Effect of Early Vitamin B1 Treatment of blood lactate levels in ICU patients with septic shock

A Prospective randomised study to correlate the effectiveness of early thiamine administration based on lactate clearance in patients with septic shock admitted in ICU - nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/108835

Enrollment

105

Registered

2026-04-20

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: R652- Severe sepsis

Interventions

Intervention1: Thiamine: 100 mg OD, IV for every 12 hours Intervention2: Placebo: septic shock therapy without thiamine Control Intervention1: Placebo: septic shock management without thiamine

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients with septic shock older than 18 years Peak lactate greater than 2 mmol/L MAP less than 65 mmHg Patients who receive thiamine within 24 hours of the onset of septic shock

Exclusion criteria

Exclusion criteria: Patients who did not meet the sepsis 3 criteria of septic shock Chronic alcohol disease, liver disease

Design outcomes

Primary

Measure	Time frame
To determine the association between early thiamine administration and time to lactate clearance in patients with septic shock. Timepoint: Baseline lactate greater than 2 value on Day 1, and when will it decrease to lactate lower than 2 on Days 2, 3, 4, 5? By comparing the placebo and Thiamine patients with septic shock	—

Secondary

Measure	Time frame
To investigate the role of thiamine in reducing the incidence of acute kidney injury (AKI), minimizing the need for renal replacement therapy (RRT), and improving outcomes such as ICU stay duration, vasopressor-free days, and ventilator-free daysTimepoint: 6 Month	—

Countries

India

Contacts

Public ContactMagesh R

SRM medical college hospital and research center

balavivek04@gmail.com8220330594

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026