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NCT Number: NCT03550794

Thiamine as a Renal Protective Agent in Septic Shock

This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous thiamine (vitamin B1) on renal function in septic shock.

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Key information

Conditions

Sepsis Avitaminosis Deficiency Diseases Infections Inflammation Kidney Injury Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome Thiamine Deficiency Vitamin B Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • Renal replacement therapy within the past 30 days
  • Comfort measures only or anticipated withdrawal of support within 24 hours
  • Protected populations (pregnant women, prisoners)
  • Known thiamine allergy

Treatment and study plan

Thiamine Hydrochloride

Drug

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

Drug

50ml of 0.9% NACL will serve as the placebo

Other names: Normal Saline, 0.9%NACL

Primary outcomes

  1. Kidney Injury Biomarker

    Time frame: Enrollment to 72-hours

    Change in creatinine over time

Secondary outcomes

  1. Number of Participants Receiving 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

    Number of participants who received renal replacement therapy in thiamine and placebo groups.

  2. ICU Free Days

    Time frame: From date of enrollment until 28 days after enrollment

    Days alive and free of the ICU through day 28

  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

  4. Number of Participants Experiences Acute Renal Failure

    Time frame: From date of enrollment until day of discharge from the index ICU admission or date of death, whichever comes first up until 60 days post-enrollment

    Acute renal failure as defined by the KDIGO (Kidney Disease Improving Global Outcomes) AKI (Acute Kidney Injury) criteria. In brief, a patient can meet these criteria if their serum creatinine increases (for example, serum creatinine increases to 1.5x or higher of baseline serum creatinine, or if it crosses 4mg/dL), or if renal replacement therapy is initiated, or if urine output decreases (for example, <0.5ml/kg/hour for 6-12 hours) or if patient becomes anuric (no urine production).

  5. Change in Lactate Level

    Time frame: From time of enrollment until 72 hours after enrollment

    Change in lactate level between enrollment and 72 hours after enrollment

  6. Number of Participants With Delirium on Day 3

    Time frame: Day 3 after enrollment

    Number of Participants with Delirium on Day 3 after enrollment

  7. Change in the Sequential Organ Failure Assessment Score

    Time frame: Time of enrollment until 72 hours after enrollment

    Change in Sequential Organ Failure Assessment Score (SOFA) score between enrollment and 72 hours after enrollment. SOFA scores are reported on a scale between 0-24, with 0 representing best outcome and 24 representing worst outcome.

  8. Novel Biomarkers of Renal Injury

    Time frame: 24 hours after enrollment

    KIM-1, NGAL, Cystatin-C at 24-hours after enrollment

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

Thiamine as a Renal Protective Agent in Septic Shock: A Randomized, Controlled Study

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jun 8, 2018
Registry last updated
Jun 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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