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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 : June 23, 2021
Sponsor:
Information provided by (Responsible Party):
Michael Donnino, Beth Israel Deaconess Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sepsis Kidney Injury Thiamine Deficiency Drug: Thiamine Hydrochloride Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
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
Official Title: Thiamine as a Renal Protective Agent in Septic Shock: A Randomized, Controlled Study
Actual Study Start Date : September 4, 2018
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arms and Interventions
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Arm Intervention/treatment
Experimental: Thiamine
200mg parenterally administered thiamine hydrochloride given twice daily for a 3 days (6 doses)
 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
Placebo Comparator: Placebo
Matching placebo (50ml 0.9%NACL) given twice daily for 3 days (6 administrations)
 Drug: Placebo
50ml of 0.9% NACL will serve as the placebo
Other Names:
  • Normal Saline
  • 0.9%NACL


Outcome Measures
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Primary Outcome Measures :
  1. Kidney injury biomarker [ Time Frame: Enrollment to 72-hours ]
    Change in creatinine over time


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03550794


Contacts
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Contact: Ari Moskowitz, MD 6177543464 amoskowi@bidmc.harvard.edu
Contact: Michael Donnino, MD 6177543463 mdonnino@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Ari Moskowitz, MD    617-754-5864    amoskowi@bidmc.harvard.edu   
United States, New York
Northshore University Hospital Active, not recruiting
Manhasset, New York, United States, 11030
Montefiore Medical Center Recruiting
New York, New York, United States, 10467
Contact: Ari Moskowitz, MD       amoskowitz@montefiore.org   
Long Island Jewish Hospital Active, not recruiting
Queens, New York, United States, 11040
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Ari Moskowitz, MD Beth Israel Deaconess Medical Center
More Information
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Publications:

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Responsible Party: Michael Donnino, Associate Professor of Emergency Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03550794    
Other Study ID Numbers: 2018P-000204
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 23, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thiamine Deficiency
Beriberi
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
 Nutrition Disorders
Thiamine
Vitamins
Micronutrients
Physiological Effects of Drugs
Vitamin B Complex