Trial Outcomes & Findings for Evaluation of Post-Exposure Sauna Treatment of Firefighters - A Pilot Study (NCT NCT03429348)
NCT ID: NCT03429348
Last Updated: 2021-02-05
Results Overview
Urine samples from firefighters post-fire will be measured for hydroxylated PAHs (PAH-OHs) and the concentration compared to pre-fire urine concentrations of PAH-OHs
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
12 hours for urine collection
Results posted on
2021-02-05
Participant Flow
Participant milestones
| Measure |
No Additional Rehabilitation
No additional rehabilitation will be done
|
Sauna Rehabilitation
An additional rehabilitation in a sauna will be done
Sauna Rehabilitation: Firefighters selected for sauna rehabilitation will spend time in a sauna
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Post-Exposure Sauna Treatment of Firefighters - A Pilot Study
Baseline characteristics by cohort
| Measure |
No Additional Rehabilitation
n=12 Participants
No additional rehabilitation will be done
|
Sauna Rehabilitation
n=12 Participants
An additional rehabilitation in a sauna will be done
Sauna Rehabilitation: Firefighters selected for sauna rehabilitation will spend time in a sauna
|
Total
n=24 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
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Urinary PAH-OHs
|
10364.2 ng/L
STANDARD_DEVIATION 2.7 • n=5 Participants
|
6964.1 ng/L
STANDARD_DEVIATION 1.7 • n=7 Participants
|
8495.7 ng/L
STANDARD_DEVIATION 2.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 hours for urine collectionUrine samples from firefighters post-fire will be measured for hydroxylated PAHs (PAH-OHs) and the concentration compared to pre-fire urine concentrations of PAH-OHs
Outcome measures
| Measure |
Baseline No Additional Rehabilitation Group Urine PAH-OH Sum
n=12 Participants
Urine samples were analyzed for PAH-OHs The derivatized extracts were analyzed with gas chromatography mass spectroscopy (GC-MS). The sum of the PAH-OHs was determined for the baseline control group samples.
|
Post-fire No Additional Rehabilitation Group
n=12 Participants
Urine samples were analyzed for PAH-OHs The derivatized extracts were analyzed on a GC-MS. The sum of the PAH-OHs was determined for the post-fire samples for the control group.
|
Baseline Sauna Rehabilitation Group Urine PAH-OH Sum
n=12 Participants
Urine samples were analyzed for PAH-OHs The derivatized extracts were analyzed on a GC-MS. The sum of the PAH-OHs was determined for the baseline sauna group.
|
Post-fire Sauna Rehabilitation Group
n=12 Participants
Urine samples were analyzed for PAH-OHs The derivatized extracts were analyzed on a GC-MS. The sum of the PAH-OHs was determined for the post-fire sauna group.
|
|---|---|---|---|---|
|
Urinary Excretion of Hydroxylated PAHs (PAH-OHs)
|
10364.2 ng/L
Standard Deviation 2.7
|
40012.1 ng/L
Standard Deviation 2.6
|
6964.1 ng/L
Standard Deviation 1.7
|
22604.3 ng/L
Standard Deviation 1.6
|
Adverse Events
No Additional Rehabilitation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sauna Rehabilitation
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
Jeff Burgess, MD., MS, MPH, Assoc Dean of Research
University of Arizona
Phone: 520-626-4918
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place