Trial Outcomes & Findings for Non-steroidal Anti-inflammatory Affect on Kidneys in Endurance Distances (NCT NCT02272725)

Results Overview

The participants experiencing acute kidney injury (diagnosed by an increase in creatinine of greater or equal to 1.5x that of estimated baseline creatinine from age and weight) will be from measured point-of-care blood test of the finish line immediately following the completion of a 50 mile ultramarathon. This outcome measure is a biochemical reading, that may not necessarily be a clinical adverse event.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

91 participants

Primary outcome timeframe

participants will be followed through the duration of a 50 mile ultramarathon, an expected average of 18 hours

Results posted on

2018-12-12

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo tasteless and inert tablets Placebo: Tasteless and inert visually identical (to ibuprofen) pills	Ibuprofen Each tablet containing 400mg of ibuprofen Ibuprofen: Ibuprofen
Overall Study STARTED	49	42
Overall Study COMPLETED	47	42
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo tasteless and inert tablets Placebo: Tasteless and inert visually identical (to ibuprofen) pills	Ibuprofen Each tablet containing 400mg of ibuprofen Ibuprofen: Ibuprofen
Overall Study equipment malfunction	2	0

Baseline Characteristics

Non-steroidal Anti-inflammatory Affect on Kidneys in Endurance Distances

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=47 Participants tasteless and inert tablets Placebo: Tasteless and inert visually identical (to ibuprofen) pills	Ibuprofen n=42 Participants Each tablet containing 400mg of ibuprofen Ibuprofen: Ibuprofen	Total n=89 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	47 Participants n=5 Participants	42 Participants n=7 Participants	89 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	42 years STANDARD_DEVIATION 10.5 • n=5 Participants	40 years STANDARD_DEVIATION 7.1 • n=7 Participants	41 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	33 Participants n=7 Participants	67 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Creatinine	0.83 mg/dL STANDARD_DEVIATION 0.1 • n=5 Participants	0.83 mg/dL STANDARD_DEVIATION 0.1 • n=7 Participants	0.83 mg/dL STANDARD_DEVIATION 0.1 • n=5 Participants

PRIMARY outcome

Timeframe: participants will be followed through the duration of a 50 mile ultramarathon, an expected average of 18 hours

The participants experiencing acute kidney injury (diagnosed by an increase in creatinine of greater or equal to 1.5x that of estimated baseline creatinine from age and weight) will be from measured point-of-care blood test of the finish line immediately following the completion of a 50 mile ultramarathon. This outcome measure is a biochemical reading, that may not necessarily be a clinical adverse event.

Outcome measures

Outcome measures
Measure	Placebo n=47 Participants tasteless and inert tablets Placebo: Tasteless and inert visually identical (to ibuprofen) pills	Ibuprofen n=42 Participants Each tablet containing 400mg of ibuprofen Ibuprofen: Ibuprofen
Acute Kidney Injury	16 Participants	22 Participants

SECONDARY outcome

Timeframe: participants will be followed through the duration of a 50 mile ultramarathon, an expected average of 18 hours

A Borg score of perceived exertion will be measured at the finish line immediately following completion of a 50 mile ultramarathon to measure what affect ibuprofen had on perceived exertion as analgesia may have made the endurance event perceived as less exertional. Scores range from 7 - 20, with higher scores indicative of greater amount of exertion.

Outcome measures

Outcome measures
Measure	Placebo n=47 Participants tasteless and inert tablets Placebo: Tasteless and inert visually identical (to ibuprofen) pills	Ibuprofen n=42 Participants Each tablet containing 400mg of ibuprofen Ibuprofen: Ibuprofen
Perceived Exertion	15.96 units on a scale Standard Deviation 2.6	15.99 units on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: participants will be followed through the duration of a 50 mile ultramarathon, an expected average of 18 hours

The count of participants experiencing exercise-associated hyponatremia (defined as \< 135 mEq) will be estimated from measured point-of-care blood test at the finish line immediately following completion of a 50 mile ultramarathon. This outcome measure is a biochemical reading, that may not necessarily be a clinical adverse event.

Outcome measures

Outcome measures
Measure	Placebo n=47 Participants tasteless and inert tablets Placebo: Tasteless and inert visually identical (to ibuprofen) pills	Ibuprofen n=42 Participants Each tablet containing 400mg of ibuprofen Ibuprofen: Ibuprofen
Exercise-Associated Hyponatremia	7 Participants	3 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ibuprofen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Grant Lipman

Stanford University School of Medicine

Phone: 415-290-9286

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place