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Long-term sequelae after septic multi-organ failure - a pilot study on immunological, neuroendocrine and metabolic changes in post-acute-care hospital

Long-term sequelae after septic multi-organ failure - a pilot study on immunological, neuroendocrine and metabolic changes in post-acute-care hospital

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00004646
Enrollment
24
Registered
2013-01-16
Start date
2013-01-21
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Severe Sepsis Septic shock Chronic critical illness Immunosuppression Healthy volunteer A41 G62.8 G72.8

Interventions

Group 1: Isolation of peripheral T cells and investigation of their functional status: proliferation and activation markers via FACS analysis, signal transduction via biochemical and molecular biologi

Sponsors

Integriertes Forschungs- und Behandlungszentrum Center of Sepsis Control and Care Paul-Martini-Forschergruppe ”Clinical Septomics”
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
55 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Male patients, age 55-80 years 2. State after SIRS / sepsis with multiple organ failure in the pre-treating acute hospital 3. Presence of critical illness polyneuropathy and myopathy (CIPNP and CIMP) 4. Chronic critical illness with 2-organ failure: - Prolonged mechanical ventilation > 3 weeks and < 12 weeks - state after acute renal failure and currently running renal replacement therapy

Exclusion criteria

Exclusion criteria: 1. Previous chemotherapy or radiation therapy 2. C-reactive protein mg> 140 / L 3. Chronic immunosuppression 4. Treatment with Prednisolone within the last 8 days before taking blood samples 5. Current septic inflammation 6. Chronic renal failure with ambulant dialysis 7. Current therapy with vasopressors 8. Acute Lung Injury (ALI): FiO2> 30% 9. Traumatic Brain Injury 10. Intracerebral hemorrhage / stroke within the last 12 weeks

Design outcomes

Primary

MeasureTime frame
Assessment of the functionality of T-cells by means of measuring biochemical and cellbiological parameters of activation: Proliferation / activation markers via FACS analysis Signaltransduction analysis via biochemical assays

Secondary

MeasureTime frame
- Causal link between the results of the immunological studies with metabolically-malnutritiven and neuroendocrine changes in patients - Sepsis history in acute hospital (focus, microbiology, nature, severity and duration of organ failure, surgical interventions) - Polyneuropathy / myopathy - Scores: APACHE II score, NRS 2002 - Duration of mechanical ventilation (days), renal replacement therapy (days), hospital length of stay (days), enteral / parenteral nutrition (kcal / kg / day)

Countries

Germany

Contacts

Public ContactFrank Martin Brunkhorst

Integriertes Forschungs- und Behandlungszentrum Center of Sepsis Control and Care Paul-Martini-Forschergruppe ”Clinical Septomics”

frank.brunkhorst@med.uni-jena.de+49 3641 9323383

Outcome results

None listed

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