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.
Brief Title
Thiamine as a Renal Protective Agent 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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Sepsis
Kidney Injury
Thiamine Deficiency
Eligibility 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
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
Inclusion 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
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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03550794
Org Class
Other
Org Full Name
Beth Israel Deaconess Medical Center
Org Study Id
2018P-000204
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Thiamine as a Renal Protective Agent in Septic Shock: A Randomized, Controlled Study
Primary Outcomes
Outcome Description
Change in creatinine over time
Outcome Measure
Kidney Injury Biomarker
Outcome Time Frame
Enrollment to 72-hours
Secondary Outcomes
Outcome Description
Number of participants who received renal replacement therapy in thiamine and placebo groups.
Outcome 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
Outcome Measure
Number of Participants Receiving Renal Replacement Therapy
Outcome Description
Days alive and free of the ICU through day 28
Outcome Time Frame
From date of enrollment until 28 days after enrollment
Outcome Measure
ICU Free Days
Outcome Description
Length of hospital stay truncated at 60 days
Outcome Time Frame
From date of enrollment until discharge from the hospital or date of death, whichever comes first, up to 60 days after enrollment
Outcome Measure
In-hospital Mortality
Outcome Description
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).
Outcome 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
Outcome Measure
Number of Participants Experiences Acute Renal Failure
Outcome Description
Change in lactate level between enrollment and 72 hours after enrollment
Outcome Time Frame
From time of enrollment until 72 hours after enrollment
Outcome Measure
Change in Lactate Level
Outcome Description
Number of Participants with Delirium on Day 3 after enrollment
Outcome Time Frame
Day 3 after enrollment
Outcome Measure
Number of Participants With Delirium on Day 3
Outcome Description
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.
Outcome Time Frame
Time of enrollment until 72 hours after enrollment
Outcome Measure
Change in the Sequential Organ Failure Assessment Score
Outcome Description
KIM-1, NGAL, Cystatin-C at 24-hours after enrollment
Outcome Time Frame
24 hours after enrollment
Outcome Measure
Novel Biomarkers of Renal Injury
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ari Moskowitz
Investigator Email
amoskowitz@montefiore.org
Investigator Phone