RhabdomyolysisNCT01544231
Plasma Neutrophil Gelatinase Associated Lipocalin Levels During Emergency Management of Rhabdomyolysis
An observational study of Rhabdomyolysis and Acute Kidney Failure, run by Centre Hospitalier Universitaire de Nīmes at 5 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhabdomyolysis, Acute Kidney Failure
- What is being tested?
- Plasma NGAL level
- How many people
- 197 participants
- Where
- 5 sitesFrance
- Study dates
- Aug 2013to 9 Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with suspected rhabdomyolysis admitted to the participating University Hospital emergency rooms (see inclusion/exclusion criteria).
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, 34295
CHU de Nice - Hôpital St-Roch
Nice, 06006
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, Gard, 30029
APHP - Groupe Hospitalier Pitié-Salpetrière
Paris, 75651
Hôpital Interarmées Sainte Anne
Toulon, 83800
About this study
Official title: 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.
Read the 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.
- Conditions
- Rhabdomyolysis, Acute Kidney Failure
- Being tested
- Plasma NGAL level
- Keywords
- Neutrophil Gelatinase Associated Lipocalin, predicting acute kidney failure, emergency room
- Medical subject headings
- Rhabdomyolysis, Acute Kidney Injury, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma NGAL levelBiological
The plasmatic level of Neutrophil Gelatinase Associated Lipocalin is measured in ng/ml/
| Study group | Role | What they receive |
|---|---|---|
| Patients | Adult patients with suspected rhabdomyolysis admitted to the participating University Hospital emergency rooms (see inclusion/exclusion criteria). Receives: Biological: Plasma NGAL level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma NGAL level
ng/ml
Measured: Admittance to the ermergency room (ie at baseline)
Secondary outcomes (6)
Delay between initiation of treatment and beginning of acute renal failure
meaured in hours
Measured: Day 2
Delay between cause and treatment
Hours elapsed between proposed cause of rhabdomyolysis and treatment initiation measured in hours.
Measured: Day 2
Need for extracorporeal blood purification
yes/no
Measured: Hospital discharge (expected average of 2-3 days)
Patient admitted to ICU?
yes/no
Measured: Hospital discharge (expected average of 2-3 days)
Length of hospitalization
measured in days
Measured: Hospital discharge (expected average of 2-3 days)
Patient deceased during hospitalization
yes/no
Measured: Hospital discharge (expected average of 2-3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startAug 2013
- Primary completion9 Dec 2015
- Study completion9 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RhabdomyolysisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane Pommet, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544231
- Sponsor's protocol ID
- PHRC-I/2011/SP-03
- Other IDs
- 2011-A01059-32
- Status last verified
- Dec 2015
- First submitted
- 23 Feb 2012
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 39551581
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Neutrophil Gelatinase Associated Lipocalin (NGAL) Levels During Emergency Management of Rhabdomyolysis: Predicting Renal Failure
- ClinicalTrials.gov ID
- NCT01544231
- Acronym / sponsor ID
- PHRC-I/2011/SP-03
- Conditions
- Rhabdomyolysis, Acute Kidney Failure
- Keywords
- Neutrophil Gelatinase Associated Lipocalin, predicting acute kidney failure, emergency room
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- 9 Dec 2015 (actual)
- Study completion
- 9 Dec 2015 (actual)
- First posted
- 5 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Biological: Plasma NGAL levelAdult patients with suspected rhabdomyolysis admitted to the participating University Hospital emergency rooms (see inclusion/exclusion criteria). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with suspected rhabdomyolysis admitted to the participating University Hospital emergency rooms (see inclusion/exclusion criteria).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma NGAL levelThe plasmatic level of Neutrophil Gelatinase Associated Lipocalin is measured in ng/ml/ | Biological | Patients |
Primary outcome
Plasma NGAL level
Time frame: Admittance to the ermergency room (ie at baseline)
ng/ml
6 secondary outcomes
Delay between initiation of treatment and beginning of acute renal failure
Time frame: Day 2
Delay between cause and treatment
Time frame: Day 2
Need for extracorporeal blood purification
Time frame: Hospital discharge (expected average of 2-3 days)
Patient admitted to ICU?
Time frame: Hospital discharge (expected average of 2-3 days)
Length of hospitalization
Time frame: Hospital discharge (expected average of 2-3 days)
Patient deceased during hospitalization
Time frame: Hospital discharge (expected average of 2-3 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publication: PubMed 39551581Pommet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane Pommet, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhabdomyolysis and Acute Kidney Failure, run by Centre Hospitalier Universitaire de Nīmes at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma NGAL level (time frame: Admittance to the ermergency room (ie at baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01544231, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.