Trial Outcomes & Findings for The Effect of Thiamine vs. Placebo on VO2 in Critical Illness (NCT NCT01985685)

NCT ID: NCT01985685

Last Updated: 2017-10-02

Results Overview

The primary outcome will be the change in VO2 over the 6 hours after administration of the study medication, adjusted for baseline VO2.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 66 participants
• Primary outcome timeframe: 6 hrs
• Results posted on: 2017-10-02

Participant Flow

Participant milestones

Measure	Thiamine 200mg intravenous thiamine in 50ml 5% dextrose, single dose Thiamine: 200 mg IV thiamine	Placebo 50ml intravenous 5% dextrose, single dose Thiamine: 200 mg IV thiamine
Overall Study STARTED	27	29
Overall Study COMPLETED	27	29
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Thiamine vs. Placebo on VO2 in Critical Illness

Baseline characteristics by cohort

Measure	Thiamine n=29 Participants 200mg intravenous thiamine in 50ml 5% dextrose, single dose Thiamine: 200 mg IV thiamine	Placebo n=27 Participants 50ml intravenous 5% dextrose, single dose Thiamine: 200 mg IV thiamine	Total n=56 Participants Total of all reporting groups
Age, Continuous	70 years n=93 Participants	66 years n=4 Participants	67 years n=27 Participants
Sex: Female, Male Female	14 Participants n=93 Participants	12 Participants n=4 Participants	26 Participants n=27 Participants
Sex: Female, Male Male	15 Participants n=93 Participants	15 Participants n=4 Participants	30 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) White	25 Participants n=93 Participants	20 Participants n=4 Participants	45 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants

PRIMARY outcome

Timeframe: 6 hrs

The primary outcome will be the change in VO2 over the 6 hours after administration of the study medication, adjusted for baseline VO2.

Outcome measures

Measure	Thiamine n=29 Participants 200mg intravenous thiamine in 50ml 5% dextrose, single dose Thiamine: 200 mg IV thiamine	Placebo n=27 Participants 50ml intravenous 5% dextrose, single dose Thiamine: 200 mg IV thiamine
Change in VO2 Over Time	4.2 ml/kg/min Interval 3.7 to 5.7	4.3 ml/kg/min Interval 3.5 to 5.3

SECONDARY outcome

Timeframe: 6 hrs

Percentage change in serum lactate

Outcome measures

Measure	Thiamine n=29 Participants 200mg intravenous thiamine in 50ml 5% dextrose, single dose Thiamine: 200 mg IV thiamine	Placebo n=27 Participants 50ml intravenous 5% dextrose, single dose Thiamine: 200 mg IV thiamine
Percentage Change in Serum Lactate	-9 percentage change Interval -17.0 to 10.0	-8 percentage change Interval -21.0 to 9.0

SECONDARY outcome

Timeframe: 6 hrs

Change in central venous oxygen saturation

Outcome measures

Measure	Thiamine n=29 Participants 200mg intravenous thiamine in 50ml 5% dextrose, single dose Thiamine: 200 mg IV thiamine	Placebo n=27 Participants 50ml intravenous 5% dextrose, single dose Thiamine: 200 mg IV thiamine
Change in Central Venous Oxygen Saturation	0 percent Interval -5.0 to 7.0	3 percent Interval -4.0 to 4.0

Adverse Events

Thiamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 9 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Katherine Berg

Beth Israel Deaconess Medical Center

Phone: 617-667-5864

Results disclosure agreements

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