Plasma Neutrophil Gelatinase Associated Lipocalin Levels During Emergency Management of Rhabdomyolysis
- Conditions
- Acute Kidney FailureRhabdomyolysis
- Interventions
- Biological: Plasma NGAL level
- Registration Number
- NCT01544231
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 197
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients Plasma NGAL level Adult patients with suspected rhabdomyolysis admitted to the participating University Hospital emergency rooms (see inclusion/exclusion criteria).
- Primary Outcome Measures
Name Time Method Plasma NGAL level Admittance to the ermergency room (ie at baseline) ng/ml
- Secondary Outcome Measures
Name Time Method Need for extracorporeal blood purification Hospital discharge (expected average of 2-3 days) yes/no
Delay between cause and treatment Day 2 Hours elapsed between proposed cause of rhabdomyolysis and treatment initiation measured in hours.
Patient deceased during hospitalization Hospital discharge (expected average of 2-3 days) yes/no
Patient admitted to ICU? Hospital discharge (expected average of 2-3 days) yes/no
Delay between initiation of treatment and beginning of acute renal failure Day 2 meaured in hours
Length of hospitalization Hospital discharge (expected average of 2-3 days) measured in days
Trial Locations
- Locations (5)
CHU de Nice - Hôpital St-Roch
🇫🇷Nice, France
APHP - Groupe Hospitalier Pitié-Salpetrière
🇫🇷Paris Cedex 13, France
Hôpital Interarmées Sainte Anne
🇫🇷Toulon, France
CHU de Montpellier - Hôpital Lapeyronie
🇫🇷Montpellier, France
CHU de Nîmes - Hôpital Universitaire Carémeau
🇫🇷Nîmes Cedex 09, Gard, France