The Effect of high-dose Thiamine supplementation in Cirrhosis with Sepsis patient; A randomized-controlled trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260520004

Enrollment

Registered

2026-05-20

Start date

2026-05-16

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with cirrhosis defined by any imaging modality including alcohol-related cirrhosis of any severity and cirrhosis of any etiology classified as Child-Pugh class B or C, who are hospitalized with sepsis or septic shock who meet the eligibility criteria(as defined by the inclusion and exclusion criteria) will be informed about the study and will be asked to provide written informed consent prior to participation. Thiamine Cirrhosis with Sepsis Randomized-controlled trial

Interventions

Intervention group (high-dose thiamine): Vitamin B1 500 mg IV q 8 hr * 3 days Standard sepsis treatment/care ,Control group: (Standard dose thiamine) Vitamin B1 100 mg IV q 12 hr * 3 days Standard

Active Comparator Drug,Placebo Comparator Drug

Intervention group(High dose thiamine),Control group(Standard dose thiamine)

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patient age must be 20 years or older. 2. Cirrhosis defined by any imaging modality, including 2.1 Alcohol-related cirrhosis of any severity. 2.2 Cirrhosis of any etiology classified as Child-Pugh class B or C. 3. Hospitalized with sepsis or septic shock according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). 4. Initial blood lactate level more than 2 mmol/L.

Exclusion criteria

Exclusion criteria: 1. Received more than 100 mg of vitamin B1 per day prior to enrollment in last 3 months 2. Known allergy or hypersensitivity to vitamin B1 3. Pregnant 4. Declined to participate in the study

Design outcomes

Primary

Measure	Time frame
Laboratory (Lactate decline) At 2,6,24 hr post-dose Laboratory (Lactate decline : mmol/L) Repeated Measure Analysis	—

Secondary

Measure	Time frame
Effect side At day 1 and 3 Laboratory (change of NTproBNP : pg/mL , IL-6: pg/ml , Cr : mg/dl),Effect side At day 7 Laborator (vasopressor free day),Effect side At day 28/discharge Mortality : percentage , LOS : day	—

Countries

Thailand

Contacts

Public ContactSuvijak Thinwong

Faculty of Medicine, Chiang Mai University

ari2nga2to@gmail.com053936120

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026