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OpenTrials
Completed

NCT Number: NCT01070810

Thiamine as a Metabolic Resuscitator in Septic Shock

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.

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

D5W

Drug

Dextrose 5%

Thiamine

Drug

Thiamine 200mg in 50ml D5W

Primary outcomes

  1. Lactate Level 24 Hours After the First Study Medication Dose

    Time frame: 24 hours

Secondary outcomes

  1. Number of Participants With Shock Reversal

    Time frame: Hospital stay, average 2 weeks

    Shock reversal was defined as > 24 hours off all vasopressors

  2. 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

Other outcomes

  1. Lactate Level at 24 Hours in Patients With Baseline Thiamine Deficiency

    Time frame: 24 hours

    Baseline thiamine deficiency was defined as a baseline thiamine level of ≤ 7 nmol/L

  2. Number of Participants Dying Before Hospital Discharge in Patients With Baseline Thiamine Deficiency

    Time frame: Hospital stay, average 2 weeks

    Baseline thiamine deficiency was defined as a baseline thiamine level of ≤ 7 nmol/L

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Feb 18, 2010
Registry last updated
May 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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