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

Renal Insufficiency, Acute Clinical Trial

— INFERNAL  

Official title:

Renal Function Evaluation in an Ultra Endurance Race: On the Interest of Monitoring Specific Biomarkers to Asses Renal Risk.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03136315
• Other study ID #: 2017-A00808-45
• Status: Completed
• Phase: N/A
• First received: April 21, 2017
• Last updated: September 11, 2017
• Start date: September 7, 2017
• Est. completion date: September 10, 2017

Study information

• Verified date: April 2017
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 10, 2017
• Est. primary completion date: September 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Renal Insufficiency
• Renal Insufficiency, Acute

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Stade des Perrey	Saint Nabord	Lorraine

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View 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. — View 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. — View Citation

Poussel M, Vauthier JC, Renaud P, Gambier N, Chenuel B, Ladrière 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. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glomerular filtration rate	The glomerular filtration rate will be calculated from the serum and urinary creatinine and cystatin C dosage	30 minutes at baseline (09.07.2017), and 30 minutes at the end of the 110 km race (2 or 3 days after baseline)