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Trial record 5 of 63 for:    thiamine | Recruiting, Not yet recruiting Studies

Thiamine as a Renal Protective Agent in Septic Shock

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ClinicalTrials.gov Identifier: NCT03550794
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Ari Moskowitz, Beth Israel Deaconess Medical Center

Tracking Information
First Submitted Date  ICMJE May 25, 2018
First Posted Date  ICMJE June 8, 2018
Last Update Posted Date October 23, 2019
Actual Study Start Date  ICMJE September 4, 2018
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2018)
Kidney injury biomarker [ Time Frame: Enrollment to 72-hours ]
Change in creatinine over time
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03550794 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2018)
  • Renal replacement therapy [ Time Frame: From date of enrollment until discharge from the intensive care unit (ICU) or date of death, whichever comes first, up to 60 days after enrollment ]
    Need for renal replacement therapy
  • Length of ICU stay [ Time Frame: From date of enrollment until discharge from the intensive care unit (ICU) or date of death, whichever comes first, up to 60 days after enrollment ]
    Length of ICU stay truncated at 60 days
  • In-hospital mortality [ Time Frame: From date of enrollment until discharge from the hospital or date of death, whichever comes first, up to 60 days after enrollment ]
    Length of hospital stay truncated at 60 days
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Thiamine as a Renal Protective Agent in Septic Shock
Official Title  ICMJE Thiamine as a Renal Protective Agent in Septic Shock: A Randomized, Controlled Study
Brief Summary This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous thiamine (vitamin B1) on renal function in septic shock.
Detailed Description This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous thiamine (vitamin B1) on renal injury in septic shock. Patients admitted with septic shock who have a lactate of at least 2.0mmol/L and do not have pre-existing renal failure requiring dialysis will be eligible for the study. Enrolled patients will be randomized to intravenous thiamine 200mg twice daily for 6 doses or matching placebo. Blood will be drawn at several time points to assess biomarkers of renal injury. Secondary endpoints include need for renal replacement therapy, length of ICU stay, and hospital mortality.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
A randomization list will be prepared by an independent statistician using 1:1 randomization in blocks of two and four. This list will be provided to the research pharmacy, and the research pharmacy will be the only unblinded people involved with the study, and will have no patient contact or role in the analysis or other aspects of the study. Thiamine is colorless and odorless, and the 200mg dose is mixed in 5mL of normal saline. Placebo will be 50mL of normal saline and is indistinguishable in appearance from thiamine. Study team, clinical team and patient and family will all be blind to the allocation.
Primary Purpose: Treatment
Condition  ICMJE
  • Sepsis
  • Kidney Injury
  • Thiamine Deficiency
Intervention  ICMJE
  • Drug: Thiamine Hydrochloride
    Thiamine hydrochloride is a water soluble vitamin (vitamin B1). 200mg of thiamine hydrochloride in 50ml 0.9%NACL will be administered twice daily for 3 days.
    Other Names:
    • Thiamine
    • Vitamin B1
  • Drug: Placebo
    50ml of 0.9% NACL will serve as the placebo
    Other Names:
    • Normal Saline
    • 0.9%NACL
Study Arms  ICMJE
  • Experimental: Thiamine
    200mg parenterally administered thiamine hydrochloride given twice daily for a 3 days (6 doses)
    Intervention: Drug: Thiamine Hydrochloride
  • Placebo Comparator: Placebo
    Matching placebo (50ml 0.9%NACL) given twice daily for 3 days (6 administrations)
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 7, 2018)
88
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adult ≥18 years of age
  2. Suspected or Confirmed Infection (defined as collection of a blood/fluid culture and provision of an antimicrobial)
  3. Receipt of a vasopressor agent (e.g. norepinephrine, phenylephrine, vasopressin)
  4. Serum lactate ≥2mmol/L
  5. Creatinine >1.0mg/dL

Exclusion Criteria:

  1. Clinical indication for thiamine administration (alcoholism, known or highly suspected deficiency) or treatment with thiamine beyond the amount found in a standard multivitamin within the last 10 days
  2. Renal replacement therapy within the past 30 days
  3. Comfort measures only or anticipated withdrawal of support within 24 hours
  4. Protected populations (pregnant women, prisoners)
  5. Known thiamine allergy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ari Moskowitz, MD 6177543464 amoskowi@bidmc.harvard.edu
Contact: Michael Donnino, MD 6177543463 mdonnino@bidmc.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03550794
Other Study ID Numbers  ICMJE 2018P-000204
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ari Moskowitz, Beth Israel Deaconess Medical Center
Study Sponsor  ICMJE Beth Israel Deaconess Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ari Moskowitz, MD Beth Israel Deaconess Medical Center
PRS Account Beth Israel Deaconess Medical Center
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP