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Thiamine Supplementation in Patients With Septic Shock

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ClinicalTrials.gov Identifier: NCT03122678
Recruitment Status : Withdrawn (No participant enrolled)
First Posted : April 21, 2017
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Jinesh Mehta, The Cleveland Clinic

Brief Summary:
To determine if intravenous thiamine would decrease the time to reversal of shock in patients with septic shock.

Condition or disease Intervention/treatment Phase
Septic Shock Shock, Septic Lactic Acidosis Thiamine Deficiency Drug: Thiamine Drug: Placebos Phase 1

Detailed Description:
Patients will be randomized to thiamine supplementation or placebo in a 1:1 ratio. Randomization will be done by the hospital pharmacy department whom will be the only unblinded participants. Patients will receive 200mg thiamine in 50mL of 5% dextrose or matching placebo (50mL 5% dextrose) once daily for 7 days or until discharge from the intensive care unit. The drug will be mixed by the pharmacy. Administration will be done in the patients room in the intensive care unit by the patient's assigned nurse. Blood will be collected on admission to the hospital in order to determine baseline lactate level and study eligibility. The measurement of lactate is standard of care in patients with sepsis. Thiamine level will be collected upon enrollment into the study. The ICU nurse or emergency room nurse taking care of the patient at the time of enrollment will draw the blood sample. Standard procedure for measuring thiamine levels will be maintained including protecting the blood sample from light and keeping it on ice while it is delivered to the lab. Serum lactate will be measured daily for 7 days or until discharge from the intensive care unit. The serial measurement of serum lactate is considered standard of care in patients with sepsis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Thiamine Supplementation in Patients With Septic Shock: A Randomized, Double Blind, Placebo Controlled Trial
Actual Study Start Date : November 5, 2016
Estimated Primary Completion Date : March 14, 2019
Estimated Study Completion Date : March 14, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: Thiamine Supplementation Group
Patients will receive 200mg thiamine in 50mL of 5% dextrose once daily for 7 days or until discharge from the intensive care unit.
Drug: Thiamine
Other Name: Vitamin B1

Placebo Comparator: Placebo Group
Patients will receive placebo (50mL 5% dextrose) once daily for 7 days or until discharge from the intensive care unit.
Drug: Placebos
Other Name: 50mL 5% dextrose




Primary Outcome Measures :
  1. Time to Reversal of Shock [ Time Frame: 7 days ]
    Number of hours that the patient required vasopressors

  2. Time to Normalization of Lactic Acidosis [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. ICU Mortality [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]
    Death occurring during the ICU stay

  2. ICU Length of Stay [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]
    Number of days that the patient remains in the ICU after admission to the ICU



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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:

  • Age>18
  • Sepsis (defined as presence of two or more SIRS criteria with documented or suspected infection)
  • SIRS: Systemic Inflammatory Response Syndrome (SIRS) is the occurrence of at least two of the following criteria: temperature >38.0ºC or <36.0ºC, heart rate >90 beats/minute, respiratory rate >20 breaths/minute, white blood cell count >12,000 or <4000.
  • Lactate >3mmol/L at the time of consent and randomization
  • Hypotension (systolic blood pressure <90mmHg) after a >2L fluid bolus
  • Vasopressor dependence (defined as the continuous infusion of norepinephrine, dopamine, phenylephrine, vasopressin or epinephrine.)

Exclusion Criteria:

  • Known cirrhosis or chronic liver disease
  • Current thiamine supplementation
  • Clinical indication for thiamine (e.g. Alcohol abuse)
  • Comfort measures only designation
  • Inability to provide consent
  • Other causes for lactate elevation (seizure, use of medications that can cause lactic acidosis such as metformin, linezolid and anti-retrovirals, carbon monoxide, known or suspected bowel or limb ischemia, cardiac arrest prior to enrollment)

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): NCT03122678


Locations
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United States, Florida
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Jinesh Mehta, MD Cleveland Clinic Florida

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Responsible Party: Jinesh Mehta, Staff Physician, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03122678     History of Changes
Other Study ID Numbers: FLA 16-058
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
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
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Shock, Septic
Acidosis
Acidosis, Lactic
Thiamine Deficiency
Beriberi
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Acid-Base Imbalance
Metabolic Diseases
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Thiamine
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs