- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02896517
Support for the Rhabdomyolysis in an Emergency Department (RHABDURGENCE)
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.
Study Overview
Status
Conditions
Detailed Description
Main objective / secondary:
Evaluation of current professional practice:
I. 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 Type
Contacts and Locations
Study Locations
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Ile-de-France
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Paris, Ile-de-France, France, 75014
- Groupe hospitalier Paris Saint Joseph
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All adults with CPK greater than 5N or 500 IU / L in sera to emergencies
Exclusion Criteria:
- No exclusion criteria
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Hour 0, Hour 48
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RHABDURGENCE
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