Plasma Neutrophil Gelatinase Associated Lipocalin Levels During Emergency Management of Rhabdomyolysis

Acute Kidney Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544231
• Other study ID #: PHRC-I/2011/SP-03
• Secondary ID: 2011-A01059-32
• Status: Completed
• Phase: N/A
• First received: February 23, 2012
• Last updated: December 11, 2015
• Start date: August 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Failure
• Acute Kidney Injury
• Emergencies
• Renal Insufficiency
• Rhabdomyolysis

Intervention

Biological:
• Plasma NGAL level
The plasmatic level of Neutrophil Gelatinase Associated Lipocalin is measured in ng/ml/

Locations

Country	Name	City	State
France	CHU de Montpellier - Hôpital Lapeyronie	Montpellier
France	CHU de Nice - Hôpital St-Roch	Nice
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09	Gard
France	APHP - Groupe Hospitalier Pitié-Salpetrière	Paris Cedex 13
France	Hôpital Interarmées Sainte Anne	Toulon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma NGAL level	ng/ml	Admittance to the ermergency room (ie at baseline)	No
Secondary	Delay between initiation of treatment and beginning of acute renal failure	meaured in hours	Day 2	No
Secondary	Delay between cause and treatment	Hours elapsed between proposed cause of rhabdomyolysis and treatment initiation measured in hours.	Day 2	No
Secondary	Need for extracorporeal blood purification	yes/no	Hospital discharge (expected average of 2-3 days)	No
Secondary	Patient admitted to ICU?	yes/no	Hospital discharge (expected average of 2-3 days)	No
Secondary	Length of hospitalization	measured in days	Hospital discharge (expected average of 2-3 days)	No
Secondary	Patient deceased during hospitalization	yes/no	Hospital discharge (expected average of 2-3 days)	No