Thiamine as a Metabolic Resuscitator in Septic Shock

Phase 1

Completed

• Conditions: Septic Shock
• Interventions: Drug: Thiamine; Drug: D5W

• Registration Number: NCT01070810
• Lead Sponsor: Beth Israel Deaconess Medical Center

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 Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-17
• Study First Submitted QC: 2010-02-17
• Study First Posted: 2010-02-18
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Results First Submitted: 2016-01-20
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-29
• Last Update Submitted: 2017-04-29
• Results First Posted: 2017-05-15
• Last Update Posted: 2017-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• 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

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Thiamine	200mg Thiamine in 50ml D5W
1	D5W	50 ml D5W

Primary Outcome Measures

Name	Time	Method
Lactate Level 24 Hours After the First Study Medication Dose	24 hours

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Shock Reversal	Hospital stay, average 2 weeks	Shock reversal was defined as \> 24 hours off all vasopressors
APACHE II Score at 24 Hours	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

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States