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

NCT03136315 | Completed DMC

• 1 other identifier: 2017-A00808-45
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Insufficiency, Acute

Keywords

Renal failure; athlete; ultra endurance

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

INFERNAL Arm

EXPERIMENTAL

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.

Other: INFERNAL Intervention

Interventions

INFERNAL Intervention OTHER

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

INFERNAL Arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Stade des Perrey

Saint-Nabord, Lorraine, 88200, France

Location

Related 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.

  PMID: 28114830 BACKGROUND

• 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.

  PMID: 23453505 BACKGROUND

• 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.

  PMID: 26657822 BACKGROUND

• 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.

  PMID: 23035796 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: May 2, 2017
• Study Start: September 7, 2017
• Primary Completion: September 10, 2017
• Study Completion: September 10, 2017
• Last Updated: September 12, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)