Thiamine Supplementation in Patients With Septic Shock

Sponsor

The Cleveland Clinic (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03122678

Collaborator

(none)

Enrollment

Location

Arms

28.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Septic Shock Shock, Septic Lactic Acidosis Thiamine Deficiency	Drug: Thiamine Drug: Placebos	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Thiamine Supplementation in Patients With Septic Shock: A Randomized, Double Blind, Placebo Controlled Trial

Actual Study Start Date :

Nov 5, 2016

Anticipated Primary Completion Date :

Mar 14, 2019

Anticipated Study Completion Date :

Mar 14, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Thiamine Other Names: Vitamin B1
Placebo Comparator: Placebo Group Patients will receive placebo (50mL 5% dextrose) once daily for 7 days or until discharge from the intensive care unit.	Drug: Placebos Other Names: 50mL 5% dextrose

Arm

Intervention/Treatment

Experimental: 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.

Drug: Thiamine

Other Names:

Vitamin B1

Placebo Comparator: Placebo Group

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

Drug: Placebos

Other Names:

50mL 5% dextrose

Outcome Measures

Primary Outcome Measures

Time to Reversal of Shock [7 days]
Number of hours that the patient required vasopressors
Time to Normalization of Lactic Acidosis [7 days]

Secondary Outcome Measures

ICU Mortality [From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months]
Death occurring during the ICU stay
ICU Length of Stay [From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months]
Number of days that the patient remains in the ICU after admission to the ICU

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)