Trial Outcomes & Findings for Acetyl-L-Carnitine in the Treatment of Septic Shock (NCT NCT00592488)

NCT ID: NCT00592488

Last Updated: 2017-12-08

Results Overview

Mean Arterial blood pressure measured non-invasively at 18 hours

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 13 participants
• Primary outcome timeframe: 18 hours
• Results posted on: 2017-12-08

Participant Flow

Participant milestones

Measure	Placebo Then ALC Placebo for first 6 hours then ALC for 12 hours	ALC Then Placebo ALC for first 12 hours then placebo for next 6 hours
Overall Study STARTED	6	7
Overall Study COMPLETED	6	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acetyl-L-Carnitine in the Treatment of Septic Shock

Baseline characteristics by cohort

Measure	Placebo Then ALC n=6 Participants Placebo for first 6 hours then ALC for 12 hours	ALC Then Placebo n=7 Participants ALC for first 12 hours then placebo for next 6 hours	Total n=13 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	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	7 participants n=7 Participants	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 hours

Population: All patients treated. Intention to treat.

Mean Arterial blood pressure measured non-invasively at 18 hours

Outcome measures

Measure	Acetyl-L-Carnitine (ALC) Then Placebo n=7 Participants ALC for hours 0-12 and placebo hours 12-18	Placebo Then Acetyl-L-Carnitine (ALC) n=6 Participants Placebo for hours 0-6 then ALC for hours 6-18
Mean Arterial Blood Pressure	60 mm Hg Standard Error 3	60 mm Hg Standard Error 4

SECONDARY outcome

Timeframe: 6-24 hours

Change in vasopressor dose between 6 and 24 hours.

Outcome measures

Measure	Acetyl-L-Carnitine (ALC) Then Placebo n=7 Participants ALC for hours 0-12 and placebo hours 12-18	Placebo Then Acetyl-L-Carnitine (ALC) n=6 Participants Placebo for hours 0-6 then ALC for hours 6-18
Vasopressor Dose	-1.4 mcg/kg/min Standard Deviation 4.4	-4.8 mcg/kg/min Standard Deviation 5.9

SECONDARY outcome

Timeframe: 12-36 hours

Latest serum lactate between 12 and 36 hours

Outcome measures

Measure	Acetyl-L-Carnitine (ALC) Then Placebo n=7 Participants ALC for hours 0-12 and placebo hours 12-18	Placebo Then Acetyl-L-Carnitine (ALC) n=6 Participants Placebo for hours 0-6 then ALC for hours 6-18
Serum Lactate	2.1 mg/dL Standard Deviation 1.7	2.0 mg/dL Standard Deviation 1.8

Adverse Events

Placebo Then ALC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ALC Then Placebo

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

Todd Rice, MD

Vanderbilt University

Phone: 615 322-3412

Email: todd.rice@vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place