This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous thiamine (vitamin B1) on renal function in septic shock.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
95
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.
50ml of 0.9% NACL will serve as the placebo
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Northshore University Hospital
Manhasset, New York, United States
Montefiore Medical Center
New York, New York, United States
Long Island Jewish Hospital
Queens, New York, United States
Kidney Injury Biomarker
Change in creatinine over time
Time frame: Enrollment to 72-hours
Number of Participants Receiving Renal Replacement Therapy
Number of participants who received renal replacement therapy in thiamine and placebo groups.
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
ICU Free Days
Days alive and free of the ICU through day 28
Time frame: From date of enrollment until 28 days after enrollment
In-hospital Mortality
Length of hospital stay truncated at 60 days
Time frame: From date of enrollment until discharge from the hospital or date of death, whichever comes first, up to 60 days after enrollment
Number of Participants Experiences Acute Renal Failure
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).
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
Change in Lactate Level
Change in lactate level between enrollment and 72 hours after enrollment
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Time frame: From time of enrollment until 72 hours after enrollment
Number of Participants With Delirium on Day 3
Number of Participants with Delirium on Day 3 after enrollment
Time frame: Day 3 after enrollment
Change in the Sequential Organ Failure Assessment Score
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.
Time frame: Time of enrollment until 72 hours after enrollment
Novel Biomarkers of Renal Injury
KIM-1, NGAL, Cystatin-C at 24-hours after enrollment
Time frame: 24 hours after enrollment