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

NCT01249222 | Unknown DMC

• 1 other identifier: D-230-402
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• mortality

  28 days

Study Arms (2)

conventional treatment

NO INTERVENTION

Other: plasmapheresis

Plasmapheresis

EXPERIMENTAL

Procedure: plasmapheresis; Other: plasmapheresis

Interventions

plasmapheresis PROCEDURE

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.

Also known as: plasma exchange

Plasmapheresis

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Post CPR, pregnant and under 16 years old patients

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Tehran University of Medical sciences, Imam hospital

Tehran, Tehran Province, 1417653761, Iran

RECRUITING

MeSH Terms

Conditions

Sepsis

Interventions

Plasmapheresis; Plasma Exchange

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Component Removal; Therapeutics; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative; Blood Transfusion; Biological Therapy

Study Officials

• Mojtaba Mojtahedzadeh, Ph.D

  1Department of Clinical Pharmacy, Faculty of Pharmacy and Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran.

  STUDY CHAIR

Central Study Contacts

mojtaba mojtahedzadeh, Ph.D

CONTACT

009821-6695-9090; Mojtahed@sina.tums.ac.ir

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 29, 2010
• Study Start: November 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: November 29, 2010

Record last verified: 2010-11

Locations

IR (1)