Trial record 12 of 78 for:    (NCCAM) [SPONSOR-COLLABORATORS] (recruiting) [OVERALL-STATUS] OR (NCCAM) [SPONSOR-COLLABORATORS] (not yet recruiting) [OVERALL-STATUS]

Thiamine as a Metabolic Resuscitator in Septic Shock

This study is currently recruiting participants.
Verified September 2013 by Beth Israel Deaconess Medical Center
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Michael Donnino, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01070810
First received: February 17, 2010
Last updated: September 26, 2013
Last verified: September 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Change in Lactate from time of study drug (or placebo) administration over 24 hours post delivery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to shock reversal [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Reduction of APACHE II Score [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 88
Study Start Date: February 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 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 Dextrose 5%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 20-30 cc/kg 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070810

Contacts
Contact: Michael W Donnino, MD 617-754-2295 mdonnino@bidmc.harvard.edu
Contact: Parth V Patel 617-754-2881 pvpatel@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Michael W Donnino, MD    617-754-2295    mdonnino@bidmc.harvard.edu   
Contact: Parth V Patel    617-754-2881    pvpatel@bidmc.harvard.edu   
Principal Investigator: Michael W Donnino, MD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Michael W Donnino, MD Beth Israel Deaconess Medical Center (BIDMC)
  More Information

No publications provided

Responsible Party: Michael Donnino, Michael W. Donnino, MD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01070810     History of Changes
Other Study ID Numbers: 2008P-000053
Study First Received: February 17, 2010
Last Updated: September 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by 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
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014