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| Name | Class |
|---|---|
| The Swedish Research Council | OTHER_GOV |
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This is a study of plasma HBP -levels of a previously published trial of G-CSF in critically ill patients (Pettila et al. Critical Care Medicine 2000). The original study was a prospective, randomised, double-blind, placebo-controlled trial of filgrastim in patients with acute respiratory failure requiring intubation. In this substudy, the investigators evaluated the effect of filgrastim on HBP -concentrations in critically ill patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Filgrastim | Active Comparator | Filgrastim 300 microgr/day subcutaneously for 7 days |
|
| NaCl 0.9% | Placebo Comparator | Corresponding placebo once daily, subcutaneously for 7 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filgrastim | Drug | Filgrastim 300 ug daily for 7 days, subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | the number of patients developing ARDS, disseminated intravascular coagulation or acute renal failure during days 1-28, and changes in MOD score during days 1-7. | up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| follow up measures | frequency of nosocomial infections, length of mechanical ventilatory support, length of stay in the ICU, 28-day mortality rate, 90-day mortality rate, and laboratory values for neutrophil count | Up to day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| inflammatory mediators | cytokines, IL-6, TNF, phospolipase A2 and BPIP (=bacterial permeability increasing protein) | up to day 7 |
Criteria for original study. For the substudy, all these patients were included.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ville Pettila, MD, PhD | Helsinki University Central Hospital | Study Director |
| Kirsi-Maija Kaukonen, MD, PhD | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Central Hospital | Helsinki | 00029 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11098963 | Result | Pettila V, Takkunen O, Varpula T, Markkola A, Porkka K, Valtonen V. Safety of granulocyte colony-stimulating factor (filgrastim) in intubated patients in the intensive care unit: interim analysis of a prospective, placebo-controlled, double-blind study. Crit Care Med. 2000 Nov;28(11):3620-5. doi: 10.1097/00003246-200011000-00011. | |
| 15883741 |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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| Takala A, Pettila V, Takkunen O, Rintala E, Kautiainen H, Repo H. Granulocyte colony-stimulating factor therapy and systemic inflammation in critically ill patients. Inflamm Res. 2005 Apr;54(4):180-5. doi: 10.1007/s00011-005-1340-2. |
| 23363492 | Derived | Kaukonen KM, Herwald H, Lindbom L, Pettila V. Heparin binding protein in patients with acute respiratory failure treated with granulocyte colony-stimulating factor (filgrastim)--a prospective, placebo-controlled, double-blind study. BMC Infect Dis. 2013 Jan 30;13:51. doi: 10.1186/1471-2334-13-51. |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |