NCT00845741

Brief Summary

This study is to evaluate the NGAL point of care device as an aid in the early risk assessment of AKI (acute kidney injury)in an All-Comers ED population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2009

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

February 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

January 24, 2011

Status Verified

October 1, 2010

Enrollment Period

1.3 years

First QC Date

February 16, 2009

Last Update Submit

January 20, 2011

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • Development of Acute Kidney Injury (AKI)

    0 to 48hrs after ED presentation

Secondary Outcomes (1)

  • Assess the severity of AKI in patients using the NGAL device and clinical judgement.

    0-48hrs after ED presentation

Eligibility Criteria

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

Adults presenting to the ED and designated for admission to the hospital will be enrolled.

You may qualify if:

  • Males and females 18 years of age or older;
  • Patients presenting to the ED who have been designated for hospital admission
  • Ability to provide blood samples for baseline NGAL, Cystatin C and creatinine levels either prior to or at admission;
  • Ability to provide written informed consent.

You may not qualify if:

  • Known history of marked chronic renal insufficiency (e.g., usual serum creatinine ³ 3.0 mg/dL), on dialysis or RRT (either acute or chronic) or in imminent need of dialysis or RRT at enrollment;
  • Patients with urothelial malignancies;
  • Patients not expected to be admitted and therefore unable to fulfil protocol requirements for blood collection out to day 3 post admission time points
  • Prisoners or other institutionalized or vulnerable individuals;
  • Participation in an interventional clinical study within the previous 30 days;
  • Unlikely to be willing or able to comply with study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera Sant'Andrea

Rome, Italy

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 16, 2009

First Posted

February 18, 2009

Study Start

February 1, 2009

Primary Completion

June 1, 2010

Study Completion

August 1, 2010

Last Updated

January 24, 2011

Record last verified: 2010-10

Locations

IT(1)