Trial registered on ANZCTR


Trial ID
ACTRN12605000060640
Ethics application status
Approved
Date submitted
19/07/2005
Date registered
1/08/2005
Date last updated
11/03/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A trial of G-CSF in septic shock excluding melioidosis.
Scientific title
A single centre double blinded randomised controlled trial of adjunctive granulocyte â¿¿ colony stimulating factor in septic shock (excluding melioidosis) to determine affects on morbidity and mortality.
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Septic shock in adults not caused by melioidosis. 132 0
Condition category
Condition code
Inflammatory and Immune System 151 151 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Granulocyte-colony stimulating factor is a registered drug that is already widely used. The purpose of this study is to establish the efficacy of G-CSF in septic shock. The brand of G-CSF used for this trial is Lenogastrim produced by Merck Sharp and Dome. The participants in this study are randomised to receive either G-CSF (lenogastrim 263 mcg) or placebo (normal saline), intravenously, daily for 10 days. Study drug is discontinued if the participant is discharged from the intensive care unit (ICU) before study day 10.
Intervention code [1] 31 0
Treatment: drugs
Comparator / control treatment
Placebo (normal saline)
Control group
Placebo

Outcomes
Primary outcome [1] 187 0
The primary outcome in this trial is in-hospital mortality.
Timepoint [1] 187 0
The primary outcome is measured at discharge from hospital or at the time of death if the patient dies in hospital.
Secondary outcome [1] 424 0
organ failure
Timepoint [1] 424 0
Measured on a daily basis whilst the patient remains except hospital discharge date which is determined on a case by case basis.
Secondary outcome [2] 425 0
resolution of septic shock,
Timepoint [2] 425 0
Measured on a daily basis whilst the patient remains except hospital discharge date which is determined on a case by case basis.
Secondary outcome [3] 426 0
duration of ventilation and renal replacement therapy
Timepoint [3] 426 0
Measured on a daily basis whilst the patient remains except hospital discharge date which is determined on a case by case basis.
Secondary outcome [4] 427 0
ICU and hospital days
Timepoint [4] 427 0
Measured on a daily basis whilst the patient remains except hospital discharge date which is determined on a case by case basis.
Secondary outcome [5] 428 0
cardiac events and the incidence of adverse events.
Timepoint [5] 428 0
Measured on a daily basis whilst the patient remains except hospital discharge date which is determined on a case by case basis.
Secondary outcome [6] 429 0
Sequential organ failure assessment scores
Timepoint [6] 429 0
Calculated at study baseline and on study days 1,3,7 and 10.

Eligibility
Key inclusion criteria
Participants must fit the ACCP/SCCM Consensus Criteria for septic shock and other more recently agreed-upon non-invasive criteria. These criteria are; at least 2 signs of the presence of infection, cardiovascular failure (shock) and at least 1 sign of organ perfusion abnormality.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Culture confirmed melioidosis, febrile neutropaenia (following chemotherapy), known haematological malignancy, myelodysplasia or congenital neutropaenia, pregnancy, known hypersensitivity to G-CSF, known objection to participate in the trial, previous transplantation, previous participation in this trial, has received G-CSF in the past month, brain death, expected survival of less than 24 hours with active orders limiting treatment and myocardial infarction in the previous 24 hours.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Study drug is prepared by the pharmacist away from ICU. Once prepared G-CSF and placebo look exactly the same. Study drug is prepared 5mls of clear fluid in a 5ml syringe. Each syringe is labeled with participants name and study number Each dose of study drug is delivered to the participants bay by the pharmacist. The syringes are transported from pharmacy to ICU in a sealed plastic box. On delivering study drug to the patients bay the pharmacist confirms participants details. The patients details are then reconfirmed by the nurse administrating the study drug.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation design with equal numbers allocated to each group at predetermined intervals. The random allocation is generated by computer software ie STATA version 7. No restrictions apply.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 203 0
Charities/Societies/Foundations
Name [1] 203 0
A private fund, the Septic Shock Research Fund, supported by the Freemasons
Address [1] 203 0
Freemsons Chapter Darwin Northern Territory
Country [1] 203 0
Australia
Primary sponsor type
Hospital
Name
Intensive care unit, Royal Darwin Hospital
Address
Royal Darwin Hospital
Rocklands Drive
Tiwi NT 0811
Country
Australia
Secondary sponsor category [1] 152 0
None
Name [1] 152 0
N/A
Address [1] 152 0
Country [1] 152 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 966 0
Human Research Ethics Committee of the Northern Territory Department of Health and Community Services
Ethics committee address [1] 966 0
Ethics committee country [1] 966 0
Australia
Date submitted for ethics approval [1] 966 0
Approval date [1] 966 0
Ethics approval number [1] 966 0
Ethics committee name [2] 967 0
Menzies School of Health Research
Ethics committee address [2] 967 0
Ethics committee country [2] 967 0
Australia
Date submitted for ethics approval [2] 967 0
Approval date [2] 967 0
Ethics approval number [2] 967 0
Ethics committee name [3] 968 0
Flinders Clinical Research Ethics Committee
Ethics committee address [3] 968 0
Ethics committee country [3] 968 0
Australia
Date submitted for ethics approval [3] 968 0
Approval date [3] 968 0
Ethics approval number [3] 968 0
Ethics committee name [4] 969 0
Flinders Medical Centre South Australia
Ethics committee address [4] 969 0
Ethics committee country [4] 969 0
Australia
Date submitted for ethics approval [4] 969 0
Approval date [4] 969 0
Ethics approval number [4] 969 0

Summary
Brief summary
The purpose of this study is to determine whether the use of adjunctive G-CSF therapy decreases mortality and morbidity in critically ill patients with septic shock. Patients are screened for eligibility to participate in the study. If all inclusion criteria are met and there are no exclusion criteria consent is obtained from the patients or next of kin. Once consent is obtained the ICU pharmacist is contacted and the patient is randomised to receive either G-CSF or placebo once a day for 10 days or until discharge from ICU if that is sooner.
Data is collected on a daily basis whilst the patient is in ICU and following discharge from ICU the date of hospital discharge or death is obtained from the hospital patient records database.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35304 0
Address 35304 0
Country 35304 0
Phone 35304 0
Fax 35304 0
Email 35304 0
Contact person for public queries
Name 9220 0
Dr. Dianne Stephens
Address 9220 0
Department of Intensive Care
Royal Darwin Hospital
Rocklands Drive
Tiwi NT 0811
Country 9220 0
Australia
Phone 9220 0
+61 8 89228711
Fax 9220 0
+61 8 89228733
Email 9220 0
dianne.stephens@nt.gov.au
Contact person for scientific queries
Name 148 0
Dr. Dianne Stephens
Address 148 0
Department of Intensive Care
Royal Darwin Hospital
Rocklands Drive
Tiwi NT 0811
Country 148 0
Australia
Phone 148 0
+61 8 89228711
Fax 148 0
+61 8 89228733
Email 148 0
dianne.stephens@nt.gov.au