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Thiamine as a Metabolic Resuscitator in Septic Shock

Primary Purpose

Septic Shock

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
D5W
Thiamine
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring Septic Shock, Sepsis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

1

2

Arm Description

50 ml D5W

200mg Thiamine in 50ml D5W

Outcomes

Primary Outcome Measures

Lactate Level 24 Hours After the First Study Medication Dose

Secondary Outcome Measures

Number of Participants With Shock Reversal
Shock reversal was defined as > 24 hours off all vasopressors
APACHE II Score at 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

Full Information

First Posted
February 17, 2010
Last Updated
April 29, 2017
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01070810
Brief Title
Thiamine as a Metabolic Resuscitator in Septic Shock
Official Title
Thiamine as a Metabolic Resuscitator in Septic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
Septic Shock, Sepsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
50 ml D5W
Arm Title
2
Arm Type
Experimental
Arm Description
200mg Thiamine in 50ml D5W
Intervention Type
Drug
Intervention Name(s)
D5W
Intervention Description
Dextrose 5%
Intervention Type
Drug
Intervention Name(s)
Thiamine
Intervention Description
Thiamine 200mg in 50ml D5W
Primary Outcome Measure Information:
Title
Lactate Level 24 Hours After the First Study Medication Dose
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Number of Participants With Shock Reversal
Description
Shock reversal was defined as > 24 hours off all vasopressors
Time Frame
Hospital stay, average 2 weeks
Title
APACHE II Score at 24 Hours
Description
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
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
Lactate Level at 24 Hours in Patients With Baseline Thiamine Deficiency
Description
Baseline thiamine deficiency was defined as a baseline thiamine level of ≤ 7 nmol/L
Time Frame
24 hours
Title
Number of Participants Dying Before Hospital Discharge in Patients With Baseline Thiamine Deficiency
Description
Baseline thiamine deficiency was defined as a baseline thiamine level of ≤ 7 nmol/L
Time Frame
Hospital stay, average 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael W Donnino, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

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Thiamine as a Metabolic Resuscitator in Septic Shock

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