Thiamine as a Metabolic Resuscitator in Septic Shock

Septic Shock Clinical Trial

Official title:

Thiamine as a Metabolic Resuscitator in Septic Shock

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01070810
• Other study ID #: 2008P-000053
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 17, 2010
• Last updated: September 3, 2015
• Start date: February 2010
• Est. completion date: November 2014

Study information

• Verified date: September 2015
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• D5W
Dextrose 5%
• Thiamine
Thiamine 200mg in 50ml Dextrose 5%

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Lactate from time of study drug (or placebo) administration over 24 hours post delivery		24 hours	No
Secondary	Time to shock reversal		7 days	No
Secondary	Reduction of APACHE II Score		24 hours	No