NCT02108405

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
Last Updated

April 9, 2014

Status Verified

April 1, 2014

Enrollment Period

8 months

First QC Date

March 1, 2013

Last Update Submit

April 8, 2014

Conditions

Keywords

critically ill patient.

Outcome Measures

Primary Outcomes (1)

  • Memory B cells

    Memory B cells detection was made using flowcytometry.

    1 day (At time of ICU admission)

Secondary Outcomes (1)

  • Heinz bodies

    1 day (At ICU admission)

Study Arms (2)

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).

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Critically ill patients with manifestation of sepsis or SIRS

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, Algharbyia, 35217, Egypt

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ayman A Yousef, MD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 1, 2013

First Posted

April 9, 2014

Study Start

May 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

April 9, 2014

Record last verified: 2014-04

Locations