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Dynamics of endocrine and inflammatory changes during critical illness

Dynamics of endocrine and inflammatory changes during critical illness: An observational trial comparing patients and healthy volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN49306926
Enrollment
133
Registered
2010-08-12
Start date
2010-08-09
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

1. At the second day after admission to the ICU, patients will be evaluated on their appropriateness for the study and written informed consent will be obtained from the closest family member or legal

Sponsors

IWT Flanders (Agentschap voor Innovatie door Wetenschap en Techniek) (Belgium)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Intervention 1 and 2: 1. Patients: 1.1. Age 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

Design outcomes

Primary

MeasureTime frame
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. Added 25/10/2011: 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. 3. We will study adrenal morphology and storage of lipid droplets, to detect the effect of critical illness associated endocrine changes on the adrenals. 4. Knowing the plasma half-live of cortisol during critical illness will allow us to gain correct deconvolution data.

Countries

Belgium

Outcome results

None listed

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