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Evaluating the effect of new remedy IMOD (Imunomodulating Drug)in the treatment of adult patients with sever sepsis

Evaluating the effect of new remedy IMOD(Imunomodulating Drug) on the mortality of adult patients with sever sepsis in Sina Hospital

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000376448
Enrollment
25
Registered
2007-07-16
Start date
2007-08-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 unti

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.

Sponsors

Tehran University of Medical Sciences,faculty of pharmacy
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1.severe sepsis2.APACHE(Acute physiologic and chronic health evaluation) Score>203.Less than 24 hours from the diagnosis of sepsis.

Exclusion criteria

1.Pregnant patients2.lactating women3.age<18 years old4.>24 hours from the diagnosis of sepsis

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026