Thiamine as a Metabolic Resuscitator in Septic Shock

Beth Israel Lahey Health

Status and phase: Completed; Phase 2; Phase 1

Conditions: Septic Shock

Treatments: Drug: D5W; Drug: Thiamine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01070810

2008P000053

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Greater than 18 years old
• Suspected or confirmed source of infection
• Hypotension (systolic pressure <90 mmHg) after a minimum 2 liter fluid bolus followed by vasopressor-dependence.
• Lactic Acidosis > 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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88 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

50 ml D5W

Treatment:

Drug: D5W

2

Experimental group

Description:

200mg Thiamine in 50ml D5W

Treatment:

Drug: Thiamine