Clinical Trial: Thiamine as a Metabolic Resuscitator in Septic Shock
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Thiamine as a Metabolic Resuscitator in Septic Shock
Brief 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.
Detailed Summary:
Sponsor: Beth Israel Deaconess Medical Center
Current Primary Outcome: Lactate Level 24 Hours After the First Study Medication Dose [ Time Frame: 24 hours ]
Original Primary Outcome: Change in Lactate from time of study drug (or placebo) administration over 24 hours post delivery [ Time Frame: 24 hours ]
Current Secondary Outcome:
- Number of Participants With Shock Reversal [ Time Frame: Hospital stay, average 2 weeks ]Shock reversal was defined as > 24 hours off all vasopressors
- APACHE II Score at 24 Hours [ Time Frame: 24 hours ]APACHE II ("Acute Physiology and Chronic Health Evaluation II") is a severity-of-disease classification system; an integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death
Original Secondary Outcome:
- Time to shock reversal [ Time Frame: 7 days ]
- Reduction of APACHE II Score [ Time Frame: 24 hours ]
Information By: Beth Israel Deaconess Medical Center
Dates:
Date Received: February 17, 2010
Date Started: February 2010
Date Completion:
Last Updated: April 29, 2017
Last Verified: April 2017