Trial · NCT01649921
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The primary endpoint is the tumor necrosis factor (TNF)-α secretion by ex vivo lipopolysaccharide (LPS)-stimulated leukocytes as a marker of immunosufficiency/antimicrobial response. | at admission and at days 0, 2, 7, 14 and 28 | |
| Secondary | Outcome of bacterial infection (occurrence of secondary and/or opportunistic infections, duration of antibacterial treatment, microbiological evaluation) | At days 0, 2, 7, 14 and 28 | |
| Secondary | Hemodynamic stability (noradrenalin infusion rate, amount of infused fluids per day, amount of urine produced per day, daily fluid balance) | At days 0, 2, 7, 14 and 28 | |
| Secondary | Mortality (including time to death) at week 2 and week 6 after end of treatment (all causes) | At days 14 and 28 | |
| Secondary | Length of stay at ICU and duration of hospitalization | At days 28 and 56 | |
| Secondary | Organ function | at days 0, 14, and 28 | * Cardiovascular function: lactate level, vasopressor usage, and cardiovascular Sequential Organ Failure Assessment (SOFA) score * Respiratory function: oxygenation index, Pulmonary Arterial Oxygen Tension (PaO2) / fraction of inspired oxygen (FiO2) (P/F) ratio, and respiratory SOFA score * Renal function: creatinine level, urine output, renal replacement therapy usage, and renal SOFA score * Hematologic function: hematologic SOFA score * Hepatic function: Hepatic SOFA score |
| Secondary | Production of other cytokines by leukocytes ex vivo stimulated with various stimuli (including LPS, peptidoglycan, candida) | At admission, at days 0, 2, 7, 14, and 28 | |
| Secondary | Markers of "immune status" (including human leukocyte antigen expression on monocytes (mHLA)-DR and programmed death (PD)-1 expression, interleukin (IL)-6 plasma concentration) | At admission and at days 0, 2, 7, 14, and 28 | |
| Secondary | the correlation between the level of immunoparalysis (indicated by the commonly used marker mHLA-DR and new markers of "immune status" found), and effectiveness of IFN-γ (indicated by TNF-α secretion by ex vivo LPS-stimulated PBMC's). | At days 0, 14, and 28 | |
| Secondary | Transcriptional activity of leukocytes, including microarrays with a focus on inflammatory pathways | At admission and at days 0, 2, 7, 14, and 28 | |
| Secondary | Changes in phenotype or gene expression caused by mechanisms other than changes in the underlying DNA sequence (epigenetic modifications) | At admission and at days 0, 7, and 28 | |
| Secondary | reversibility of monocytes tolerance | Day 0 | the reversibility of monocytes tolerance by the mean of innate immune training (cytokines production such as TNF and Interleukin (IL)-6 will be assessed). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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