Condition category
Infections and Infestations
Date applied
29/04/2002
Date assigned
29/04/2002
Last edited
07/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Simru Tugrul

ORCID ID

Contact details

IU Istanbul Tip Fakültesi Anesteziyoloji AD
Cerrahi Monoblok
Çapa
Istanbul
34390 Fatih
Turkey
+90 (9)212 6318767
mtugrul@isbank.net.tr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

To evaluate the effect of IgM-enriched immunoglobulin treatment on progression of organ failure and septic shock in patients with severe sepsis.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Severe sepsis

Intervention

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.

Intervention type

Drug

Phase

Not Specified

Drug names

Pentaglobin®

Primary outcome measures

Procalcitonin (PCT) measurements; blood samples were taken daily for eight days following study admission.

Secondary outcome measures

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

Overall trial start date

01/01/2000

Overall trial end date

01/01/2001

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

39

Participant exclusion criteria

Does not comply with above inclusion criteria

Recruitment start date

01/01/2000

Recruitment end date

01/01/2001

Locations

Countries of recruitment

Turkey

Trial participating centre

IU Istanbul Tip Fakültesi Anesteziyoloji AD
Istanbul
34390 Fatih
Turkey

Sponsor information

Organisation

Istanbul University (Turkey)

Sponsor details

Anesthesiology Department
Istanbul Medical Faculty
Istanbul
-
Turkey

Sponsor type

Hospital/treatment centre

Website

http://www.istanbul.edu.tr/english/

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/12225613

Publication citations

  1. Results

    Tugrul S, Ozcan PE, Akinci O, Seyhun Y, Cagatay A, Cakar N, Esen F, The effects of IgM-enriched immunoglobulin preparations in patients with severe sepsis [ISRCTN28863830]., Crit Care, 2002, 6, 4, 357-362.

Additional files

Editorial Notes