Clinical trial NCT03550794: Thiamine as a Renal Protective Agent in Septic Shock
Official title: Thiamine as a Renal Protective Agent in Septic Shock: A Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sepsis
Kidney Injury
Thiamine Deficiency
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Kidney Injury Biomarker
timeFrame: Enrollment to 72-hours
Secondary outcomes:
measure: Number of Participants Receiving Renal Replacement Therapy
timeFrame: 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
measure: ICU Free Days
timeFrame: From date of enrollment until 28 days after enrollment
measure: In-hospital Mortality
timeFrame: From date of enrollment until discharge from the hospital or date of death, whichever comes first, up to 60 days after enrollment
measure: Number of Participants Experiences Acute Renal Failure
timeFrame: 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
measure: Change in Lactate Level
timeFrame: From time of enrollment until 72 hours after enrollment
measure: Number of Participants With Delirium on Day 3
timeFrame: Day 3 after enrollment
measure: Change in the Sequential Organ Failure Assessment Score
timeFrame: Time of enrollment until 72 hours after enrollment
measure: Novel Biomarkers of Renal Injury
timeFrame: 24 hours after enrollment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Manhasset
country: United States
facility: Northshore University Hospital
state: New York
city: New York
country: United States
facility: Montefiore Medical Center
state: New York
city: Queens
country: United States
facility: Long Island Jewish Hospital
state: New York
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Ari Moskowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moskowitz A, Andersen LW, Cocchi MN, Karlsson M, Patel PV, Donnino MW. Thiamine as a Renal Protective Agent in Septic Shock. A Secondary Analysis of a Randomized, Double-Blind, Placebo-controlled Trial. Ann Am Thorac Soc. 2017 May;14(5):737-741. doi: 10.1513/AnnalsATS.201608-656BC.
citation: Donnino MW, Andersen LW, Chase M, Berg KM, Tidswell M, Giberson T, Wolfe R, Moskowitz A, Smithline H, Ngo L, Cocchi MN; Center for Resuscitation Science Research Group. Randomized, Double-Blind, Placebo-Controlled Trial of Thiamine as a Metabolic Resuscitator in Septic Shock: A Pilot Study. Crit Care Med. 2016 Feb;44(2):360-7. doi: 10.1097/CCM.0000000000001572.