Thiamine as a Renal Protective Agent in Septic Shock

Beth Israel Lahey Health

Status and phase: Completed; Phase 2

Conditions: Thiamine Deficiency; Kidney Injury; Sepsis

Treatments: Drug: Thiamine Hydrochloride; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03550794

2018P-000204

Details and patient eligibility

About

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

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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95 participants in 2 patient groups, including a placebo group

Thiamine

Experimental group

Description:

200mg parenterally administered thiamine hydrochloride given twice daily for a 3 days (6 doses)

Treatment:

Drug: Thiamine Hydrochloride

Placebo

Placebo Comparator group

Description:

Matching placebo (50ml 0.9%NACL) given twice daily for 3 days (6 administrations)

Treatment:

Drug: Placebo