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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by Tehran University of Medical Sciences.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01249222
First Posted: November 29, 2010
Last Update Posted: November 29, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tehran University of Medical Sciences
  Purpose

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.


Condition Intervention
Severe Sepsis Procedure: plasmapheresis Other: plasmapheresis

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pro-inflammatory Cytokines Profile and Mortality Rate of Critically Ill Septic Patients Following Plasma Therapeutic Exchange

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • mortality [ Time Frame: 28 days ]

Estimated Enrollment: 27
Study Start Date: November 2008
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: conventional treatment Other: plasmapheresis
plasmapheresis 5 times every 24-48 hours. the apheresis volume will be 30 ml/kg.
Other Name: plasma exchange
Experimental: Plasmapheresis 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 Name: plasma exchange
Other: plasmapheresis
plasmapheresis 5 times every 24-48 hours. the apheresis volume will be 30 ml/kg.
Other Name: plasma exchange

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe sepsis criteria which were defined by the ACCP/SCCM consensus conference

Exclusion Criteria:

  • Post CPR, pregnant and under 16 years old patients
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01249222


Contacts
Contact: mojtaba mojtahedzadeh, Ph.D 009821-6695-9090 Mojtahed@sina.tums.ac.ir

Locations
Iran, Islamic Republic of
Tehran University of Medical sciences, Imam hospital Recruiting
Tehran, Iran, Islamic Republic of, 1417653761
Contact: Mojtaba Mojtahedzadeh, Ph.D    009821-6695-9090    Mojtahed@sina.tums.ac.ir   
Principal Investigator: Hadi Hamishehkar, Pharm.D         
Principal Investigator: Mohammad taghi Beigmohammadi, MD         
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Study Chair: Mojtaba Mojtahedzadeh, Ph.D 1Department of Clinical Pharmacy, Faculty of Pharmacy and Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran.
  More Information

Responsible Party: Pharmaceutical Science research center, PSRC
ClinicalTrials.gov Identifier: NCT01249222     History of Changes
Other Study ID Numbers: D-230-402
First Submitted: November 22, 2010
First Posted: November 29, 2010
Last Update Posted: November 29, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Critical Illness
Sepsis
Disease Attributes
Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome
Inflammation