Urinary NGAL Acute Kidney Injury After Stored Red Blood C... | NCT03560921

Studies
Urinary NGAL Acute Kidney Injury After Stored Red Blood Cells Transfusion in Critically Ill Patients.

NCT03560921

Sponsor

Kasr El Aini Hospital

Status

Completed

Last Update Posted

Jun 18, 2018Actual

Enrollment

147Actual

Phase

Not provided

Conditions

Acute Kidney Injury
Anemia

Interventions

urinary NGAL

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2, 2017Actual

Primary Completion Date

Dec 5, 2017Actual

Completion Date

Dec 5, 2017Actual

First Submitted Date

Jun 5, 2018

First Submission Date that Met QC Criteria

Jun 15, 2018

First Posted Date

Jun 18, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2018

Last Update Posted Date

Jun 18, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The investigators will measure the urinary NGAL in all patients who received blood transfusion in the intensive care unit during the study period. The age of PRBCs transfusion will be correlated with the incidence of AKI. The rise of NGAL and serum creatinine will be used to diagnose AKI (Acute Kidney Injury).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

147Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stored blood transfusion		measurement of urinary NGAL	Diagnostic Test: urinary NGAL
Fresh blood transfusion		measurement of urinary NGAL	Diagnostic Test: urinary NGAL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
urinary NGAL	Diagnostic Test	measurement urinary NGAL using the ARCHITECT technique	Fresh blood transfusion Stored blood transfusion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of AKI	Diagnosis of AKI by rise of serum creatinine	within 30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any patients admitted to the intensive care unit.

Exclusion Criteria:

patients who have established AKI at the time of recruitment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients admitted to ICU of any age and sex

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tarek Abdelaziz	faculty of medicine-Cairo University Hospitals	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairo university hospitals		Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury
D000740	Anemia

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided