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Albumin
Albumin for Acute Kidney Injury (ALTER-AKI Trial)
Phase 4
Recruiting
Led By Edward G Clark, MD MSc FRCPC
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years old
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 365 days
Awards & highlights
ALTER-AKI Trial Summary
This trialis testing if albumin boluses can help critically ill patients with AKI who need kidney dialysis to survive longer without organ support.
Who is the study for?
Adults over 18 in intensive care for more than a day, on life support or needing immediate kidney dialysis due to acute injury. Not for those with certain chronic kidney conditions, recent kidney transplants, severe liver issues, brain injuries, past severe reactions to albumin, or if they've had multiple dialysis sessions already.Check my eligibility
What is being tested?
The trial is testing if giving high-concentration albumin fluid during dialysis helps critically ill patients recover organ function faster compared to normal saline. Patients are randomly chosen to receive either the albumin or saline during their treatment.See study design
What are the potential side effects?
Potential side effects may include allergic reactions like anaphylaxis for those sensitive to albumin. Since it's being compared with normal saline which has minimal side effects, any additional risks primarily relate to the albumin infusion.
ALTER-AKI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am about to start or continue dialysis for acute kidney injury.
Select...
I am on medication to control my blood pressure or using a machine to help me breathe.
Select...
I have been in the ICU for more than a day.
ALTER-AKI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 365 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 365 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Organ-support-free days (OSFD)
Secondary outcome measures
Daily Sequential Organ Failure Assessment score (SOFA) score after enrollment up until ICU discharge or day 14, whichever comes first
Daily fluid balance after randomization up until ICU discharge or day 14, whichever comes first
Difference between ordered and achieved ultrafiltration for all intermittent HD / SLED treatments will be determined according to the medical record up until ICU discharge or day 14, whichever comes first
+18 moreALTER-AKI Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: 20-25% Albumin fluidActive Control1 Intervention
100 mL 20-25% Albumin fluid at the initiation of continuous renal replacement therapy (CRRT), prolonged intermittent renal replacement therapy (PIRRT), or intermittent hemodialysis (IHD) and another 100 mL 20-25% Albumin fluid and halfway through RRT sessions in ICU.
Group II: Normal SalinePlacebo Group1 Intervention
100 mL at the initiation of CRRT, SLED or IHD and another 100 mL 0.9% Normal Saline halfway through RRT sessions in ICU.
Find a Location
Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
564 Previous Clinical Trials
2,787,011 Total Patients Enrolled
3 Trials studying Acute Kidney Injury
120 Patients Enrolled for Acute Kidney Injury
The Physicians' Services Incorporated FoundationOTHER
163 Previous Clinical Trials
27,571 Total Patients Enrolled
The Kidney Foundation of CanadaOTHER
14 Previous Clinical Trials
2,089 Total Patients Enrolled
2 Trials studying Acute Kidney Injury
167 Patients Enrolled for Acute Kidney Injury
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with end-stage kidney disease before being hospitalized.My brain pressure is high, as shown by monitoring.I have had 2 or more kidney dialysis sessions in the ICU.I have severe liver damage with complications.I am 18 years old or older.I am about to start or continue dialysis for acute kidney injury.I have a traumatic brain injury.I had a kidney transplant within the last year.I am on medication to control my blood pressure or using a machine to help me breathe.I started renal replacement therapy for reasons not related to acute kidney injury.I started my kidney treatment with acute peritoneal dialysis.I cannot undergo certain intensive treatments or am planning to focus on comfort care.I have been in the ICU for more than a day.You have had a severe allergic reaction to intravenous albumin before.I may have a kidney blockage or severe kidney inflammation.
Research Study Groups:
This trial has the following groups:- Group 1: 20-25% Albumin fluid
- Group 2: Normal Saline
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
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