Trial · NCT01653665
Does GM-CSF Restore Neutrophil Phagocytosis in Critical Illness?
NCT01653665, Phase 1, Phase 2, Completed, Newcastle-upon-Tyne Hospitals NHS Trust
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Does GM-CSF Restore Neutrophil Phagocytosis in Critical Illness? Trials, record NCT01653665. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01653665
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Does GM-CSF Restore Neutrophil Phagocytosis in Critical Illness?
- NCT number
- NCT01653665
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 64 participants, actual
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Conditions
- Critical Illness, Sepsis, Immuno-suppression
- Interventions
- Leukine, Normal Saline
- First posted
- 2012-07-31
- Last updated
- 2018-02-13
- Other registries' IDs
- eudract:2011-005815-10, isrctn:ISRCTN95325384
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Neutrophil phagocytosis | 2 days after GMCSF/placebo administration | neutrophil phagocytic capacity will be measured as the percentage of neutrophils ingesting 2 or more zymosan particles ex vivo |
| Secondary | neutrophil phagocytic capacity on alternate study days | 0 - 9 days | Measured on alternate days and also as 'area under the curve' over the study period |
| Secondary | Other measures of neutrophil function | 0-9 days | May include but not limited to: ROS generation, migration capacity and apoptotic rate |
| Secondary | Monocyte HLA-DR expression | 0-9 days | Alternate days by flow-cytometry |
| Secondary | Serum measures of inflammatory response | 0-9 days | May include but not limited to: cytokine levels |
| Secondary | Sequential organ failure assessment (SOFA) | up to end of study participation, a maximum of 30 days for each participant | |
| Secondary | Length of ICU stay | Up to end of participation in study, a maximum of 30 days | |
| Secondary | Incidence of ICUAIs (Intensive care unit acquired infection) | Up to end of study participation, a maximum of 30 days for each patients | As defined by hospitals in europe link for infection control surveillance (HELICS) |
| Secondary | All cause mortality | 30 days post randomisation | |
| Secondary | Number of days of mechanical ventilation | Up to end of study participation, a maximum of 30 days |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 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/NCT01653665
GET https://conductscience.org/api/trials/v1/NCT01653665/registered