Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000001291
Ethics application status
Approved
Date submitted
27/11/2008
Date registered
6/01/2009
Date last updated
6/01/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of new remedy IMOD [Immunomodulating drug ] on the mortality of patients with severe sepsis. A phase III multicenter study
Scientific title
Effect of new remedy drug IMOD[Immunomodulating drug] on the mortality of patients with severe sepsis. A phase III multicenter study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sepsis 4034 0
Condition category
Condition code
Inflammatory and Immune System 4237 4237 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
treatment with 10 cc IMOD(intravenous) for 2 weeks plus standard treatment of sepsis.
standard treatment include:1.Early goal - directed resuscitation
2.Appropriate diagnostic studies prior to antibiotics
3.Early broad – spectrum antibiotics
4.Narrowing antibiotic therapy based on microbial therapy and clinical data
5.Source control
6.Stress dose steroids for septic shock
7.Target Hemoglubin values of 7-9 gr/dlit in absence of coronary artery disease or acute hemorrhage
8.Lung protective ventilation for Acute Lung Injury/Acute respiratory Distress Syndrome
9.Avoidance of Neuromuscular blockade
10.Maintenance of blood glucose < 150mg/dlit
11.Deep Vein Prophylaxy/stree ulcer prophylaxis
Intervention code [1] 3756 0
Treatment: Drugs
Comparator / control treatment
placebo plus standard treatment of sepsis for 2 weeks(ampuls with normal saline in volume of 10cc) which is injected intravenously
Control group
Placebo

Outcomes
Primary outcome [1] 5125 0
mortality at 28 days
Timepoint [1] 5125 0
28 days
Secondary outcome [1] 8628 0
morbidity(Length of stay, SOFA [Sepsis-related Organ failure Assessment])
Timepoint [1] 8628 0
90 days

Eligibility
Key inclusion criteria
Severe sepsis with APACHE (Acute Physiology And Chronic Health Evaluation)Score>20 with less than 24 hours after their diagnosis.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
pregnant or lactating person, Age less than 16 years old, high death possibility within 24-48 hours and previous organ transplantation and receiving immunosuppressant drugs.

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)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 1419 0
Iran, Islamic Republic Of
State/province [1] 1419 0

Funding & Sponsors
Funding source category [1] 4214 0
University
Name [1] 4214 0
tehran university of medical sciences
Country [1] 4214 0
Iran, Islamic Republic Of
Primary sponsor type
Commercial sector/Industry
Name
pars rus
Address
13rd alley, Hormozan street, Shahrak-e-gharb
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 3788 0
University
Name [1] 3788 0
Tehran University of Medical Sciences
Address [1] 3788 0
Engelab street,Tehran
Country [1] 3788 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6266 0
Pharmaceutical sciences research center
Ethics committee address [1] 6266 0
Tehran University of Medical Sciences,Engelab street,Tehran
Ethics committee country [1] 6266 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 6266 0
04/05/2008
Approval date [1] 6266 0
14/09/2008
Ethics approval number [1] 6266 0
425/765

Summary
Brief summary
Patients in IMOD group received IMOD in addition to standard treatment. They received 5 IMOD in 100cc DW 5% which is infused over 1 hour on the first day. All hemodynamic data were noted during the time of infusion in order to stop the infusion in the case of any negative hemodynamic deterioration, dermal rash, urticaria and anaphylactic reaction. Then 10cc IMOD in 100cc DW 5% was infused everyday until day 14 of the treatment protocol. the time gap between the beginning of treatment with IMOD and the diagnosis of sepsis was also noted to evaluate possible impact of the onset time of IMOD on mortality . The control group have received the standard treatment for sepsis including:.Early goal – directed resuscitation, appropriate diagnostic studies prior to antibiotics, early broad – spectrum antibiotics ,narrowing antibiotic therapy based on microbial therapy and clinical data source control ,stress dose steroids for septic shock, target Hb values of 7-9 gr/dlit in absence of coronary artery disease or acute hemorrhage, lung protective ventilation for Acute Lung Injury/Acute Respiratory Distress Syndrome, avoidance of Neuromuscular blockade, maintenance of blood glucose < 150mg/dl and Deep Vein Thrombosis/stress ulcer prophylaxis. Inflammatory biomarkers including IL1, IL2, IL6, Tumor Necrosis Factor a ,Plasminogen Activator Inhibitor, Nitric Oxide, Total antioxidant power that were assessed on days 0, 1, 2, 3, 7, 10, 14 throughout the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29171 0
Address 29171 0
Country 29171 0
Phone 29171 0
Fax 29171 0
Email 29171 0
Contact person for public queries
Name 12328 0
Ata Mahmoodpoor
Address 12328 0
General ICU, Shohada Hospital, Tabriz
Country 12328 0
Iran, Islamic Republic Of
Phone 12328 0
+989141160888
Fax 12328 0
Email 12328 0
[email protected]
Contact person for scientific queries
Name 3256 0
Ata Mahmoodpoor
Address 3256 0
General ICU, Shohada Hospital, Tabriz
Country 3256 0
Iran, Islamic Republic Of
Phone 3256 0
+989141160888
Fax 3256 0
Email 3256 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.