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The effect of intravenous thiamine supplementation on AKI outcomes in sepsis patients: A randomized controlled trial

The effect of intravenous thiamine supplementation on AKI outcomes in sepsis patients: A randomized controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250526004
Enrollment
110
Registered
2025-05-26
Start date
2024-07-02
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

Acute kidney injury in Sepsis patient Acute Kidney Injury, Sepsis, Thiamine Supplementation, Renal Replacement Therapy, Critical Care, Major Adverse Kidney Events

Interventions

received thiamine 200 mg in 100 mL solution in 0.9% sodium chloride infused over 30 minutes intravenously every 12 hours for seven days, in addition to standard sepsis care,standard sepsis care
Active Comparator Drug,No Intervention No treatment
Thiamine supplementation group,Standard care group

Sponsors

Phramongkutklao hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adult patients (aged 20 years or more) 2. Sepsis defined according to Sepsis-3 criteria with Sequential Organ Failure Assessment (SOFA) score 2 points or more 3. Suspected or confirmed infection 4. presenting to the emergency department or admitted to inpatient units at Phramongkutklao Hospital

Exclusion criteria

Exclusion criteria: 1. pre-existing AKI as defined by KDIGO criteria at the time of initial assessment 2. chronic kidney disease (CKD) stage 4 or more (eGFR less than 30 mL/min/1.73) or history of renal replacement therapy 3. post-renal or pre-renal AKI 4. cirrhotic patients with Child-Turcotte-Pugh score B or C 5. medical conditions requiring thiamine supplementation as standard care 6. known allergy to thiamine 7. conditions requiring fluid restriction that would prevent standard volume resuscitation

Design outcomes

Primary

MeasureTime frame
Incidence of Acute kidney injury(AKI) within 7 days of enrollment AKI defined according to KDIGO criteria(Kidney Disease: Improving Global Outcomes)

Secondary

MeasureTime frame
In-hospital mortality in admission dead,In-hospital Major adverse kidney events (MAKE) within 7 days of enrollment dead, new renal replacement therapy, or persistent renal dysfunction,Renal replacement therapy requirement during hospital stays Renal replacement therapy requirement,Hospital length of stay during hospital stays number of Hospital length of stay,Lactate clearance within 7 days of enrollment calculated Lactate level as percent change in lactate levels from baseline to days 1, 2, 3, and 7.

Countries

Thailand

Contacts

Public Contactbordin tuntianunanon

Phramongkutklao hospital

bordin.tun@pmk.ac.th6627633278

Outcome results

None listed

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