Plasma Neutrophil Gelatinase Associated Lipocalin Levels During Emergency Management of Rhabdomyolysis

NCT01544231 | Completed

• 2 other identifiers: PHRC-I/2011/SP-032011-A01059-32
• Study Type: observational
• Target: 197
• Locations: 1 country
• Sites: 5

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.

Conditions

Rhabdomyolysis; Acute Kidney Failure

Keywords

Neutrophil Gelatinase Associated Lipocalin; predicting acute kidney failure; emergency room

Outcome Measures

Primary Outcomes (1)

• Plasma NGAL level

  ng/ml

  Admittance to the ermergency room (ie at baseline)

Secondary Outcomes (6)

• Delay between initiation of treatment and beginning of acute renal failure

  Day 2

• Delay between cause and treatment

  Day 2

• Need for extracorporeal blood purification

  Hospital discharge (expected average of 2-3 days)

• Patient admitted to ICU?

  Hospital discharge (expected average of 2-3 days)

• Length of hospitalization

  Hospital discharge (expected average of 2-3 days)

Study Arms (1)

Patients

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

Biological: Plasma NGAL level

Interventions

Plasma NGAL level BIOLOGICAL

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

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• The patient is participating in another 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (5)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029, France

Location

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, 34295, France

Location

CHU de Nice - Hôpital St-Roch

Nice, 06006, France

Location

APHP - Groupe Hospitalier Pitié-Salpetrière

Paris, 75651, France

Location

Hôpital Interarmées Sainte Anne

Toulon, 83800, France

Location

Related Publications (1)

• 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.

  PMID: 39551581 RESULT

MeSH Terms

Conditions

Rhabdomyolysis; Acute Kidney Injury; Emergencies

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stéphane Pommet, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2012
• First Posted: March 5, 2012
• Study Start: August 1, 2013
• Primary Completion: December 9, 2015
• Study Completion: December 9, 2015
• Last Updated: November 19, 2025

Record last verified: 2015-12

Locations

FR (5)