Trial · NCT01649921
The Effects of Interferon-gamma on Sepsis-induced Immunoparalysis
NCT01649921, Phase 3, Completed, Radboud University Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effects of Interferon-gamma on Sepsis-induced Immunoparalysis. Trials, record NCT01649921. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01649921
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effects of Interferon-gamma on Sepsis-induced Immunoparalysis
- NCT number
- NCT01649921
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4 participants, actual
- Lead sponsor
- Radboud University Medical Center
- Conditions
- Sepsis, Septic Shock
- Interventions
- Interferon-gamma, Recombinant, Saline 0.9%
- First posted
- 2012-07-25
- Last updated
- 2017-09-29
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01649921
GET https://conductscience.org/api/trials/v1/NCT01649921/registered