NCT01227122

Brief Summary

Primary endpoint: To evaluate predictive value of plasmatic levels of Neutrophil Gelatinase Associated Lipocalin (NGAL) to reveal acute kidney failure after cardiac surgery in patients with preoperative chronic kidney failure Secondary endpoint is to obtain threshold values of NGAL.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2010

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

March 4, 2013

Status Verified

March 1, 2013

Enrollment Period

2.9 years

First QC Date

October 22, 2010

Last Update Submit

March 1, 2013

Conditions

Preoperative KIDNEY FAILURE, CHRONICPostoperative KIDNEY FAILURE, ACUTECardiac Surgical Procedures

Keywords

NGAL plasmatic levelPreoperative KIDNEY FAILURE, CHRONICPostoperative KIDNEY FAILURE, ACUTECardiac Surgery Procedures

Outcome Measures

Primary Outcomes (1)

  • Neutrophil Gelatinase Associated Lipocalin (NGAL) level

    From surgery to discharge from hospital

Eligibility Criteria

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

Patients with a chronic kidney failure, undergoing cardiac surgery.

You may qualify if:

  • Renal clearance less than 60 mL/min
  • Able to give written consent
  • Elective valve surgery
  • Elective CABG surgery

You may not qualify if:

  • Less than 18 years old
  • Iodine injection within 3 days before surgery
  • Iodine injection within 24 first postoperative hours
  • preoperative infection
  • evolutive cancer disease
  • Refusal
  • Pregnancy
  • Unable to give written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier Universitaire (CHU) Jean Minjoz

Besançon, Franche-Comté, 25000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Organizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Officials

  • Chocron Sidney, MD, PhD

    Centre Hospitalier Universitaire (CHU) Jean Minjoz, Besançon, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 22, 2010

First Posted

October 25, 2010

Study Start

August 1, 2010

Primary Completion

July 1, 2013

Study Completion

September 1, 2013

Last Updated

March 4, 2013

Record last verified: 2013-03

Locations

FR(1)