Phase 2
N=88
Thiamine as a Metabolic Resuscitator in Septic Shock
Septic Shock
Bottom Line
View on ClinicalTrials.gov: NCT01070810 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Lactate Level 24 Hours After the First Study Medication Dose — 2.6; 2.5 mmol/L — p=0.40
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- D5W (Drug); Thiamine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lactate Level 24 Hours After the First Study Medication Dose |
2.6; 2.5 | 0.40 |
| SECONDARY Number of Participants With Shock Reversal |
32; 32 | 0.97 |
| SECONDARY APACHE II Score at 24 Hours |
26; 23 | 0.15 |
Summary
The major goal of this project is to determine whether the use of thiamine in patients with septic shock will result in attenuation of lactic acidosis and a more rapid reversal of shock.
Eligibility Criteria
Inclusion Criteria
- Greater than 18 years old
- Suspected or confirmed source of infection
- Hypotension (systolic pressure 3 mmol/dl
Exclusion Criteria
- Competing cause of lactic acidosis including: seizures within 3 hours of enrollment, use of linazolid metformin or anti-retrovirals at the time of enrollment, carbon monoxide or cyanide poisoning, highly suspected or known ischemic bowel, and known mitochondrial disorders
- Liver dysfunction specifically defined as AST or ALT elevation greater than 240
- Current Thiamine supplements or usage
- Competing indication for thiamine administration
- Cardiac Arrest
- DNR/DNI or comfort care status (DNR status in an intubated patient receiving full care is eligible)
Data sourced from ClinicalTrials.gov (NCT01070810). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.