Clinical Trial: Plasma Neutrophil Gelatinase Associated Lipocalin Levels During Emergency Management of Rhabdomyolysis

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Plasma Neutrophil Gelatinase Associated Lipocalin (NGAL) Levels During Emergency Management of Rhabdomyolysis: Predicting Renal Failure

Brief Summary: 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.

Detailed Summary:

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.

Sponsor: Centre Hospitalier Universitaire de Nīmes

Current Primary Outcome: Plasma NGAL level [ Time Frame: Admittance to the ermergency room (ie at baseline) ]

ng/ml


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Nīmes

Dates:
Date Received: February 23, 2012
Date Started: August 2013
Date Completion:
Last Updated: December 11, 2015
Last Verified: December 2015