Plasma Neutrophil Gelatinase Associated Lipocalin Levels During Emergency Management of Rhabdomyolysis

NCT ID: NCT01544231

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

197 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-12-09

Brief Summary

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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

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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.

Conditions

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Rhabdomyolysis Acute Kidney Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Adult patients with suspected rhabdomyolysis admitted to the participating University Hospital emergency rooms (see inclusion/exclusion criteria).

Plasma NGAL level

Intervention Type BIOLOGICAL

The plasmatic level of Neutrophil Gelatinase Associated Lipocalin is measured in ng/ml/

Interventions

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Plasma NGAL level

The plasmatic level of Neutrophil Gelatinase Associated Lipocalin is measured in ng/ml/

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stéphane Pommet, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, France

Site Status

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, , France

Site Status

CHU de Nice - Hôpital St-Roch

Nice, , France

Site Status

APHP - Groupe Hospitalier Pitié-Salpetrière

Paris, , France

Site Status

Hôpital Interarmées Sainte Anne

Toulon, , France

Site Status

Countries

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France

References

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Pommet S, Coisy F, Demattei C, Balaguer L, de Bauwere DP, Grau-Mercier L, Markarian T, Bobbia X, Genre Grandpierre R. Does serum neutrophil gelatinase-associated lipocalin level predict acute kidney injury in patients with acute rhabdomyolysis in the emergency department? A multicentre prospective study. BMJ Open. 2024 Nov 17;14(11):e088859. doi: 10.1136/bmjopen-2024-088859.

Reference Type RESULT
PMID: 39551581 (View on PubMed)

Other Identifiers

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2011-A01059-32

Identifier Type: OTHER

Identifier Source: secondary_id

PHRC-I/2011/SP-03

Identifier Type: -

Identifier Source: org_study_id

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