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Thiamine as a Metabolic Resuscitator in Septic Shock

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Michael Donnino, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01070810
First received: February 17, 2010
Last updated: April 29, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Septic Shock Drug: D5W Drug: Thiamine Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Thiamine as a Metabolic Resuscitator in Septic Shock

Resource links provided by NLM:


Further study details as provided by Michael Donnino, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Lactate Level 24 Hours After the First Study Medication Dose [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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

  • 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


Enrollment: 88
Study Start Date: February 2010
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
50 ml D5W
Drug: D5W
Dextrose 5%
Experimental: 2
200mg Thiamine in 50ml D5W
Drug: Thiamine
Thiamine 200mg in 50ml D5W

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070810

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Michael W Donnino, MD Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Michael Donnino, Michael W. Donnino, MD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01070810     History of Changes
Other Study ID Numbers: 2008P000053
Study First Received: February 17, 2010
Results First Received: January 20, 2016
Last Updated: April 29, 2017

Keywords provided by Michael Donnino, Beth Israel Deaconess Medical Center:
Septic Shock
Sepsis

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Thiamine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 17, 2017