RhabdomyolysisRHABDURGENCENCT02896517
Support for the Rhabdomyolysis in an Emergency Department
An observational study of Rhabdomyolysis, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Rhabdomyolysis is a common condition in the UAA. Support is heterogeneous, it is in most cases a mass hyperhydration. The idea is to initially with an EPP simultaneously screened for the most affected by this disease and aggravating factors population, associated comorbidities. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rhabdomyolysis
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2016to 1 Oct 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with rhabdomyolysis admitted to the emergency department of the Hôpitel paris saint joseph
Who may be able to join
- All adults with CPK greater than 5N or 500 IU / L in sera to emergencies
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Rhabdomyolysis is a common condition in the UAA. Support is heterogeneous, it is in most cases a mass hyperhydration. The idea is to initially with an EPP simultaneously screened for the most affected by this disease and aggravating factors population, associated comorbidities.
The rhabdomyolysis prognosis depends mainly on the etiology and associated comorbidities.
Read more
- Acute renal failure and hyperkalemia are the major complications that worsen the prognosis.
- In most cases, acute renal failure is reversible. Acute renal failure caused by renal vasoconstriction with ischemia, precipitation of myoglobin in the tubules and direct cytotoxic action of myoglobin.
If the prime mover of rhabdomyolysis is ischemia (or hypoxia) cell, we now know that the tissue damage is greatly aggravated during muscle reperfusion, creating ischemia-reperfusion. Reperfusion will not only cause the release into the bloodstream of the cell contents myocytes but also an increase in necrotic areas. Indeed, the massive arrival of oxygen at the myocyte will cause significant production of free radicals, increasing their toxic effects.
Predictive factors of acute renal failure is creatinine and urea. The urine alkalinisation by bicarbonates is questionable oral alkalizing seems to be an alternative when possible (oral alkaline solution) but not used to this day.
The track N-acetyl cysteine as an antioxidant that can possibly have an effect on release of the free radicals during reperfusion by decreasing their toxicity is still not considered clinically.
Read the detailed description
Main objective / secondary:
Evaluation of current professional practice:
- Identify the most common etiologies encountered in our SAU. II. Identify the / types of people most affected by this disease III. Detect the most common complications of H0 support and evolution H48 if the patient not transferred IV. Evaluate the emergency treatment at the initial charge.
Methodology :
DESIGN:
It is a non-interventional retrospective single-center study, within the Department of Emergency GHPSJ, to an EPP and output the results regarding the type of population most affected by this disease with the most common etiologies in our support (what we are doing).
Time study:
Study on patient records being passed on to the emergency 12 months out with a diagnosis of rhabdomyolysis.
- Conditions
- Rhabdomyolysis
- Medical subject headings
- Rhabdomyolysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change of patient complication by answering a questionary
Detect the most common complications of Hour 0 support and evolution Hour 48 if the patient not transferred. Hour 0 support and evolution at Hour 48
Measured: Hour 0, Hour 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study start1 Oct 2016 (estimated)
- Primary completion1 Oct 2016 (estimated)
- Study completion1 Oct 2016 (estimated)
Why it stopped: The investigator abandoned the project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhabdomyolysisStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896517
- Sponsor's protocol ID
- RHABDURGENCE
- Acronym
- RHABDURGENCE
- Status last verified
- Aug 2018
- First submitted
- 31 Aug 2016
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Support for the Rhabdomyolysis in an Emergency Department
- ClinicalTrials.gov ID
- NCT02896517
- Acronym / sponsor ID
- RHABDURGENCE / RHABDURGENCE
- Conditions
- Rhabdomyolysis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The investigator abandoned the project.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 1 Oct 2016 (estimated)
- Primary completion
- 1 Oct 2016 (estimated)
- Study completion
- 1 Oct 2016 (estimated)
- First posted
- 12 Sep 2016 (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.
Rhabdomyolysis is a common condition in the UAA. Support is heterogeneous, it is in most cases a mass hyperhydration. The idea is to initially with an EPP simultaneously screened for the most affected by this disease and aggravating factors population, associated comorbidities.
The rhabdomyolysis prognosis depends mainly on the etiology and associated comorbidities.
- Acute renal failure and hyperkalemia are the major complications that worsen the prognosis.
- In most cases, acute renal failure is reversible. Acute renal failure caused by renal vasoconstriction with ischemia, precipitation of myoglobin in the tubules and direct cytotoxic action of myoglobin.
If the prime mover of rhabdomyolysis is ischemia (or hypoxia) cell, we now know that the tissue damage is greatly aggravated during muscle reperfusion, creating ischemia-reperfusion. Reperfusion will not only cause the release into the bloodstream of the cell contents myocytes but also an increase in necrotic areas. Indeed, the massive arrival of oxygen at the myocyte will cause significant production of free radicals, increasing their toxic effects.
Predictive factors of acute renal failure is creatinine and urea. The urine alkalinisation by bicarbonates is questionable oral alkalizing seems to be an alternative when possible (oral alkaline solution) but not used to this day.
The track N-acetyl cysteine as an antioxidant that can possibly have an effect on release of the free radicals during reperfusion by decreasing their toxicity is still not considered clinically.
Detailed description
Main objective / secondary:
Evaluation of current professional practice:
- Identify the most common etiologies encountered in our SAU. II. Identify the / types of people most affected by this disease III. Detect the most common complications of H0 support and evolution H48 if the patient not transferred IV. Evaluate the emergency treatment at the initial charge.
Methodology :
DESIGN:
It is a non-interventional retrospective single-center study, within the Department of Emergency GHPSJ, to an EPP and output the results regarding the type of population most affected by this disease with the most common etiologies in our support (what we are doing).
Time study:
Study on patient records being passed on to the emergency 12 months out with a diagnosis of rhabdomyolysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with rhabdomyolysis admitted to the emergency department of the Hôpitel paris saint joseph
Key inclusion criteria (1 listed)
- All adults with CPK greater than 5N or 500 IU / L in sera to emergencies
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of change of patient complication by answering a questionary
Time frame: Hour 0, Hour 48
Detect the most common complications of Hour 0 support and evolution Hour 48 if the patient not transferred. Hour 0 support and evolution at Hour 48
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhabdomyolysis, run by Fondation Hôpital Saint-Joseph at 1 site 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Assessment of change of patient complication by answering a questionary (time frame: Hour 0, Hour 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2018.