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Randomized, double-blind, placebo-controlled trial of granulocyte colony-stimulating factor in patients with septic shock

Stephens, D., Thomas, J., Higgins, L., Bailey, M., Anstey, Nicholas M., Currie, Bart J. and Cheng, Allen C. (2008). Randomized, double-blind, placebo-controlled trial of granulocyte colony-stimulating factor in patients with septic shock. Critical Care Medicine,36(2):448-454.

Document type: Journal Article

IRMA ID 10002xPUB47
Title Randomized, double-blind, placebo-controlled trial of granulocyte colony-stimulating factor in patients with septic shock
Author Stephens, D.
Thomas, J.
Higgins, L.
Bailey, M.
Anstey, Nicholas M.
Currie, Bart J.
Cheng, Allen C.
Journal Name Critical Care Medicine
Publication Date 2008
Volume Number 36
Issue Number 2
ISSN 0090-3493   (check CDU catalogue open catalogue search in new window)
Start Page 448
End Page 454
Total Pages 7
Place of Publication US
Publisher Lippincott Williams & Wilkins
Field of Research 1110 - Nursing
1103 - Clinical Sciences
HERDC Category C1 - Journal Article (DEST)
Abstract Objective: To investigate the effect of early administration of granulocyte colony-stimulating factor (G-CSF) on hospital mortality in nonneutropenic patients with septic shock, excluding patients with melioidosis.

Design: A randomized, placebo-controlled, double-blinded clinical trial.

Setting and Patients: Adult patients with septic shock admitted to the Royal Darwin Hospital Intensive Care Unit.

Interventions: Patients were randomized to receive G-CSF or placebo intravenously daily for 10 days, in addition to routine management of septic shock.

Measurements: Primary outcome was hospital mortality. Secondary outcomes included intensive care unit mortality, intensive care unit and hospital length of stay, ventilator hours, and time to resolution of shock. Patient comorbidities, baseline and daily physiology, and organ function were collected.

Results: Of 166 patients enrolled, 83 were allocated to receive G-CSF (81 included in analysis) and 83 were allocated to receive placebo. At baseline, 30% of patients had diabetes, 18% were known to have renal impairment or failure, and 38% had a history of hazardous alcohol use. The two groups had similar comorbidities at baseline and a similar severity of illness. The in-hospital mortality was 27% in the G-CSF group and 25% in the placebo group. Secondary end points were not different between groups. There was a higher rate of new organ failure in G-CSF-treated patients than placebo-treated patients (50% vs. 33%, p = .03), most of which was accounted for by new liver dysfunction (11% vs. 1%, p = .007). There was no significant difference in the proportion of patients with troponin I of >0.08 mg/L (78% vs. 66%, p = .09), and the prevalence of acute myocardial infarction (6% vs. 4%, p = .55) was not different during the study. The median peak troponin I level was higher in the G-CSF group (0.5 vs. 0.14 mg/L, p = .007), but baseline levels were not available.

Conclusion: G-CSF does not improve outcomes in patients with septic shock, excluding melioidosis. Increased hepatic dysfunction and higher peak troponin levels in patients receiving G-CSF have not been reported in previous clinical trials and warrant further investigation.
DOI http://dx.doi.org/10.1097/01.CCM.0B013E318161E480   (check subscription with CDU E-Gateway service for CDU Staff and Students  check subscription with CDU E-Gateway in new window)
 
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