Skip to content

Impact of Albumin on Renal function in critically ill patients with Septic Shock and a high risk of Acute Kidney Injury. A Randomized Controlled Trial.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518475-58-00
Acronym
ALBUMIR-AKI
Enrollment
100
Registered
2025-02-03
Start date
2025-05-15
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

acute kidney injury, Septic shock

Brief summary

The primary outcome will be the incidence of AKI, KDIGO stage 2-3 according to KDIGO guidelines during the first 7 days since septic shock onset

Detailed description

Incidence of 28-day mortality, Organ support status at day 28 measured as: length (hours) of vasopressors use; length (days) of invasive mechanical ventilation use; ventilation free days at 28 days; need of renal replacement therapy; and organ support free days at 28 days, Levels of: endothelial biomarkers Angiopoietin 1, Angiopoietin 2, MR-ProADM, Selectin, VCAM-1, ICAM-1, Endothelin-1, Thrombomodulin, Syndecan 1-4, Heparan sulfate, VEGF, S1P, and PAI-1, Proportion of participants with any AEs and SAEs related to albumin treatment, and also SUSARs

Interventions

Sponsors

Fundacio Parc Tauli
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary outcome will be the incidence of AKI, KDIGO stage 2-3 according to KDIGO guidelines during the first 7 days since septic shock onset

Secondary

MeasureTime frame
Incidence of 28-day mortality, Organ support status at day 28 measured as: length (hours) of vasopressors use; length (days) of invasive mechanical ventilation use; ventilation free days at 28 days; need of renal replacement therapy; and organ support free days at 28 days, Levels of: endothelial biomarkers Angiopoietin 1, Angiopoietin 2, MR-ProADM, Selectin, VCAM-1, ICAM-1, Endothelin-1, Thrombomodulin, Syndecan 1-4, Heparan sulfate, VEGF, S1P, and PAI-1, Proportion of participants with any AEs and SAEs related to albumin treatment, and also SUSARs

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026