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Effects of add-on intravenous iron therapy versus standard care in sepsis patients with iron deficiency anemia: A randomized controlled trial

Effects of add-on intravenous iron therapy versus standard care in sepsis patients with iron deficiency anemia: A randomizedcontrolled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250407003
Enrollment
60
Registered
2025-04-07
Start date
2025-05-01
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

The participants in this study met the following inclusion criteria: Patients with suspected or confirmed bloodstream infection, as defined by the Sepsis-3 criteria, including those with septic shock. The infection must be adequately controlled, and the patient&#039

Interventions

Intravenous iron sucrose at a dose of 200 milligrams, with a maximum cumulative dose not exceeding 1,000 milligrams within 14 days, administered in conjunction with standard care during hospitalizatio
Experimental Drug,No Intervention No treatment
Intravenous iron ,Standard care

Sponsors

Thammasat University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Patients with suspected or confirmed bloodstream infection, as defined by the Sepsis-3 criteria, including those with septic shock. 2) The infection must be adequately controlled, and the patient's clinical condition must have remained stable for at least 48 hours, based on clinical evaluation. 3) Hemoglobin level less than 10 grams per deciliter. 4) Reticulocyte hemoglobin equivalent (Ret-He) less than 29 picograms, as measured and reported by the Sysmex analyzer. 5) Age equal to or greater than 18 years.

Exclusion criteria

Exclusion criteria: 1) Serum ferritin level equal to or greater than 1,200 nanograms per milliliter or transferrin saturation (TSAT) equal to or greater than 50%, based on the study by Litton E et al. (Reference No. 14). The assessment of ferritin and TSAT levels follows standard diagnostic criteria for anemia in patients with inflammation or critical illness. 2) History of haemochromatosis or aceruloplasminaemia. 3) Prior administration of intravenous iron within 3 months before hospital admission. 4) History of receiving erythropoiesis-stimulating agents (ESAs), such as erythropoietin or darbepoetin, within 3 months prior to hospital admission. 5) Known history of hypersensitivity to intravenous iron therapy. 6) Pregnant individuals. 7) Patients under a palliative care plan. 8) Body weight of less than 40 kilograms. Uncontrolled asthma.

Design outcomes

Primary

MeasureTime frame
Hemoglobin At time of discharge and 30 days after discharge gram per deciliter

Secondary

MeasureTime frame
Volume of blood transfusion At discharge number ,Length of hospital stay. At discharge number ,Mortality rate. At discharge number ,Rate of recurrent infection At discharge number,Incidence of adverse reactions At discharge number,Patient quality of life At 30 days after discharge number

Countries

Thailand

Contacts

Public ContactChirayu savedkairop

Thammasat university

c.savetkairop@gmail.com0635164893

Outcome results

None listed

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