Trial Outcomes & Findings for Thiamine as a Metabolic Resuscitator in Septic Shock (NCT NCT01070810)
NCT ID: NCT01070810
Last Updated: 2017-05-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
88 participants
Primary outcome timeframe
24 hours
Results posted on
2017-05-15
Participant Flow
Participant milestones
| Measure |
Placebo
50 ml D5W
D5W: Dextrose 5%
|
Thiamine
200mg Thiamine in 50ml D5W
Thiamine: Thiamine 200mg in 50ml Dextrose 5%
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
43
|
|
Overall Study
COMPLETED
|
45
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Thiamine as a Metabolic Resuscitator in Septic Shock
Baseline characteristics by cohort
| Measure |
Placebo
n=45 Participants
50 ml D5W D5W: Dextrose 5%
|
Thiamine
n=43 Participants
200mg Thiamine in 50ml D5W Thiamine: Thiamine 200mg in 50ml Dextrose 5%
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 17 • n=99 Participants
|
70 years
STANDARD_DEVIATION 14 • n=107 Participants
|
67 years
STANDARD_DEVIATION 16 • n=206 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=99 Participants
|
43 participants
n=107 Participants
|
88 participants
n=206 Participants
|
|
BMI
|
29 kg/m^2
STANDARD_DEVIATION 7 • n=99 Participants
|
29 kg/m^2
STANDARD_DEVIATION 9 • n=107 Participants
|
29 kg/m^2
STANDARD_DEVIATION 8 • n=206 Participants
|
PRIMARY outcome
Timeframe: 24 hoursOutcome measures
| Measure |
Placebo
n=45 Participants
50 ml D5W
D5W: Dextrose 5%
|
Thiamine
n=43 Participants
200mg Thiamine in 50ml D5W
Thiamine: Thiamine 200mg in 50ml Dextrose 5%
|
|---|---|---|
|
Lactate Level 24 Hours After the First Study Medication Dose
|
2.6 mmol/L
Interval 1.6 to 5.1
|
2.5 mmol/L
Interval 1.5 to 3.4
|
SECONDARY outcome
Timeframe: Hospital stay, average 2 weeksShock reversal was defined as \> 24 hours off all vasopressors
Outcome measures
| Measure |
Placebo
n=45 Participants
50 ml D5W
D5W: Dextrose 5%
|
Thiamine
n=43 Participants
200mg Thiamine in 50ml D5W
Thiamine: Thiamine 200mg in 50ml Dextrose 5%
|
|---|---|---|
|
Number of Participants With Shock Reversal
|
32 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: APACHE II was not available on 6 patients in each group at 24 hour mostly because of early death.
APACHE II ("Acute Physiology and Chronic Health Evaluation II") is a severity-of-disease classification system; an integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death
Outcome measures
| Measure |
Placebo
n=39 Participants
50 ml D5W
D5W: Dextrose 5%
|
Thiamine
n=37 Participants
200mg Thiamine in 50ml D5W
Thiamine: Thiamine 200mg in 50ml Dextrose 5%
|
|---|---|---|
|
APACHE II Score at 24 Hours
|
26 units on a scale
Standard Deviation 10
|
23 units on a scale
Standard Deviation 8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hoursBaseline thiamine deficiency was defined as a baseline thiamine level of ≤ 7 nmol/L
Outcome measures
| Measure |
Placebo
n=15 Participants
50 ml D5W
D5W: Dextrose 5%
|
Thiamine
n=13 Participants
200mg Thiamine in 50ml D5W
Thiamine: Thiamine 200mg in 50ml Dextrose 5%
|
|---|---|---|
|
Lactate Level at 24 Hours in Patients With Baseline Thiamine Deficiency
|
2.1 nmol/L
Interval 1.4 to 2.5
|
3.1 nmol/L
Interval 1.9 to 8.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Hospital stay, average 2 weeksBaseline thiamine deficiency was defined as a baseline thiamine level of ≤ 7 nmol/L
Outcome measures
| Measure |
Placebo
n=15 Participants
50 ml D5W
D5W: Dextrose 5%
|
Thiamine
n=13 Participants
200mg Thiamine in 50ml D5W
Thiamine: Thiamine 200mg in 50ml Dextrose 5%
|
|---|---|---|
|
Number of Participants Dying Before Hospital Discharge in Patients With Baseline Thiamine Deficiency
|
2 Participants
|
6 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 19 deaths
Thiamine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 19 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place