Plasma Neutrophil Gelatinase Associated Lipocalin Levels During Emergency Management of Rhabdomyolysis

Plasma Neutrophil Gelatinase Associated Lipocalin (NGAL) Levels During Emergency Management of Rhabdomyolysis: Predicting Renal Failure

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Failure; Rhabdomyolysis
• Intervention / Treatment: Biological: Plasma NGAL level

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.

• Study Type: Observational
• Enrollment (Actual): 197

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • CHU de Montpellier - Hôpital Lapeyronie
  • Nice, France, 06006
    • CHU de Nice - Hôpital St-Roch
  • Paris Cedex 13, France, 75651
    • APHP - Groupe Hospitalier Pitié-Salpetrière
  • Toulon, France, 83800
    • Hôpital Interarmées Sainte Anne
  • Gard
    • Nîmes Cedex 09, Gard, France, 30029
      • CHU de Nimes - Hopital Universitaire Caremeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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/

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma NGAL level	ng/ml	Admittance to the ermergency room (ie at baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delay between initiation of treatment and beginning of acute renal failure	meaured in hours	Day 2
Delay between cause and treatment	Hours elapsed between proposed cause of rhabdomyolysis and treatment initiation measured in hours.	Day 2
Need for extracorporeal blood purification	yes/no	Hospital discharge (expected average of 2-3 days)
Patient admitted to ICU?	yes/no	Hospital discharge (expected average of 2-3 days)
Length of hospitalization	measured in days	Hospital discharge (expected average of 2-3 days)
Patient deceased during hospitalization	yes/no	Hospital discharge (expected average of 2-3 days)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Stéphane Pommet, MD, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: February 23, 2012
• First Submitted That Met QC Criteria: February 28, 2012
• First Posted (Estimate): March 5, 2012

Study Record Updates

• Last Update Posted (Estimate): December 14, 2015
• Last Update Submitted That Met QC Criteria: December 11, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: emergency room; Neutrophil Gelatinase Associated Lipocalin; predicting acute kidney failure
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Musculoskeletal Diseases; Muscular Diseases; Emergencies; Renal Insufficiency; Acute Kidney Injury; Rhabdomyolysis
• Other Study ID Numbers: PHRC-I/2011/SP-03; 2011-A01059-32 (Other Identifier: RCB number)