for at least 48h, and an expected stay in ICU for at least 48h 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. Chronic treatment with glucocorticoids, other steroids or anti-steroid chemotherapy within the last 3 months 1.5. IV administration of glucocorticoids within the last 72 hours 1.6. Use of etomidate within the last 72 hours 1.7. Use of azoles within the last 7 days 1.8. Other drugs predisposing to adrenal insufficiency: phenytoin, rifampicin, glitazones, imipramin, phenothiazine, phenobarbital 2. Patients known to be pregnant or nursing 3. No arterial line or central venous catheter in place 4. Ethical restrictions 4.1. Moribund 4.2. Declined participation For healthy volunteers: 1. Recent history of treatment with HPA-axis interfering drugs

Design outcomes

Primary

Measure	Time frame
ACTH and cortisol responses to exogenous CRH/placebo in relation with available baseline demographic and clinical outcome data, collected during ICU stay. Quantification of plasma ACTH and cortisol will be done during 2 consecutive mornings from 10.45-13.00h, after receiving an alternate injection of CRH or placebo each morning, in the acute phase (ICU day 3-6), the intermediate phase (ICU day 7-16) and prolonged phase (ICU day 17-28) of critical illness.	—

Measure

Time frame

ACTH and cortisol responses to exogenous CRH/placebo in relation with available baseline demographic and clinical outcome data, collected during ICU stay. Quantification of plasma ACTH and cortisol will be done during 2 consecutive mornings from 10.45-13.00h, after receiving an alternate injection of CRH or placebo each morning, in the acute phase (ICU day 3-6), the intermediate phase (ICU day 7-16) and prolonged phase (ICU day 17-28) of critical illness.

—

Secondary

Measure	Time frame
Secondary endpoints (clinical parameters and treatment information) will be collected during their stay in ICU	—

Countries

Belgium

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026