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CompletedNCT02108405Updated Apr 9, 2014

The Value of Memory B Cells Marker (CD27) and Howell Jelly Bodies Detrection in Critically Ill Patients

An observational study in Sepsis, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-04-09.

Sponsored by Tanta University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
96
Ages
18 Years to 70 Years
Sex
All
01

Study summary

A total of ninety - five patients (54men and 41women) were included in the study. Fifty-eight patients developed septic complication during ICU stay (sepsis group). Forty seven patients were critically ill without evidence of infectious organism (SIRS group). At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis were measured. Routine cultures were obtained. The attending physician evaluated the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. Memory B cells and Heinz bodies were monitored.

Read the detailed description

The patients staying in ICU for more than 24 hours were enrolled in the study. Patients received anti-inflammatory drugs or corticosteroids before admission, patients had immunosuppressive illness, patients had chronic organ failure; patients received massive blood transfusion; patients with radiation therapy and patients with previous organ transplantation were excluded from the study. At admission, patient's age, sex, weight and height were recorded. Patients data that include the clinical status; sequential organ failure assessment (SOFA) score; temperature; heart rate; respiratory rate; blood pressure; central venous pressure; laboratory analysis (complete blood count, blood urea nitrogen, blood sugar, serum sodium, potassium, calcium, aspartate aminotransferase, alanine aminotransferase, prothrombin time, albumin and CRP) and arterial blood gas analysis were measured. Routine cultures of suspected sites, blood and urine were obtained to determine the presence of infection. We attempted to maintain the patient hemoglobin level at 10-12g/dl and central venous pressure at 8-12 cmH2o. When needed, intravascular fluid replacement, blood products and inotropic or vasopressor agents were administered. Each day the attending physician evaluated all the study patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU.

02

Conditions studied

  • Sepsis

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Keywords

  • critically ill patient.
03

In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

This study's enrollment of 96 is below the median of 130 across 867 observational studies indexed under Critical Illness.

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Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

A total of ninety five patients were included in the study. fifty eight patients developed septic complication during ICU stay (sepsis group). fifty seven patients were critically ill without evidence of infectious organism (SIRS group). At admission, the patient's age, sex, height and weight were recorded.

Inclusion criteria

  • Critically ill patients with manifestation of sepsis or SIRS

Exclusion criteria

Exclusion Criteria:

  • Patients received anti-inflammatory drugs or corticosteroids before admission, who had immunosuppressive illness, who had chronic organ failure; who had received massive blood transfusion; those with radiation therapy, previous organ transplantation were excluded from the study.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
96 participants (actual)
Patient registry
No

Groups and cohorts

  • Sepsis

    Sepsis Forty eight patients developed septic complication during ICU stay (sepsis group).

  • SIRS group

    SIRS group Forty seven patients were critically ill without evidence of infectious organism (SIRS group).

06

What researchers measure

Primary outcomes

  1. Memory B cells

    Memory B cells detection was made using flowcytometry.

    Time frame: 1 day (At time of ICU admission)

Secondary outcomes

  1. Heinz bodies

    Heinz bodies using flow cytometry

    Time frame: 1 day (At ICU admission)

07

Study locations

1 site
  • Tanta University
    Tanta, Algharbyia 35217, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02108405
Lead sponsor
Tanta University
Responsible party
Ayman Abd Al-maksoud Yousef (Assistant professor, Tanta University) — Principal investigator
First posted
Apr 9, 2014
Start date
May 2013
Primary completion
Jan 2014
Completion
Jan 2014
Last update
Apr 9, 2014

Study contacts

Ayman A Yousef, MD
principal investigator · Assistant Professor

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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