Thiamine as a Metabolic Resuscitator in Septic Shock

Completed · Phase 1/Phase 2

Conditions studied: Septic Shock

In brief

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.

Key facts

Study ID

NCT01070810

Run by

Beth Israel Deaconess Medical Center

People needed

88

Starts

2010-02-01

Expected to finish

2014-11-01

Last updated by the study team

2017-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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