Renal Insufficiency, AcuteINFERNALNCT03136315
Evaluation of the Renal Function in an Ultra-endurance Race.
A study testing INFERNAL Intervention in people with Renal Insufficiency, Acute, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency, Acute
- What is being tested?
- INFERNAL Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 7 Sep 2017to 10 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Renal Insufficiency, Acute
- Being tested
- INFERNAL Intervention
- Keywords
- Renal failure, athlete, ultra endurance
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INFERNAL InterventionOther
The intervention consists in serum and urinary dosage (creatinine and Cystatin C) at the beginning and the end of the 110 km race.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: INFERNAL Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular filtration rate
The glomerular filtration rate will be calculated from the serum and urinary creatinine and cystatin C dosage
Measured: 30 minutes at baseline (09.07.2017), and 30 minutes at the end of the 110 km race (2 or 3 days after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start7 Sep 2017
- Primary completion10 Sep 2017
- Study completion10 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Renal Insufficiency, AcuteStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136315
- Sponsor's protocol ID
- 2017-A00808-45
- Acronym
- INFERNAL
- Status last verified
- Apr 2017
- First submitted
- 21 Apr 2017
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28114830Poussel 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.
PubMed 23453505Hoffman 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.
PubMed 26657822Hoffman 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.
PubMed 23035796
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Function Evaluation in an Ultra Endurance Race: On the Interest of Monitoring Specific Biomarkers to Asses Renal Risk.
- ClinicalTrials.gov ID
- NCT03136315
- Acronym / sponsor ID
- INFERNAL / 2017-A00808-45
- Conditions
- Renal Insufficiency, Acute
- Keywords
- Renal failure, athlete, ultra endurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 10 Sep 2017 (actual)
- Study completion
- 10 Sep 2017 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INFERNAL Arm | Experimental | Other: INFERNAL InterventionThe 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INFERNAL InterventionThe intervention consists in serum and urinary dosage (creatinine and Cystatin C) at the beginning and the end of the 110 km race. | Other | INFERNAL Arm |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- Background: PubMed 28114830Didier 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.
- Background: PubMed 23453505Poussel 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.
- Background: PubMed 26657822Hoffman 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.
- Background: PubMed 23035796Hoffman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INFERNAL Intervention in people with Renal Insufficiency, Acute, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03136315, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2017.