Support for the Rhabdomyolysis in an Emergency Department

Rhabdomyolysis Clinical Trial

— RHABDURGENCE  

Official title:

Support for the Rhabdomyolysis in an Emergency Department

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02896517
• Other study ID #: RHABDURGENCE
• Status: Withdrawn
• Start date: October 1, 2016
• Est. completion date: October 1, 2016

Study information

• Verified date: August 2018
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 1, 2016
• Est. primary completion date: October 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All adults with CPK greater than 5N or 500 IU / L in sera to emergencies

Exclusion Criteria:

• No exclusion criteria

Related Conditions & MeSH terms

• Emergencies
• Rhabdomyolysis

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hour 0, Hour 48