Trial Outcomes & Findings for Pilot Study of the Safety of a Daily Ethanol Lock for Urinary Catheters in Critically Ill Children (NCT NCT01865708)

Results Overview

An ethanol lock, utilizing 74% ethanol, will begin within 24 hours of catheter placement. The lock will be done every 24 hours for 1 hour. Blood alcohol levels will be obtained every day, approximately 1 hour after ethanol lock release, for 3 days: at baseline, 1 day post catheter placement, 2 days post catheter placement, and 3 days post catheter placement. Number of participants with Blood Alcohol Levels exceeding 10 mg/100 ml on any study day was analyzed.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

10 participants

Primary outcome timeframe

up to 3 days

Results posted on

2018-06-28

Participant Flow

Participant milestones

Participant milestones
Measure	Ethanol Lock 74% Ethanol lock will begin within 24 hours of urinary catheter placement. Lock will be done every 24 hours for 1 hour. The volume that will be instilled depends upon the fill volume of the catheter, which is imprinted by the manufacturer on each catheter. Once the alcohol is in the catheter, the proximal end of the catheter will be clamped for 1 hour. After 1 hour dwell time, the clamp will be removed and catheter will be flushed out by the patient's own urine output.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study of the Safety of a Daily Ethanol Lock for Urinary Catheters in Critically Ill Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ethanol Lock n=10 Participants 74% Ethanol lock will begin within 24 hours of urinary catheter placement. Lock will be done every 24 hours for 1 hour. The volume that will be instilled depends upon the fill volume of the catheter, which is imprinted by the manufacturer on each catheter. Once the alcohol is in the catheter, the proximal end of the catheter will be clamped for 1 hour. After 1 hour dwell time, the clamp will be removed and catheter will be flushed out by the patient's own urine output.
Age, Continuous	6.7 years STANDARD_DEVIATION 4.5 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 3 days

Population: Number of patients with detectable blood alcohol level, defined as \>= 10 mg/dL.

An ethanol lock, utilizing 74% ethanol, will begin within 24 hours of catheter placement. The lock will be done every 24 hours for 1 hour. Blood alcohol levels will be obtained every day, approximately 1 hour after ethanol lock release, for 3 days: at baseline, 1 day post catheter placement, 2 days post catheter placement, and 3 days post catheter placement. Number of participants with Blood Alcohol Levels exceeding 10 mg/100 ml on any study day was analyzed.

Outcome measures

Outcome measures
Measure	Ethanol Lock n=10 Participants 74% Ethanol lock will begin within 24 hours of urinary catheter placement. Lock will be done every 24 hours for 1 hour. The volume that will be instilled depends upon the fill volume of the catheter, which is imprinted by the manufacturer on each catheter. Once the alcohol is in the catheter, the proximal end of the catheter will be clamped for 1 hour. After 1 hour dwell time, the clamp will be removed and catheter will be flushed out by the patient's own urine output.
Blood Alcohol Level	0 Participants

SECONDARY outcome

Timeframe: Data shown is the mean increase in red blood cells per high powered field after ethanol instillation averaged across all post-EL days and all patients compared to the mean baseline red blood cells per high powered field in urinalysis prior to any EL.

Population: Change in detectable red blood cells per high powered field in urinalysis. Data shown is the mean increase in red blood cells per high powered field after ethanol instillation averaged across all post-EL days and all patients compared to the mean baseline red blood cells per high powered field in urinalysis prior to any EL.

An ethanol lock, utilizing 74% ethanol, will begin within 24 hours of catheter placement. The lock will be done every 24 hours for 1 hour, for a total of 3 days. A baseline urinalysis will be obtained prior to the first instillation of ethanol, looking for hematuria. A urinalysis will be obtained approximately 1 hour after the lock is released. Data shown is the mean increase in red blood cells per high powered field after ethanol instillation averaged across all post-ethanol lock days and all patients compared to the mean baseline red blood cells per high powered field in urinalysis prior to any ethanol lock.

Outcome measures

Outcome measures
Measure	Ethanol Lock n=10 Participants 74% Ethanol lock will begin within 24 hours of urinary catheter placement. Lock will be done every 24 hours for 1 hour. The volume that will be instilled depends upon the fill volume of the catheter, which is imprinted by the manufacturer on each catheter. Once the alcohol is in the catheter, the proximal end of the catheter will be clamped for 1 hour. After 1 hour dwell time, the clamp will be removed and catheter will be flushed out by the patient's own urine output.
Urine Analysis	90.1 red blood cells per high powered field Standard Deviation 226.4

Adverse Events

Ethanol Lock

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ethanol Lock n=10 participants at risk 74% Ethanol lock will begin within 24 hours of urinary catheter placement. Lock will be done every 24 hours for 1 hour. The volume that will be instilled depends upon the fill volume of the catheter, which is imprinted by the manufacturer on each catheter. Once the alcohol is in the catheter, the proximal end of the catheter will be clamped for 1 hour. After 1 hour dwell time, the clamp will be removed and catheter will be flushed out by the patient's own urine output.
Renal and urinary disorders Microscopic hematuria	40.0% 4/10 • Number of events 5

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jana Stockwell

Children's Healthcare of Atlanta

Phone: 404-785-1868

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place