Thiamine Supplementation in Patients With Septic Shock

NCT03122678 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: FLA 16-058
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Time to Reversal of Shock

  Number of hours that the patient required vasopressors

  7 days

• Time to Normalization of Lactic Acidosis

  7 days

Secondary Outcomes (2)

• 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

• 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

Study Arms (2)

Thiamine Supplementation Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Drug: Placebos

Interventions

Thiamine DRUG

Also known as: Vitamin B1

Thiamine Supplementation Group

Placebos DRUG

Also known as: 50mL 5% dextrose

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

MeSH Terms

Conditions

Shock, Septic; Acidosis, Lactic; Thiamine Deficiency

Interventions

Thiamine; Glucose

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Jinesh Mehta, MD

  Cleveland Clinic Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: April 21, 2017
• Study Start: November 5, 2016
• Primary Completion: March 14, 2019
• Study Completion: March 14, 2019
• Last Updated: March 15, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)