2025-01-28
minor
Study Identification, Study Status, Oversight, Contacts/Locations v4
Study titlerevised
Albumin toTo Enhance Recovery After Acute Kidney Injury
2024-10-17
minor
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Contacts/Locations v3
Start dateestimated 2023-11-01→confirmed 2023-11-02
Study sites5→7
Collaborators3 to 6 entries
Canadian Institutes of Health Research (CIHR)
Canadian Blood Services
Héma-Québec
Study titlerevised
Albumin Toto Enhance Recovery After Acute Kidney Injury
2023-10-30
notable
Not Yet Recruiting→Recruiting Study Status, Study Description, Study Design, Outcome Measures, Eligibility, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2022-12-01→2023-11-01
Enrollment target1046→856
Eligibility criteria+186 characters
Inclusion Criteria:
Age ≥18 years old;
Admission to a critical care unit/intensive care unit (ICU) for > 24 hours;
Receiving vasoactive therapy AND/OR undergoing mechanical ventilation (including non-invasive mechanical ventilation (NIMV));
Immediate initiation of RRT for management of AKI is planned OR additional RRT initiatedsessions are imminently planned for managementpatients ofwho AKIalready withinreceived theRRT precedingduring 24their hoursICU admission;
Exclusion Criteria:
PresenceInitiation of a non-AKI indication that triggers RRT initiationfor reasons other than AKI (e.g.
drug into [...] [...]
Secondary endpoints21 entries, revised
Number of participants with death in ICU, at 2128 days, and in-hospital
Occurrence of RRT-associated hypotension (for every RRT session in ICU after enrollmentrandomization)
Daily fluid balance after enrollmentrandomization up until ICU discharge or day 14, whichever comes first
Study description-2 characters
[...] entres across Canada and internationally.
Study Population: 1,096856 patients admitted to the Intensive Care Unit (ICU) with AKI [...]
Study sites5 entries, revised
CentreNiagara hospitalierHealth de l'Université de MontréalSystem
2022-10-24
minor
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v1
PhasePhase 2→Phase 4
Primary completion date2022-03→2025-08-28
Completion date2022-04→2025-10-23
Start date2021-02→2022-12-01
Enrollment target80→1046
Interventions0.9% Normal Saline (100 mL) (Other), Alburex 25% Albumin fluid (100 mL) (Biological)→0.9% Normal Saline (100 mL) (Other), 20-25% Albumin fluid (100 mL) (Biological)
Eligibility criteria+625 characters
Inclusion Criteria:
Age ≥18 years old;
AdmittedAdmission underto a critical care unit/intensive care unit (ICU);
Receiving vasoactive therapy AND/OR undergoing mechanical ventilation (including non-invasive mechanical ventilation);
Immediate initiation of RRT for management of AKI is planned OR RRT initiated for management of AKI within the carepreceding of24 the ICUhours;
AKI treated with RRT (stage 3 AKI per Kidney Disease Improving Global Outcomes (KDIGO) AKI guidelines;
Most recent serum albumin < 30 g/L.
Exclusion Criteria:
RRTPresence initiated forof a non-AKI-related indication that tri [...] [...]
Secondary endpoints8 to 21 entries
FluidRRT-free removaldays through day 28
PatientVasoactive mortalitytherapy free days
PatientMechanical recoveryventilation-free days
ICU andfree hospital lengthdays
Number of stayparticipants with death in ICU
DurationNumber onof ventilatorparticipants with all-cause mortality at 28 days
Number of participants with all-cause mortality at 90 days
Number of participants with death in ICU, at 21 days, and in-hospital
Number of participants with RRT durationdependence at 90 days among surviving patients
Number of participants with composite of death or RRT dependence at 90 days
eGFR will be evalu [...] [...]
Primary endpoints1 entry, revised
HemodynamicOrgan-support-free instabilitydays (OSFD)
Study description+841 characters
InBackground: OntarioSevere Acute Kidney Injury that necessitates renal replacement therapy (AKI-RRT) is a frequent complication of critical illness and portends severe outcomes: high morbidity, an approximately 1550% risk of in-hospital death, and increased healthcare resource utilization.
Although life-saving when needed, RRT itself may contribute to the poor outcomes associated with AKI-RRT.
Since RRT treatments frequently cause hypotension, repeated episodes of kidney and other organ ischemia may occur during RRT.
H [...] patients admitted to anthe Intensive Care Unit (ICU) developwith severeAKI [...]
Collaborators+162 characters
The Physicians' Services Incorporated Foundation
The Kidney Foundation of Canada
The Ottawa Hospital Academic Medical Organization (TOHAMO) Innovation Fund Grant.
Study title-36 characters
Albumin NormalizationTo to Prevent Hypotension andEnhance Recovery From SevereAfter Acute Kidney Injury