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ISRCTN
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ISRCTN28863830
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ClinicalTrials.gov identifier
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Public title
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The effects of Immunoglobulin M (IgM) enriched immunoglobulin preparations in patients with severe sepsis
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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To evaluate the effect of IgM-enriched immunoglobulin treatment on progression of organ failure and septic shock in patients with severe sepsis.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Turkey
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Disease/condition/study domain
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Severe sepsis
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Participants - inclusion criteria
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Thirty-nine patients with severe sepsis, defined as:
1. Temperature of greater than 38°C or less than 36°C
2. Heart rate of greater than 90 beats/min
3. Respiratory rate greater than 20/min or arterial carbon dioxide pressure (PaCO2) less than 32 mmHg
4. White blood cell count greater than 12000/mm^3 or less than 4000/mm^3
5. Documented infection and dysfunction of an organ or hypotension
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Participants - exclusion criteria
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Does not comply with above inclusion criteria
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Anticipated start date
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01/01/2000
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Anticipated end date
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01/01/2001
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Status of trial
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Completed
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Patient information material
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Target number of participants
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39
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Interventions
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Patients in the study group (n = 21) received intravenous immunoglobulin preparation (Pentaglobin®) in addition to standard therapy. Pentaglobin® was started on the day of diagnosis of severe sepsis. 5 mL/kg/day Pentaglobin® (38 g/L IgG, 6 g/L IgM and 6 g/L IgA) was infused over 6 hours and repeated for three consecutive days.
Patients in the control group (n = 18) received standard sepsis therapy, but no immunoglobulin administration. Blood samples for procalcitonin measurements were taken daily for eight days. Severity of critical illness and development of organ failures were assessed by obtaining daily Acute Physiological and Chronic Health Evaluation II and Sequential Organ Failure Assessment scores.
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Primary outcome measure(s)
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Procalcitonin (PCT) measurements; blood samples were taken daily for eight days following study admission.
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Secondary outcome measure(s)
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1. Severity of critical illness, assessed by obtaining daily acute physiological and chronic health evaluation score (APACHE II)
2. Sequential organ failure assessment (SOFA) score used to assess the development of organ failure
3. Duration of mechanical ventilation
4. Length of stay in the intensive care unit
5. Septic shock incidence
6. 28-day mortality rate
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Sources of funding
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Not provided at time of registration
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/12225613
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Contact name
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Dr
Simru
Tugrul
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Address
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IU Istanbul Tip Fakültesi Anesteziyoloji AD
Cerrahi Monoblok
Çapa
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City/town
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Istanbul
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Zip/Postcode
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34390 Fatih
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Country
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Turkey
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Tel
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+90 (9)212 6318767
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Fax
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+90 (9)212 5332083
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Email
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mtugrul@isbank.net.tr
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Sponsor
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Istanbul University (Turkey)
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Address
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Anesthesiology Department
Istanbul Medical Faculty
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City/town
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Istanbul
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Zip/Postcode
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-
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Country
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Turkey
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Sponsor website:
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http://www.istanbul.edu.tr/english/
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Date applied
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29/04/2002
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Last edited
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07/03/2008
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Date ISRCTN assigned
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29/04/2002
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