Testing 20-25% Albumin fluid (100 mL) against a placebo for acute kidney injury
Official title: Albumin To Enhance Recovery After Acute Kidney Injury
Albumin To Enhance Recovery After Acute Kidney Injury: A Multi-Centre, Randomized, Controlled Trial
- Phase 4
- 2 groups
- Sites in Calgary, Winnipeg and 11 more cities
- Recruiting
Interventions
- Biological therapy
20-25% Albumin fluid (100 mL)
Participants will be randomized to receive albumin (20-25%) during their RRT sessions (either CRRT, SLED or IHD) in ICU. Once randomized the same fluid will be given for all subsequent RRT sessions for up to 14 days in ICU. RRT sessions will be determined as per the treating physician. Boluses will be given at the start of, and halfway through, RRT sessions (i.e. for SLED sessions, at 0 and 4 hours; for IHD sessions, at 0 and 2 hours).
- Other intervention
0.9% Normal Saline (100 mL)
Participants will be randomized to receive normal saline 100 mL boluses during their RRT sessions (either CRRT, SLED or IHD) in ICU. Once randomized the same fluid will be given for all subsequent RRT sessions for up to 14 days in ICU. RRT sessions will be determined as per the treating physician. Boluses will be given at the start of, and halfway through, RRT sessions (e.g. for 8 hour SLED sessions, at 0 and 4 hours; for 4 hour IHD sessions, at 0 and 2 hours; for CRRT, after starting/randomization then every 12 hours while continuing on CRRT).
Canadian Sites (16)
9 of 16 recruiting
- Recruiting
Hamilton Health Sciences Corporation
Hamilton, Ontario
- Recruiting
Kingston General Hospital
Kingston, Ontario
- Recruiting
Sunnybrook Health Sciences Centre
North York, Ontario
- Recruiting
The Ottawa Hospital
Ottawa, Ontario
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario
- Recruiting
Niagara Health System
St. Catharines, Ontario
- Recruiting
Sinai Health System
Toronto, Ontario
- Recruiting
Centre Integre de Sante et de Services Sociaux de Laval
Laval, Quebec
- Recruiting
Centre Integre Universitaire de Sante et de Services Sociaux de L'Estrie - Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec
- Not yet recruiting
The Governors of the University of Calgary
Calgary, Alberta
- Not yet recruiting
University of Manitoba - Health Sciences Centre
Winnipeg, Manitoba
- Not yet recruiting
Nova Scotia Health Authority
Halifax, Nova Scotia
- Not yet recruiting
Scarborough Health Network
Scarborough Village, Ontario
- Not yet recruiting
St. Michael's Hospital
Toronto, Ontario
- Not yet recruiting
Lakeridge Health
Whitby, Ontario
- Not yet recruiting
University of Saskatchewan
Saskatoon, Saskatchewan
Eligibility Criteria
See who this study is looking for17 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 sessions are imminently planned for patients who already received RRT during their ICU admission;
Exclusion
- −Advanced cirrhosis (Child Pugh class C \[score 10-15\]), spontaneous bacterial peritonitis or hepatorenal syndrome;
- −Prior history of anaphylaxis to intravenous albumin
- −Initiation of RRT for reasons other than AKI (e.g. drug intoxication, hypothermia) ;
- −Known pre-hospitalization end-stage kidney disease;
- −Kidney transplant within the past 365 days;
- −Presence or clinical suspicion of renal obstruction, rapidly progressive glomerulonephritis, vasculitis, thrombotic microangiopathy or acute interstitial nephritis;
- −Acute peritoneal dialysis used as the initial RRT modality;
- −Contraindications to albumin:
- −Admitted with traumatic brain injury
- −Increased intra-cranial pressure in those with intra-cranial pressure monitoring
- −Contraindication or known objection to albumin/blood product transfusions
- −Already received 2 or more RRT sessions during ICU admission.
- −Limitations of medical therapy precluding RRT/mechanical ventilation/vasoactive medications or plan to transition to palliation
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 4Phase 4A study of a treatment that is already approved and in use.Read more → — a study of a treatment already approved for use, following it in everyday practice.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives 20-25% Albumin fluid (100 mL).
Registry label: A: 20-25% Albumin fluid
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives 0.9% Normal Saline (100 mL).
Registry label: B: Normal Saline
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 856 people.
The study is currently expected to finish around October 2025.
The main measurement is taken over: 28 days following randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Organ-support-free days (OSFD) — measured over 28 days following randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04705896 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 20-25% Albumin fluid (100 mL)Biological
Participants will be randomized to receive albumin (20-25%) during their RRT sessions (either CRRT, SLED or IHD) in ICU. Once randomized the same fluid will be given for all subsequent RRT sessions for up to 14 days in ICU. RRT sessions will be determined as per the treating physician. Boluses will be given at the start of, and halfway through, RRT sessions (i.e. for SLED sessions, at 0 and 4 hours; for IHD sessions, at 0 and 2 hours).
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About 0.9% Normal Saline (100 mL)Other
Participants will be randomized to receive normal saline 100 mL boluses during their RRT sessions (either CRRT, SLED or IHD) in ICU. Once randomized the same fluid will be given for all subsequent RRT sessions for up to 14 days in ICU. RRT sessions will be determined as per the treating physician. Boluses will be given at the start of, and halfway through, RRT sessions (e.g. for 8 hour SLED sessions, at 0 and 4 hours; for 4 hour IHD sessions, at 0 and 2 hours; for CRRT, after starting/randomization then every 12 hours while continuing on CRRT).
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 28 days following randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
The study as a whole is currently expected to finish around 2025-10-23.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 856 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 14 locations, including: Calgary, Alberta, Canada; Winnipeg, Manitoba, Canada; Halifax, Nova Scotia, Canada; Hamilton, Ontario, Canada; Kingston, Ontario, Canada; North York, Ontario, Canada, and 8 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Study objectives: To determine whether, in critically ill patients with Acute Kidney Injury requiring renal replacement therapy (AKI-RRT), randomization to receive intravenous hyperoncotic albumin 20-25% (100 mL X two doses) compared to control/placebo normal saline boluses (100 mL X two doses) given during RRT sessions, leads to: 1. An increase in organ support-free days (primary outcome) at 28 days following randomization; and 2. An increase in RRT-free days (principal secondary outcome) at 28 days following randomization.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.