NCT03560921

Brief Summary

The study aims to explore the association of the novel urinary bio marker NGAL with the age of PRBCs(packed red blood cells) transfusion in critically ill patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
147

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
Last Updated

June 18, 2018

Status Verified

June 1, 2018

Enrollment Period

6 months

First QC Date

June 5, 2018

Last Update Submit

June 15, 2018

Conditions

Acute Kidney InjuryAnemia

Keywords

biomarkers

Outcome Measures

Primary Outcomes (1)

  • Incidence of AKI

    Diagnosis of AKI by rise of serum creatinine

    within 30 days

Study Arms (2)

Stored blood transfusion

measurement of urinary NGAL

Diagnostic Test: urinary NGAL

Fresh blood transfusion

measurement of urinary NGAL

Diagnostic Test: urinary NGAL

Interventions

urinary NGALDIAGNOSTIC_TEST

measurement urinary NGAL using the ARCHITECT technique

Fresh blood transfusionStored blood transfusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients admitted to ICU of any age and sex

You may qualify if:

  • Any patients admitted to the intensive care unit.

You may not qualify if:

  • patients who have established AKI at the time of recruitment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university hospitals

Cairo, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples

MeSH Terms

Conditions

Acute Kidney InjuryAnemia

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Tarek Abdelaziz

    faculty of medicine-Cairo University Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 5, 2018

First Posted

June 18, 2018

Study Start

June 2, 2017

Primary Completion

December 5, 2017

Study Completion

December 5, 2017

Last Updated

June 18, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)