Trial record 1 of 5 for:
Open Studies | "Rhabdomyolysis"
Plasma Neutrophil Gelatinase Associated Lipocalin Levels During Emergency Management of Rhabdomyolysis
This study is not yet open for participant recruitment.
Verified May 2013 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01544231
First received: February 23, 2012
Last updated: May 14, 2013
Last verified: May 2013
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Purpose
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 | Intervention |
|---|---|
|
Rhabdomyolysis Acute Kidney Failure |
Biological: Plasma NGAL level |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Plasma Neutrophil Gelatinase Associated Lipocalin (NGAL) Levels During Emergency Management of Rhabdomyolysis: Predicting Renal Failure |
Further study details as provided by Centre Hospitalier Universitaire de Nīmes:
Primary Outcome Measures:
- Plasma NGAL level [ Time Frame: Admittance to the ermergency room (ie at baseline) ] [ Designated as safety issue: No ]ng/ml
Secondary Outcome Measures:
- Delay between initiation of treatment and beginning of acute renal failure [ Time Frame: Day 2 ] [ Designated as safety issue: No ]meaured in hours
- Delay between cause and treatment [ Time Frame: Day 2 ] [ Designated as safety issue: No ]Hours elapsed between proposed cause of rhabdomyolysis and treatment initiation measured in hours.
- Need for extracorporeal blood purification [ Time Frame: Hospital discharge (expected average of 2-3 days) ] [ Designated as safety issue: No ]yes/no
- Patient admitted to ICU? [ Time Frame: Hospital discharge (expected average of 2-3 days) ] [ Designated as safety issue: No ]yes/no
- Length of hospitalization [ Time Frame: Hospital discharge (expected average of 2-3 days) ] [ Designated as safety issue: No ]measured in days
- Patient deceased during hospitalization [ Time Frame: Hospital discharge (expected average of 2-3 days) ] [ Designated as safety issue: No ]yes/no
| Estimated Enrollment: | 197 |
| Study Start Date: | June 2013 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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/
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Adult patients with suspected rhabdomyolysis admitted to the participating University Hospital emergency rooms (see inclusion/exclusion criteria).
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544231
Contacts
| Contact: Stéphane Pommet, MD | +33.(0)4.66.68.30.50 | stephane.pommet@chu-nimes.fr |
| Contact: Carey M Suehs, PhD | +33.(0)4.66.68.67.88 | carey.suehs@chu-nimes.fr |
Locations
| France | |
| CHU de Nîmes - Hôpital Universitaire Carémeau | Not yet recruiting |
| Nîmes Cedex 09, Gard, France, 30029 | |
| Principal Investigator: Stéphane Pommet, MD | |
| Sub-Investigator: Jean Emmanuel de la Coussaye, MD PhD | |
| Sub-Investigator: Jean Flechet, MD | |
| Sub-Investigator: Pierre Géraud, MD | |
| Sub-Investigator: Xavier Bobbia, MD | |
| Sub-Investigator: Jean Marie Bonnec, MD | |
| Sub-Investigator: Serge Lumbroso, MD PhD | |
| CHU de Montpellier - Hôpital Lapeyronie | Not yet recruiting |
| Montpellier, France, 34295 | |
| Sub-Investigator: Jean Jacques Eledjam, MD PhD | |
| Sub-Investigator: Benoît Aubert, MD | |
| Sub-Investigator: Riad Jreige, MD | |
| Sub-Investigator: Emmanuel Guedj, MD | |
| Sub-Investigator: Mustapha Sebbane, MD | |
| CHU de Nice - Hôpital St-Roch | Not yet recruiting |
| Nice, France, 06006 | |
| Sub-Investigator: Jacques Levraut, MD PhD | |
| Sub-Investigator: Isabelle Burgos, MD | |
| APHP - Groupe Hospitalier Pitié-Salpetrière | Not yet recruiting |
| Paris Cedex 13, France, 75651 | |
| Sub-Investigator: Bruno Riou, MD PhD | |
| Sub-Investigator: Mathieu Raux, MD | |
| Sub-Investigator: Sabine Roche, MD | |
| Sub-Investigator: Olivier Langeron, MD PhD | |
| Sub-Investigator: Nicolas Boccheciampe, MD | |
| Sub-Investigator: Aurélie Birenbaum, Md | |
| Sub-Investigator: Frédéric Le Saché, MD | |
| Hôpital Interarmées Sainte Anne | Not yet recruiting |
| Toulon, France, 83800 | |
| Sub-Investigator: Bruno Palmier, MD PhD | |
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
| Principal Investigator: | Stéphane Pommet, MD | Centre Hospitalier Universitaire de Nîmes |
More Information
No publications provided
| Responsible Party: | Centre Hospitalier Universitaire de Nīmes |
| ClinicalTrials.gov Identifier: | NCT01544231 History of Changes |
| Other Study ID Numbers: | PHRC-I/2011/SP-03, 2011-A01059-32 |
| Study First Received: | February 23, 2012 |
| Last Updated: | May 14, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Committee for the Protection of Personnes |
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
|
Neutrophil Gelatinase Associated Lipocalin predicting acute kidney failure emergency room |
Additional relevant MeSH terms:
|
Emergencies Acute Kidney Injury Renal Insufficiency Rhabdomyolysis Disease Attributes |
Pathologic Processes Kidney Diseases Urologic Diseases Muscular Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013