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Thiamine as a Metabolic Resuscitator in Septic Shock

This study has been completed.
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Michael Donnino, Beth Israel Deaconess Medical Center Identifier:
First received: February 17, 2010
Last updated: September 3, 2015
Last verified: September 2015
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.

Condition Intervention Phase
Septic Shock
Drug: D5W
Drug: Thiamine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Thiamine as a Metabolic Resuscitator in Septic Shock

Resource links provided by NLM:

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Change in Lactate from time of study drug (or placebo) administration over 24 hours post delivery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to shock reversal [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Reduction of APACHE II Score [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: February 2010
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
50 ml D5W
Drug: D5W
Dextrose 5%
Experimental: 2
200mg Thiamine in 50ml D5W
Drug: Thiamine
Thiamine 200mg in 50ml Dextrose 5%


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Greater than 18 years old
  • Suspected or confirmed source of infection
  • Hypotension (systolic pressure <90 mmHg) after a minimum 20-30 cc/kg 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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01070810

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Michael W Donnino, MD Beth Israel Deaconess Medical Center (BIDMC)
  More Information

Responsible Party: Michael Donnino, Michael W. Donnino, MD, Beth Israel Deaconess Medical Center Identifier: NCT01070810     History of Changes
Other Study ID Numbers: 2008P-000053 
Study First Received: February 17, 2010
Last Updated: September 3, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Beth Israel Deaconess Medical Center:
Septic Shock

Additional relevant MeSH terms:
Shock, Septic
Pathologic Processes
Systemic Inflammatory Response Syndrome
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs processed this record on January 17, 2017