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

September 11, 2017 updated by: Central Hospital, Nancy, France

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Lorraine
      • Saint Nabord, Lorraine, France, 88200
        • Stade des Perrey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: INFERNAL Arm
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
The intervention consists in serum and urinary dosage (creatinine and Cystatin C) at the beginning and the end of the 110 km race.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 minutes at baseline (09.07.2017), and 30 minutes at the end of the 110 km race (2 or 3 days after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 7, 2017

Primary Completion (ACTUAL)

September 10, 2017

Study Completion (ACTUAL)

September 10, 2017

Study Registration Dates

First Submitted

April 21, 2017

First Submitted That Met QC Criteria

April 27, 2017

First Posted (ACTUAL)

May 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 12, 2017

Last Update Submitted That Met QC Criteria

September 11, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-A00808-45

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Renal Insufficiency, Acute

Clinical Trials on INFERNAL Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe