Trial Outcomes & Findings for Effect of Thiamine on Oxygen Utilization (VO2) in Critical Illness (NCT NCT01462279)

Last Updated: 2018-01-16

Results Overview

VO2 measurements are taken at baseline and VO2 is continuously monitored over 9 hours. Thiamine is administered three hours after baseline measurements are taken.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

Baseline to 9 Hours

Results posted on

2018-01-16

Participant Flow

Participant milestones

Participant milestones
Measure	Thiamine Open label - 200mg IV Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once
Overall Study STARTED	20
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Thiamine on Oxygen Utilization (VO2) in Critical Illness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Thiamine n=17 Participants Open label - 200mg IV Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Age, Continuous	66 years STANDARD_DEVIATION 17 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 9 Hours

VO2 measurements are taken at baseline and VO2 is continuously monitored over 9 hours. Thiamine is administered three hours after baseline measurements are taken.

Outcome measures

Outcome measures
Measure	Thiamine n=17 Participants Open label - 200mg IV Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once
Improvement in VO2	16.9 ml/min Standard Deviation 8.6

SECONDARY outcome

Timeframe: Baseline to Nine Hours

Population: Due to the single-arm nature and small size of the study, and with no comparison arm, we did not think we had the statistical power to evaluate for a change in hemodynamics so this was not a planned outcome and was entered in error.

Hemodynamics were collected in all patients but we did not evaluate change in hemodynamics over the 9 hour protocol of the study. Due to the single-arm nature and small size of the study, and with no comparison arm, we did not think we had the statistical power to evaluate for a change in hemodynamics so this was not a planned outcome and was entered in error.

Outcome measures

Outcome data not reported

Adverse Events

Thiamine

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. Michael W. Donnino

Beth Israel Deaconess Medical Center

Phone: 6177542341

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place