Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000376448
Ethics application status
Approved
Date submitted
10/06/2007
Date registered
16/07/2007
Date last updated
16/07/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effect of new remedy IMOD (Imunomodulating Drug)in the treatment of adult patients with sever sepsis
Scientific title
Evaluating the effect of new remedy IMOD(Imunomodulating Drug) on the mortality of adult patients with sever sepsis in Sina Hospital
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe sepsis 1956 0
Condition category
Condition code
Blood 2053 2053 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group received mentioned treatments plus (Imunomodulating Drug)IMOD (only 10 mililitre/day infusion once over 1 hour for 14 days) IMOD is a new remedy drug which increases CD4 lymphocytes significantly in patients with AIDS. IMOD has strong anti-inflammatory effects and induces immune system without any significant side effects.Patients recieved standard treatment for the time needed,for example DVT prophylaxy upto time the patientis is immobilized or lung protective strategies until patints needmechanical ventilatory support.
Intervention code [1] 1818 0
Treatment: Drugs
Comparator / control treatment
Control group receives the following treatments: 1.early goal directed resuscitation 2.appropriate diagnostic study 3.early broad spectrum antibiotics 4.narrowing antibiotics based on clinical and microbial data 5.stress dose steroid for septic shock 6.target Hg(Hemoglubine) value of 7-9 g/dl(gram/decilitre) in absence of CAD(coronary artery disease) or acute haemorrhage 7.lung protective ventilation for ALI(Acute lung injury)
8.Avoidance of neuromuscular blockade 9.blood glucose less than 140 mg/dl 10.DVT(Deeo vein thrombosis)/Stress ulcer prophylaxis 11.Appropriate metabolic and nutritional support.
Control group
Active

Outcomes
Primary outcome [1] 2880 0
Mortality
Timepoint [1] 2880 0
At 28 days
Secondary outcome [1] 4860 0
Mortality
Timepoint [1] 4860 0
At 90 days
Secondary outcome [2] 4861 0
Morbidity measured using the following scores:
SOFA:(Sequential Organ Function Assessment)
ADL:(Activity of Daily Living)
TISS:(Therapeutic Intervention Scoring System)
Timepoint [2] 4861 0
At 28 days

Eligibility
Key inclusion criteria
1.severe sepsis2.APACHE(Acute physiologic and chronic health evaluation) Score>203.Less than 24 hours from the diagnosis of sepsis.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Pregnant patients2.lactating women3.age<18 years old4.>24 hours from the diagnosis of sepsis

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 randomization by using a randomization table creatd by a computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2196 0
University
Name [1] 2196 0
Faculty of Pharmacy (Tehran University of Medical Sciences)
Country [1] 2196 0
Iran, Islamic Republic Of
Funding source category [2] 2197 0
Commercial sector/Industry
Name [2] 2197 0
Pars Company
Country [2] 2197 0
Primary sponsor type
University
Name
Tehran University of Medical Sciences,faculty of pharmacy
Address
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 1984 0
Commercial sector/Industry
Name [1] 1984 0
Pars Company
Address [1] 1984 0
Country [1] 1984 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3994 0
Ethics committee of Tehran University of Medical Sciences
Ethics committee address [1] 3994 0
Ethics committee country [1] 3994 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 3994 0
Approval date [1] 3994 0
04/07/2007
Ethics approval number [1] 3994 0
425/421

Summary
Brief summary
Sepsis is one of the greatest medical problems in over the worlds. Unfortunately nowadays despite all technical and therapeutic progresses (mechanical ventilation, nutritional support, antimicrobial therapies, hemodialysis, vasopressor support, surgical ways,...) mortality due to sepsis is not changed. IMOD(Imunomodulating Drug) is a new remedy drug which increases(count differentiation) CD4 significantly in patients with AIDS(Acquired immunodefiency syndrome).IMOD has strong anti inflammatory effects and induces immune system without any significant side effect. So we decided to evaluate the effect of this drug in improvement of patients with severe sepsis. In this study 30 patients with severe sepsis(Acute Physiologic And Chronic Health Evaluation score>20) were randomized to two 15 patients group, which receive standard treatment of sepsis including early goal directed resuscitation, appropriate diagnostic study, early broad spectrum antibiotics, narrowing antibiotic based on microbial and clinical data, stress dose steroid for septic shock, target Hemoglubin value of 7-9 gram/dlit in absence of CAD(coronary Artey Disease) or acute hemorrhage, Lung protective ventilation for ALI(Acute Lung Injury), avoidance of neuromuscular blockade, blood glucose<140,DVT(Deep Vein Thrombosis)/Stress ulcer prophylaxis. Routine lab exams and monitoring was performed for all patients daily till 14 days. Demographic data were noted. IMOD group received IMOD with the dosage of 10mililitre/day(infusion during one hour) via Central venous line in addition to standard treatment for 14 days. Biomarker levels were measured on the 1st, 2nd, 3rd, 5th and 14th days. These biomarkers are TNF(Tumor necrosis Fator), IL-1(Interleukin-1),IL-6(Interleukin-6),nitrite and nitrate, PAI-I(Plasminogen Activator Inhibitor), Total neutrophil count, Total antioxidant power, D dimer. In the IMOD group mean time between initiation of the signs of sepsis and initiation of IMOD was noted (with 6 hours interval) in order to see whether early infusion of drug decrease mortality or not. patients observed for 28 days(672 hours after initiation of IMOD)or till death. Mortality due to any causes after 28 days and also mortality during 90 days were determined. We determined morbidity of patient during study with using following scoring system: TISS score(Therapeutic Intervention Scoring System) for evaluating the intensity of ICU9Intensive Care Unit) care, SOFA score(Sequential Organ Failure Assessment) for determining organ dysfunction, ADL score(Activity of Daily Living) for determining activities of daily living. These scoring system were performed on the recovered patients in each group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27632 0
Address 27632 0
Country 27632 0
Phone 27632 0
Fax 27632 0
Email 27632 0
Contact person for public queries
Name 11007 0
AtaMahmoodpour
Address 11007 0
General ICU
Sina Hospital
Imam Khomeini Street
Tehran
Country 11007 0
Iran, Islamic Republic Of
Phone 11007 0
00989141160888
Fax 11007 0
Email 11007 0
[email protected]
Contact person for scientific queries
Name 1935 0
Ata Mahmoodpour
Address 1935 0
General ICU
Sina Hospital
Imam Khomeini Street
Tehran
Country 1935 0
Iran, Islamic Republic Of
Phone 1935 0
00989141160888
Fax 1935 0
Email 1935 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

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