Clinical trial NCT01544231: Plasma Neutrophil Gelatinase Associated Lipocalin Levels During Emergency Management of Rhabdomyolysis
Official title: Plasma Neutrophil Gelatinase Associated Lipocalin (NGAL) Levels During Emergency Management of Rhabdomyolysis: Predicting Renal Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhabdomyolysis
Acute Kidney Failure
Keywords: Neutrophil Gelatinase Associated Lipocalin
predicting acute kidney failure
emergency room
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-03-05
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with suspected rhabdomyolysis admitted to the participating University Hospital emergency rooms (see inclusion/exclusion criteria).

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.

Eligibility 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.

Primary outcomes:
measure: Plasma NGAL level
timeFrame: Admittance to the ermergency room (ie at baseline)
Secondary outcomes:
measure: Delay between initiation of treatment and beginning of acute renal failure
timeFrame: Day 2
measure: Delay between cause and treatment
timeFrame: Day 2
measure: Need for extracorporeal blood purification
timeFrame: Hospital discharge (expected average of 2-3 days)
measure: Patient admitted to ICU?
timeFrame: Hospital discharge (expected average of 2-3 days)
measure: Length of hospitalization
timeFrame: Hospital discharge (expected average of 2-3 days)
measure: Patient deceased during hospitalization
timeFrame: Hospital discharge (expected average of 2-3 days)
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
state: Gard
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Lapeyronie
city: Nice
country: France
facility: CHU de Nice - Hôpital St-Roch
city: Paris Cedex 13
country: France
facility: APHP - Groupe Hospitalier Pitié-Salpetrière
city: Toulon
country: France
facility: Hôpital Interarmées Sainte Anne
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Stéphane Pommet, MD
role: PRINCIPAL_INVESTIGATOR
References: