Dynamics of endocrine and inflammatory changes during critical illness

Completed

• Conditions: Critical illness; Not Applicable

• Registration Number: ISRCTN49306926
• Lead Sponsor: IWT Flanders (Agentschap voor Innovatie door Wetenschap en Techniek) (Belgium)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-12
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

Intervention 1:
1. Patients: all patients admitted to the surgical and medical intensive care units of the university hospitals, Leuven, (Belgium), will be screened for inclusion when they are still mechanically ventilated at the 2nd, 3rd or 4th day after admission, provided that they do not meet one of the exclusion criteria below.
2. Healthy volunteers: Age-matched to the average age of the included patient population

Added 25/10/2011:
Intervention 2:
1. Patients: all patients with a urinary catheter, present at the surgical and medical intensive care units of the university hospitals, Leuven (Belgium).
2. Healthy volunteers: age-matched to the average age of the included patient population.

Intervention 3:
1. Patients: critically ill patients who died in the intensive care unit and who undergo an autopsy.
2. Controls: non-critically ill persons who died in the emergency unit and who undergo an autopsy.

Intervention 4:
1. Patients: patients receiving a bolus injection of hydrocortisone based on clinical indications.
2. Healthy volunteers: age matched to the average age of the included patient population.

Exclusion Criteria

Intervention 1 and 2:
1. Patients:
1.1. Age < 18 years
1.2. Do not resuscitate order
1.3. No arterial line in place
1.4. Patients expected to die within the next 24 hours
1.5. Pregnancy
1.6. Cerebral disease
1.7. (pan)Hypopituitarism
1.8. Known adrenal disease (Cushing or Addisson)
1.9. Systemic treatment with corticosteroids within the last 3 months
1.10. Etomidate within the last 72 hours
1.11. Dopamine within the last 12 hours
1.12. Vasopressine within the last 12 hours
1.13. Treatment with an azole within the last 24 hours
2. Healthy volunteers:
2.1. Age <50 or >75 years
2.2. Active malignancy
2.3. Pregnancy
2.4. Cerebral disease
2.5. (pan)Hypopituitarism
2.6. Known adrenal disease (Cushing or Addisson)
2.7. Systemic treatment with corticosteroids within the last 3 months

Added 25/10/2011:
Intervention 3:
1. Patients:
1.1. Age < 18 years
1.2. Cerebral disease
1.3. (pan)hypopituitarism
1.4. Known adrenal disease (Cushing or Addisson)
1.5. Systemic treatment with corticosteroids within the last 3 months before death
2. Controls
2.1. Critical illness or chronic disease
2.2. Cerebral disease
2.3. Systemic treatment with corticosteroids within the last 3 months before death

Intervention 4:
1. Patients:
1.1. Age < 18 years
1.2. No arterial line in place
1.3. Ascites
2. Healthy volunteers:
Same as for intervention 1

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Comparison between the secretion dynamics of cortisol and ACTH, and comparison with time series of inflammatory markers, will allow us to identify the main driving mechanisms for cortisol production during critical illness.<br><br>Added 25/10/2011:<br><br>2. Comparison of the ratios of urinary cortisol metabolites will allow us to detect a difference in activity of the cortisol metabolizing enzymes between critically ill patients and healthy control persons.<br>3. We will study adrenal morphology and storage of lipid droplets, to detect the effect of critical illness associated endocrine changes on the adrenals.<br>4. Knowing the plasma half-live of cortisol during critical illness will allow us to gain correct deconvolution data.