Clinical trial NCT03136315: Evaluation of the Renal Function in an Ultra-endurance Race.
Official title: Renal Function Evaluation in an Ultra Endurance Race: On the Interest of Monitoring Specific Biomarkers to Asses Renal Risk.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Insufficiency, Acute
Keywords: Renal failure
athlete
ultra endurance
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-05-02
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Glomerular filtration rate
timeFrame: 30 minutes at baseline (09.07.2017), and 30 minutes at the end of the 110 km race (2 or 3 days after baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Nabord
country: France
facility: Stade des Perrey
state: Lorraine
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.