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

Primary Purpose

Renal Insufficiency, Acute

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
INFERNAL Intervention
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Renal Insufficiency, Acute focused on measuring Renal failure, athlete, ultra endurance

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Stade des Perrey

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

INFERNAL Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 21, 2017
Last Updated
September 11, 2017
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT03136315
Brief Title
Evaluation of the Renal Function in an Ultra-endurance Race.
Acronym
INFERNAL
Official Title
Renal Function Evaluation in an Ultra Endurance Race: On the Interest of Monitoring Specific Biomarkers to Asses Renal Risk.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 7, 2017 (Actual)
Primary Completion Date
September 10, 2017 (Actual)
Study Completion Date
September 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Acute
Keywords
Renal failure, athlete, ultra endurance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
INFERNAL Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
INFERNAL Intervention
Intervention Description
The intervention consists in serum and urinary dosage (creatinine and Cystatin C) at the beginning and the end of the 110 km race.
Primary Outcome Measure Information:
Title
Glomerular filtration rate
Description
The glomerular filtration rate will be calculated from the serum and urinary creatinine and cystatin C dosage
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Stade des Perrey
City
Saint Nabord
State/Province
Lorraine
ZIP/Postal Code
88200
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28114830
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.
Results Reference
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PubMed Identifier
23453505
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.
Results Reference
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PubMed Identifier
26657822
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.
Results Reference
background
PubMed Identifier
23035796
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.
Results Reference
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Evaluation of the Renal Function in an Ultra-endurance Race.

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