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Vitamin C & Thiamine in Sepsis

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ClinicalTrials.gov Identifier: NCT03592277
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : March 16, 2021
Sponsor:
Information provided by (Responsible Party):
Saint Francis Care

Brief Summary:
Investigators propose to investigate the use of IV vitamins B1 and C in a randomized, double-blinded, prospective trial to determine if these medications decrease mortality rates in patients with severe sepsis or septic shock.

Condition or disease Intervention/treatment Phase
Sepsis Septic Shock Drug: Vitamin C Drug: Vitamin B1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: All parties involved, except for pharmacy personnel will be blinded.
Primary Purpose: Treatment
Official Title: Vitamins B1 and C to Improve Outcomes in Patients With Severe Sepsis
Actual Study Start Date : September 14, 2018
Estimated Primary Completion Date : March 25, 2021
Estimated Study Completion Date : May 1, 2021


Arm Intervention/treatment
Experimental: Intervention Arm
Patients in this arm will receive 1.5g of vitamin C in 100mL of 0.9% sodium chloride (normal saline) every six hours for four days or until discharge from the ICU, whichever happens first (seventeen dose maximum). In addition, they will receive 200 mg IV vitamin B1 every 12 hours in 50 mL of normal saline for four days or until ICU discharge (whichever happens first, nine dose maximum).
Drug: Vitamin C
Patients will receive 1.5g of vitamin C in 100mL of 0.9% sodium chloride (normal saline) every six hours for four days or until discharge from the ICU, whichever happens first (seventeen dose maximum).
Other Name: Ascorbic Acid

Drug: Vitamin B1
Patients will also receive 200 mg of IV vitamin B1 every 12 hours in 50 mL of normal saline for four days or until ICU discharge (whichever happens first, nine dose maximum).
Other Name: Thiamine

No Intervention: Control Arm
Patients in the control arm will receive the 100 mL of 0.9% sodium chloride every six hours and 50 mL of 0.9% sodium chloride every 12 hours to act as placebos for the vitamins C and B1 respectively.



Primary Outcome Measures :
  1. Mortality Rates [ Time Frame: through study completion (average of 60 days) ]

Secondary Outcome Measures :
  1. hospital length of stay [ Time Frame: through study completion (average of 60 days) ]
  2. Intensive Care Unit length of stay [ Time Frame: through study completion (average of 60 days) ]
  3. readmission rate [ Time Frame: 30 day after hospital discharge ]
  4. ventilator days [ Time Frame: through study completion (average of 60 days) ]
    Number of days patient required ventilator

  5. hours on vasopressors [ Time Frame: through study completion (average of 60 days) ]
    Number of hours patient required vasopressors



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Patients must meet all inclusion criteria:

  1. Between the ages of 18 and 90 years old
  2. Have severe sepsis or septic shock. Severe sepsis and septic shock will be defined by the Surviving Sepsis 2012 guidelines.
  3. Weight more than 30 kg
  4. Full code

Exclusion Criteria:

  1. Not diagnosed with severe sepsis or septic shock
  2. Younger than 18 or older than 90 years old
  3. With a history of nephrolithiasis
  4. Who are pregnant
  5. Weigh less than 30 kg
  6. Not located in the ICU
  7. Do not resuscitate (DNR) or do not intubate (DNI), no escalation of care, or comfort measures only (CMO)
  8. Currently on dialysis

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): NCT03592277


Contacts
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Contact: David Shapiro, MD 860-714-5237 DShapiro@TrinityHealthOfNE.org

Locations
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United States, Connecticut
Saint Francis Hospital and Medical Center Recruiting
Hartford, Connecticut, United States, 06105
Contact: David S Shapiro, MD       DShapiro@TrinityHealthOfNE.org   
Sponsors and Collaborators
Saint Francis Care
Investigators
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Principal Investigator: David Shapiro, MD Saint Francis Hospital and Medical Center
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Responsible Party: Saint Francis Care
ClinicalTrials.gov Identifier: NCT03592277    
Other Study ID Numbers: SF-18-42
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Saint Francis Care:
Sepsis
Septic Shock
Vitamin C
Thiamine
Additional relevant MeSH terms:
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Sepsis
Toxemia
Shock, Septic
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Vitamins
Ascorbic Acid
Thiamine
Micronutrients
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamin B Complex