Plasma Neutrophil Gelatinase Associated Lipocalin Levels During Emergency Management of Rhabdomyolysis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The secondary objectives of this are:
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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.
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to study the delay between the onset of the proposed cause of rhabdomyolysis and treatment initiation
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to study the delay between treatment initiation and the occurrence of ARF.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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/
|
Outcome Measures
Primary Outcome Measures
- Plasma NGAL level [Admittance to the ermergency room (ie at baseline)]
ng/ml
Secondary Outcome Measures
- Delay between initiation of treatment and beginning of acute renal failure [Day 2]
meaured in hours
- Delay between cause and treatment [Day 2]
Hours elapsed between proposed cause of rhabdomyolysis and treatment initiation measured in hours.
- Need for extracorporeal blood purification [Hospital discharge (expected average of 2-3 days)]
yes/no
- Patient admitted to ICU? [Hospital discharge (expected average of 2-3 days)]
yes/no
- Length of hospitalization [Hospital discharge (expected average of 2-3 days)]
measured in days
- Patient deceased during hospitalization [Hospital discharge (expected average of 2-3 days)]
yes/no
Eligibility Criteria
Criteria
Inclusion Criteria:
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The patient must have given his/her informed and signed consent
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The patient must be insured or beneficiary of a health insurance plan
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Patient hospitalized with Creatine Phospho-Kinase > 1000 UI/l
Exclusion Criteria:
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The patient is participating in another study
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The patient is in an exclusion period determined by a previous study
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The patient is under judicial protection, under tutorship or curatorship
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The patient refuses to sign the consent
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It is impossible to correctly inform the patient
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The patient is pregnant, parturient, or breastfeeding
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Chronic renal insufficiency with dialysis
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The patient has an acute coronary syndrome
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Nephrotoxic medications within 72 hours prior to admission
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Need for a procedure involving the injection of iodine
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Patient in shock
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Occurrence of acute renal failure can be explained by a cause other than rhabdomyolysis.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes Cedex 09 | Gard | France | 30029 |
| 2 | CHU de Montpellier - Hôpital Lapeyronie | Montpellier | France | 34295 | |
| 3 | CHU de Nice - Hôpital St-Roch | Nice | France | 06006 | |
| 4 | APHP - Groupe Hospitalier Pitié-Salpetrière | Paris Cedex 13 | France | 75651 | |
| 5 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PHRC-I/2011/SP-03
- 2011-A01059-32