ANZCTR - Registration

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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

Condition category

Condition code

Blood

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]

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]

Mortality

Timepoint [1]

At 28 days

Secondary outcome [1]

Mortality

Timepoint [1]

At 90 days

Secondary outcome [2]

Morbidity measured using the following scores:
SOFA:(Sequential Organ Function Assessment)
ADL:(Activity of Daily Living)
TISS:(Therapeutic Intervention Scoring System)

Timepoint [2]

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?

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

Accrual to date

Final

Funding & Sponsors

Funding source category [1]

University

Name [1]

Faculty of Pharmacy (Tehran University of Medical Sciences)

Address [1]

Country [1]

Iran, Islamic Republic Of

Funding source category [2]

Commercial sector/Industry

Name [2]

Pars Company

Address [2]

Country [2]

Primary sponsor type

University

Name

Tehran University of Medical Sciences,faculty of pharmacy

Address

Country

Iran, Islamic Republic Of

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Pars Company

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics committee of Tehran University of Medical Sciences

Ethics committee address [1]

Ethics committee country [1]

Iran, Islamic Republic Of

Date submitted for ethics approval [1]

Approval date [1]

04/07/2007

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

AtaMahmoodpour

Address

General ICU
Sina Hospital
Imam Khomeini Street
Tehran

Country

Iran, Islamic Republic Of

Phone

00989141160888

Fax

dr_am5757@yahoo.com

Contact person for scientific queries

Name

Ata Mahmoodpour

Address

General ICU
Sina Hospital
Imam Khomeini Street
Tehran

Country

Iran, Islamic Republic Of

Phone

00989141160888

Fax

dr_am5757@yahoo.com

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.

Trial Review

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