Thiamine Supplementation in Patients With Septic Shock

NCT ID: NCT03122678

Last Updated: 2019-03-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-05
• Study Completion Date: 2019-03-14

Brief Summary

To determine if intravenous thiamine would decrease the time to reversal of shock in patients with septic shock.

Detailed Description

Patients will be randomized to thiamine supplementation or placebo in a 1:1 ratio. Randomization will be done by the hospital pharmacy department whom will be the only unblinded participants. Patients will receive 200mg thiamine in 50mL of 5% dextrose or matching placebo (50mL 5% dextrose) once daily for 7 days or until discharge from the intensive care unit. The drug will be mixed by the pharmacy. Administration will be done in the patients room in the intensive care unit by the patient's assigned nurse. Blood will be collected on admission to the hospital in order to determine baseline lactate level and study eligibility. The measurement of lactate is standard of care in patients with sepsis. Thiamine level will be collected upon enrollment into the study. The ICU nurse or emergency room nurse taking care of the patient at the time of enrollment will draw the blood sample. Standard procedure for measuring thiamine levels will be maintained including protecting the blood sample from light and keeping it on ice while it is delivered to the lab. Serum lactate will be measured daily for 7 days or until discharge from the intensive care unit. The serial measurement of serum lactate is considered standard of care in patients with sepsis.

Conditions

Septic Shock; Shock, Septic; Lactic Acidosis; Thiamine Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Thiamine Supplementation Group

Patients will receive 200mg thiamine in 50mL of 5% dextrose once daily for 7 days or until discharge from the intensive care unit.

Group Type: EXPERIMENTAL

Thiamine

Intervention Type: DRUG

Placebo Group

Patients will receive placebo (50mL 5% dextrose) once daily for 7 days or until discharge from the intensive care unit.

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

Interventions

Thiamine

Intervention Type: DRUG

Placebos

Intervention Type: DRUG

Other Intervention Names

Vitamin B1; 50mL 5% dextrose

Eligibility Criteria

Inclusion Criteria

• Age>18
• Sepsis (defined as presence of two or more SIRS criteria with documented or suspected infection)
• SIRS: Systemic Inflammatory Response Syndrome (SIRS) is the occurrence of at least two of the following criteria: temperature >38.0ºC or <36.0ºC, heart rate >90 beats/minute, respiratory rate >20 breaths/minute, white blood cell count >12,000 or <4000.
• Lactate >3mmol/L at the time of consent and randomization
• Hypotension (systolic blood pressure <90mmHg) after a >2L fluid bolus
• Vasopressor dependence (defined as the continuous infusion of norepinephrine, dopamine, phenylephrine, vasopressin or epinephrine.)

Exclusion Criteria

• Known cirrhosis or chronic liver disease
• Current thiamine supplementation
• Clinical indication for thiamine (e.g. Alcohol abuse)
• Comfort measures only designation
• Inability to provide consent
• Other causes for lactate elevation (seizure, use of medications that can cause lactic acidosis such as metformin, linezolid and anti-retrovirals, carbon monoxide, known or suspected bowel or limb ischemia, cardiac arrest prior to enrollment)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Jinesh Mehta

Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jinesh Mehta, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Florida

Locations

Cleveland Clinic Florida

Weston, Florida, United States

Countries

United States

Other Identifiers

FLA 16-058

Identifier Type: -

Identifier Source: org_study_id