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Pro-inflammatory Cytokines Profile and Mortality Rate of Critically Ill Septic Patients Following Plasmapheresis

NCT01249222 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2010-11-29

No results posted yet for this study

Summary

Sepsis is one of the most prevalent and fatal diseases in intensive care units .unfortunately, therapeutic approach to sepsis has remained unchanged for many years. Nowadays, the role of cytokines in pathogenesis of sepsis is obvious. Continuous elevated levels of various cytokines in severe sepsis could result in uncontrolled inflammation status. Breaking of inflammatory cascade may lead to improvement in survival. It seems that modulation of inflammation is one of the strategic plans to conquest sepsis. Therefore, elimination of bacterial toxins and pro-inflammatory cytokines from the systemic circulation by plasmapheresis supposed to be rational approach.

Researchers have done several attempts to clarify the efficacy of plasmapheresis in sepsis treatment. However because of inconsistent results, routine use of this procedure in patients with severe sepsis remains controversial.

The aim of the present survey is to determine the effect of plasmapheresis on plasma levels of main pro-inflammatory cytokines and evaluate its therapeutic efficacy in improvement of outcome and treatment of severe sepsis.

Conditions

  • Severe Sepsis

Interventions

PROCEDURE

plasmapheresis

Plasmapheresis was done every 24-48 hours and continues up to five times. Blood samples were collected 30 minutes before and after each session of plasmapheresis to determine sequential changes in plasma levels of IL-1β, IL-6 and TNF-α. During each exchange session a volume of 25-30 ml/kg bodyweight of patient's plasma was exchanged with equal volume of 20% human albumin diluted with normal saline solution. Before and after plasmapheresis, prothrombin time, activated partial thromboplastin time (aPTT), platelet count and serum calcium level were checked. calcium gluconate 10% (10 ml) was administered even if patient had normal serum calcium in order to prevent hypocalcaemia due to administration of citrate. All drugs except for vasopressors were stopped during procedure.

OTHER

plasmapheresis

plasmapheresis 5 times every 24-48 hours. the apheresis volume will be 30 ml/kg.

Sponsors & Collaborators

  • Tehran University of Medical Sciences

    lead OTHER

Principal Investigators

  • Mojtaba Mojtahedzadeh, Ph.D · 1Department of Clinical Pharmacy, Faculty of Pharmacy and Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01249222 on ClinicalTrials.gov