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Thiamine as a Metabolic Resuscitator in Septic Shock

This study is currently recruiting participants.
Verified July 2011 by Beth Israel Deaconess Medical Center
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01070810
First received: February 17, 2010
Last updated: July 19, 2011
Last verified: July 2011
History of Changes
  Purpose

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:

MedlinePlus related topics: Sepsis Shock
U.S. FDA Resources

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 ]

Estimated Enrollment: 88
Study Start Date: February 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (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%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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-retovirals at the time of enrollment, carbon monoxide or cyanide poisoning, 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070810

Contacts
Contact: Michael W Donnino, MD 617-754-2295 mdonnino@bidmc.harvard.edu
Contact: Justin D Salciccioli 617-754-2881 jsalcicc@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Michael W Donnino, MD     617-754-2295     mdonnino@bidmc.harvard.edu    
Contact: Justin D Salciccioli     617-754-2882     ecarney@bidmc.harvard.edu    
Principal Investigator: Michael W Donnino, MD            
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institutes of Health (NIH)
National Center for Complementary and Alternative Medicine (NCCAM)
Investigators
Principal Investigator: Michael W Donnino, MD Beth Israel Deaconess Medical Center (BIDMC)
  More Information

No publications provided

Responsible Party: Michael W. Donnino, MD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01070810     History of Changes
Other Study ID Numbers: 2008P-000053
Study First Received: February 17, 2010
Last Updated: July 19, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Beth Israel Deaconess Medical Center:
Septic Shock
Sepsis

Additional relevant MeSH terms:
Thiamine
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
 Inflammation
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013