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The Impact of IVIG Treatment on Critical Illness Polyneuropathy and/or Myopathy in Patients With MOF and SIRS/Sepsis

NCT01867645 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2013-06-04

No results posted yet for this study

Summary

Critical illness polyneuropathy and/or myopathy (CIPNM) is a severe complication of critical illness. Retrospective data suggest that early application of IgM-enriched intravenous immunoglobulin (IVIG) may prevent or mitigate CIPNM. Therefore, the primary objective was to assess the effect of early IgM-enriched IVIG versus placebo to mitigate CIPNM in a prospective setting.

Conditions

  • Polyneuropathies

Interventions

DRUG

IgM-enriched Intravenous Immunoglobulins

IgM-enriched IVIG (Pentaglobin, Biotest Pharma GmbH, Dreieich, Germany) at a dose of 0.25g/kg body weight/day as a continuous intravenous infusion at a rate of 2g/h over a period of 3 days.

DRUG

Human Albumin

Human albumin 1% (Biotest Pharma GmbH, Dreieich, Germany) as placebo at a dose of 0.25g/kg body weight/day as a continuous intravenous infusion at a rate of 2g/h over a period of 3 days

Sponsors & Collaborators

  • Biotest Pharma GmbH

    collaborator UNKNOWN

  • National Bank of Austria

    collaborator OTHER_GOV

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Christian Madl, MD · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2009-04-30
Completion
2011-04-30

Countries

  • Austria

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 NCT01867645 on ClinicalTrials.gov