NCT02896517

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
19 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

Same day

First QC Date

August 31, 2016

Last Update Submit

August 9, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with rhabdomyolysis admitted to the emergency department of the Hôpitel paris saint joseph

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Rhabdomyolysis

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2016

First Posted

September 12, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

August 13, 2018

Record last verified: 2018-08

Locations