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Plasma Neutrophil Gelatinase Associated Lipocalin Levels During Emergency Management of Rhabdomyolysis

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01544231
First received: February 23, 2012
Last updated: March 4, 2014
Last verified: March 2014
  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) ] [ Designated as safety issue: No ]
    ng/ml


Secondary Outcome Measures:
  • Delay between initiation of treatment and beginning of acute renal failure [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
    meaured in hours

  • Delay between cause and treatment [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    yes/no

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

  • Length of hospitalization [ Time Frame: Hospital discharge (expected average of 2-3 days) ] [ Designated as safety issue: No ]
    measured in days

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


Estimated Enrollment: 197
Study Start Date: August 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544231

Contacts
Contact: Stéphane Pommet, MD +33.(0)4.66.68.30.50 stephane.pommet@chu-nimes.fr
Contact: Carey M Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 09, Gard, France, 30029
Principal Investigator: Stéphane Pommet, MD         
Sub-Investigator: Jean Emmanuel de la Coussaye, MD PhD         
Sub-Investigator: Jean Flechet, MD         
Sub-Investigator: Pierre Géraud, MD         
Sub-Investigator: Xavier Bobbia, MD         
Sub-Investigator: Jean Marie Bonnec, MD         
Sub-Investigator: Serge Lumbroso, MD PhD         
CHU de Montpellier - Hôpital Lapeyronie Recruiting
Montpellier, France, 34295
Sub-Investigator: Jean Jacques Eledjam, MD PhD         
Sub-Investigator: Benoît Aubert, MD         
Sub-Investigator: Riad Jreige, MD         
Sub-Investigator: Emmanuel Guedj, MD         
Sub-Investigator: Mustapha Sebbane, MD         
CHU de Nice - Hôpital St-Roch Recruiting
Nice, France, 06006
Sub-Investigator: Jacques Levraut, MD PhD         
Sub-Investigator: Isabelle Burgos, MD         
APHP - Groupe Hospitalier Pitié-Salpetrière Recruiting
Paris Cedex 13, France, 75651
Sub-Investigator: Bruno Riou, MD PhD         
Sub-Investigator: Mathieu Raux, MD         
Sub-Investigator: Sabine Roche, MD         
Sub-Investigator: Olivier Langeron, MD PhD         
Sub-Investigator: Nicolas Boccheciampe, MD         
Sub-Investigator: Aurélie Birenbaum, Md         
Sub-Investigator: Frédéric Le Saché, MD         
Hôpital Interarmées Sainte Anne Recruiting
Toulon, France, 83800
Sub-Investigator: Bruno Palmier, MD PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Stéphane Pommet, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

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
Study First Received: February 23, 2012
Last Updated: March 4, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

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

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

ClinicalTrials.gov processed this record on August 28, 2014