Evaluation of the Renal Function in an Ultra-endurance Race.

NCT ID: NCT03136315

Last Updated: 2017-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-07

Study Completion Date

2017-09-10

Brief Summary

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During ultra endurance events, athletes experience extreme physical and mental demands, sometimes at the limits of the adaptive response to human physiology. This is particularly true for the renal function, and some evidence for acute renal failure has already been shown, sometimes leading to dialysis. However, the precise mechanisms involved in acute renal failure in such ultra endurance races are not clearly elucidated.

The aim of our study is to estimate glomerular filtration rate from serum and urinary creatinine and cystitin C at the beginning and at the end of a 110 km ultra endurance race. Our hypothesis is that during the ultra endurance race, renal function may be injured, with a risk for the athlete.

Detailed Description

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Conditions

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Renal Insufficiency, Acute

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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INFERNAL Arm

The INFERNAL Arm will have serum and urinary dosage for creatinine and cystanin C at the beginning and at the end of the 110 km race.

Group Type EXPERIMENTAL

INFERNAL Intervention

Intervention Type OTHER

The intervention consists in serum and urinary dosage (creatinine and Cystatin C) at the beginning and the end of the 110 km race.

Interventions

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INFERNAL Intervention

The intervention consists in serum and urinary dosage (creatinine and Cystatin C) at the beginning and the end of the 110 km race.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age: At least 20 years old
* Athlete that is officially registered to the 110 km race (INFERNAL Trail des Vosges)
* Athlete informed by a member (MD) of the Medical Staff of the race.
* Athlete that gives and signes the informed consent to the research protocol

Exclusion Criteria

* Athlete with a known disease that needs the following medications:
* Medications influencing the renin-angiotensin-aldosteron system (angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, aldosteron receptor blockers)
* Diuretic drugs
* Anticoagulant drugs
* Non-steroidal anti-inflammatory drugs
* Athlete with a known thyroid disease (because of the influence on the serum cystatin level)
* Athlete with a know renal disease
* Athlete with a know inflammatory disease
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Stade des Perrey

Saint-Nabord, Lorraine, France

Site Status

Countries

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France

References

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Didier S, Vauthier JC, Gambier N, Renaud P, Chenuel B, Poussel M. Substance use and misuse in a mountain ultramarathon: new insight into ultrarunners population? Res Sports Med. 2017 Apr-Jun;25(2):244-251. doi: 10.1080/15438627.2017.1282356. Epub 2017 Jan 23.

Reference Type BACKGROUND
PMID: 28114830 (View on PubMed)

Poussel M, Vauthier JC, Renaud P, Gambier N, Chenuel B, Ladriere M. [Acute kidney injury following naproxene use in an ultraendurance female athlete]. Presse Med. 2013 Sep;42(9 Pt 1):1274-6. doi: 10.1016/j.lpm.2012.09.030. Epub 2013 Feb 27. No abstract available. French.

Reference Type BACKGROUND
PMID: 23453505 (View on PubMed)

Hoffman MD, Weiss RH. Does Acute Kidney Injury From an Ultramarathon Increase the Risk for Greater Subsequent Injury? Clin J Sport Med. 2016 Sep;26(5):417-22. doi: 10.1097/JSM.0000000000000277.

Reference Type BACKGROUND
PMID: 26657822 (View on PubMed)

Hoffman MD, Stuempfle KJ, Fogard K, Hew-Butler T, Winger J, Weiss RH. Urine dipstick analysis for identification of runners susceptible to acute kidney injury following an ultramarathon. J Sports Sci. 2013;31(1):20-31. doi: 10.1080/02640414.2012.720705. Epub 2012 Oct 4.

Reference Type BACKGROUND
PMID: 23035796 (View on PubMed)

Other Identifiers

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2017-A00808-45

Identifier Type: -

Identifier Source: org_study_id

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