NCT01594788

Brief Summary

Observational study aimed to test the ability of Neutrophil Gelatinase-associated Lipocalin (NGAL) concentration in blood and urine to predict and diagnose early acute renal failure (ARF) in patients after cardiac surgery with/without Cardiopulmonary bypass (CPB).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
340

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 9, 2012

Status Verified

January 1, 2012

First QC Date

May 7, 2012

Last Update Submit

May 8, 2012

Conditions

Cardiac Surgery

Eligibility Criteria

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

Hospitalised patients

You may qualify if:

  • Men or women over 18 years proposed for cardiac surgery with / without CPB.
  • Accepting to participate in the study, with informed consent signed by the patient, guardian or family member.

You may not qualify if:

  • Patients \< 18 years.
  • Patients do not agree to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

RECRUITING

Central Study Contacts

Mercedes Garcia, MD

CONTACT

+34 93 553 75 41mgarciaa@santpau.cat

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2012

First Posted

May 9, 2012

Study Start

April 1, 2011

Study Completion

December 1, 2012

Last Updated

May 9, 2012

Record last verified: 2012-01

Locations

ES(1)