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A clinical trial to study the effect of G-CSF in sepsis associated immunosupression

Efficacy of Granulocyte colony stimulating factor in sepsis associated immunosupresssion : Open label randomised controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050862
Enrollment
84
Registered
2023-03-20
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Health Condition 1: R098- Other specified symptoms and signsinvolving the circulatory and respiratory systems

Interventions

Intervention1: EFfficacy of G-CSF in sepsis associated immunosupression.: G-CSF will be given for 7days, Dose:-4microgram/kg/day s/c. drug will be stopped if TLC30,000/mm3. Subsequent management will

Sponsors

Banaras Hindu University Varanasi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Multi-organ failure more than or equal to 2 systems and persisting for 3days

Exclusion criteria

Exclusion criteria: Macrophage activation syndrome,ferritin >500mg/dl Thrombocytopenia associated Mukti organ failure(TAMOF) Sequential Multiorgan failure Haematological disease (neoplasm,acute leukaemia) ,transplant patients

Design outcomes

Primary

MeasureTime frame
As per picu record @SSH mortality among IPMOF is 63%. Mortality is defined as death within 28days of PICU stay. Reduction in mortality from 63% among IPMOF to 33%Timepoint: 7days,14days and at 28days during hospital stay

Secondary

MeasureTime frame
Differences in following parameters between 2 groups at various time points during hospitalisation ,organ failure index IL-6,IL-8 , TNF alpha and nosocomial infectionTimepoint: During admitted in picu

Countries

India

Contacts

Public ContactKyatham keerthi

IMS BHU

Kyathamkeerthireddy@gmail.com7702874888

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026