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Plasma Neutrophil Gelatinase Associated Lipocalin Levels During Emergency Management of Rhabdomyolysis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01544231
First Posted: March 5, 2012
Last Update Posted: December 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
  Purpose
This research project consists of a prospective diagnostic study conducted on patients with clinical suspicion of rhabdomyolysis admitted to the emergency rooms of the University Hospitals of Nimes, Montpellier, Paris, Nice and Toulon Inter Army Hospital. The main objective of this study is to determine whether the plasma level of Neutrophil Gelatinase Associated Lipocalin (NGAL) may be retained as a predictor of acute renal failure (ARF) occurring within 48 hours after admission for rhabdomyolysis.

Condition Intervention
Rhabdomyolysis Acute Kidney Failure Biological: Plasma NGAL level

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Plasma Neutrophil Gelatinase Associated Lipocalin (NGAL) Levels During Emergency Management of Rhabdomyolysis: Predicting Renal Failure

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Plasma NGAL level [ Time Frame: Admittance to the ermergency room (ie at baseline) ]
    ng/ml


Secondary Outcome Measures:
  • Delay between initiation of treatment and beginning of acute renal failure [ Time Frame: Day 2 ]
    meaured in hours

  • Delay between cause and treatment [ Time Frame: Day 2 ]
    Hours elapsed between proposed cause of rhabdomyolysis and treatment initiation measured in hours.

  • Need for extracorporeal blood purification [ Time Frame: Hospital discharge (expected average of 2-3 days) ]
    yes/no

  • Patient admitted to ICU? [ Time Frame: Hospital discharge (expected average of 2-3 days) ]
    yes/no

  • Length of hospitalization [ Time Frame: Hospital discharge (expected average of 2-3 days) ]
    measured in days

  • Patient deceased during hospitalization [ Time Frame: Hospital discharge (expected average of 2-3 days) ]
    yes/no


Enrollment: 197
Study Start Date: August 2013
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients
Adult patients with suspected rhabdomyolysis admitted to the participating University Hospital emergency rooms (see inclusion/exclusion criteria).
Biological: Plasma NGAL level
The plasmatic level of Neutrophil Gelatinase Associated Lipocalin is measured in ng/ml/

Detailed Description:

The secondary objectives of this are:

  • to study plasma NGAL levels on admission to the emergency ward as a marker of morbidity and mortality by considering the following factors: duration of hospitalization, need for extracorporeal blood purification, ICU admission, death.
  • to study the delay between the onset of the proposed cause of rhabdomyolysis and treatment initiation
  • to study the delay between treatment initiation and the occurrence of ARF.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with suspected rhabdomyolysis admitted to the participating University Hospital emergency rooms (see inclusion/exclusion criteria).
Criteria

Inclusion Criteria:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • Patient hospitalized with Creatine Phospho-Kinase > 1000 UI/l

Exclusion Criteria:

  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient is pregnant, parturient, or breastfeeding
  • Chronic renal insufficiency with dialysis
  • The patient has an acute coronary syndrome
  • Nephrotoxic medications within 72 hours prior to admission
  • Need for a procedure involving the injection of iodine
  • Patient in shock
  • Occurrence of acute renal failure can be explained by a cause other than rhabdomyolysis.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01544231


Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, Gard, France, 30029
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, France, 34295
CHU de Nice - Hôpital St-Roch
Nice, France, 06006
APHP - Groupe Hospitalier Pitié-Salpetrière
Paris Cedex 13, France, 75651
Hôpital Interarmées Sainte Anne
Toulon, France, 83800
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Stéphane Pommet, MD Centre Hospitalier Universitaire de Nîmes
  More Information

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01544231     History of Changes
Other Study ID Numbers: PHRC-I/2011/SP-03
2011-A01059-32 ( Other Identifier: RCB number )
First Submitted: February 23, 2012
First Posted: March 5, 2012
Last Update Posted: December 14, 2015
Last Verified: December 2015

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Neutrophil Gelatinase Associated Lipocalin
predicting acute kidney failure
emergency room

Additional relevant MeSH terms:
Emergencies
Renal Insufficiency
Acute Kidney Injury
Rhabdomyolysis
Disease Attributes
Pathologic Processes
Kidney Diseases
Urologic Diseases
Muscular Diseases
Musculoskeletal Diseases