NCT04281888

Brief Summary

  1. 1.To observe the changes in the inflammatory anemiaassociated parameters of patients with sepsis in the early stage of intensive care unit (ICU) admission.
  2. 2.To evaluate their association with 28-days mortality
  3. 3.To evaluate the effect of blood transfusion on these parameters and the survival of the studied patients

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2020

Completed
25 days until next milestone

Study Start

First participant enrolled

March 20, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2021

Completed
Last Updated

February 24, 2020

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

February 20, 2020

Last Update Submit

February 20, 2020

Conditions

Inflammatory Response

Outcome Measures

Primary Outcomes (1)

  • The relation between level of hepcidin, interleukin-6 and hemoglobin with 28-days mortality in 100 ICU septic patients

    Hepicidin level will be measured in day 1,3 and 7 of ICU admission as well as interleukin-6 and hemoglobin and the relation between their level and survival of the studied patients will be evaluated

    Baseline

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients in ICU with sepsis

You may not qualify if:

  • patients less than18 years of age.
  • patients have chronic liver dysfunctions or chronic kidney disease resulting from different causes.
  • patients with known iron related diseases (e.g., hemochromatosis), immunologic diseases or malignancies upon hospital admission; all types of anemia (aplastic, iron deficiency, hemolytic, megaloblastic).
  • patients with overt blood loss (e.g., gastrointestinal bleeding) upon admission and during the ICU stay.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Ganz T, Nemeth E. Iron homeostasis in host defence and inflammation. Nat Rev Immunol. 2015 Aug;15(8):500-10. doi: 10.1038/nri3863. Epub 2015 Jul 10.

    PMID: 26160612BACKGROUND

  • Hegde A. Approach to an Anemic Critically Ill Patient. Indian J Crit Care Med. 2019 Sep;23(Suppl 3):S178-S180. doi: 10.5005/jp-journals-10071-23247.

    PMID: 31656373BACKGROUND

  • Weiss G, Ganz T, Goodnough LT. Anemia of inflammation. Blood. 2019 Jan 3;133(1):40-50. doi: 10.1182/blood-2018-06-856500. Epub 2018 Nov 6.

    PMID: 30401705BACKGROUND

Study Officials

  • Yousreiya A Ahmad, Professor

    Assuit University Hospital

    STUDY DIRECTOR

Central Study Contacts

Heba M Ahmed, Hematologist

CONTACT

00201061343995nfertiti.9981@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hematologist

Study Record Dates

First Submitted

February 20, 2020

First Posted

February 24, 2020

Study Start

March 20, 2020

Primary Completion

March 20, 2021

Study Completion

May 20, 2021

Last Updated

February 24, 2020

Record last verified: 2020-02