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Completed

NCT Number: NCT03136315

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stade des Perrey

Saint-Nabord, Lorraine, 88200, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Glomerular filtration rate

    Time frame: 30 minutes at baseline (09.07.2017), and 30 minutes at the end of the 110 km race (2 or 3 days after baseline)

    The glomerular filtration rate will be calculated from the serum and urinary creatinine and cystatin C dosage

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: INFERNAL

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 2, 2017
Registry last updated
Sep 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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