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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 below
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I am 18 years old or older.
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I am about to start or continue dialysis for acute kidney injury.
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I am on medication to control my blood pressure or using a machine to help me breathe.
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I have been in the ICU for more than a day.

ALTER-AKI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 365 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 365 days for reporting.

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 more

ALTER-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
561 Previous Clinical Trials
2,784,835 Total Patients Enrolled
3 Trials studying Acute Kidney Injury
120 Patients Enrolled for Acute Kidney Injury
The Physicians' Services Incorporated FoundationOTHER
162 Previous Clinical Trials
25,899 Total Patients Enrolled
The Kidney Foundation of CanadaOTHER
14 Previous Clinical Trials
2,109 Total Patients Enrolled
2 Trials studying Acute Kidney Injury
167 Patients Enrolled for Acute Kidney Injury

Media Library

20-25% Albumin fluid (Albumin) Clinical Trial Eligibility Overview. Trial Name: NCT04705896 — Phase 4
Acute Kidney Injury Research Study Groups: 20-25% Albumin fluid, Normal Saline
Acute Kidney Injury Clinical Trial 2023: 20-25% Albumin fluid Highlights & Side Effects. Trial Name: NCT04705896 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In which cases is 20-25% Albumin fluid prescribed as a form of treatment?

"Commonly used to treat peritonitis, 20-25% Albumin fluid has also been utilized for mitigating the effects of liver failure, acute hypovolemia and adult respiratory distress syndrome."

Answered by AI

Is enrollment open for this research endeavor?

"According to clinicaltrials.gov, the recruiting period for this medical experiment has been concluded as it was last updated on October 24th 2022. Despite that, there are 1,710 other trials actively looking for participants at present time."

Answered by AI

Have any other clinical experiments explored the efficacy of 20-25% Albumin fluid?

"Initially researched in 2007 at Herbert Irving Pavilion 11th Floor, 20-25% Albumin fluid has gone on to be studied extensively; with a total of 174 completed trials and 133 ongoing studies, many taking place in Montreal."

Answered by AI

Does this clinical trial represent a pioneering approach?

"Currently, 133 live clinical trials for 20-25% Albumin fluid are running in 918 cities and 32 different nations. The first such experiment was initiated by Celgene Corporation back in 2007 with 47 participants taking part - it ran through two phases of drug approval before ending successfully. Since this initial test, 174 more studies have been concluded on the matter."

Answered by AI

What results is the medical trial expected to yield?

"The primary objective of this 28-day trial is to assess hemodynamic stability. Secondary outcome measurements will involve ICU mortality, death or requirement for RRT within 90 days, and a major adverse kidney event which entails mortality, need for renal replacement therapy (RRT), or sustained reduction in glomerular filtration rate (GFR). GFR values are estimated using the CKD-EPI Creatinine equation with no race coefficient included; units are mL/min/1.73 m2."

Answered by AI

What possible risks are associated with the infusion of 20-25% Albumin fluid?

"Power has assigned a score of 3 to 20-25% Albumin fluid due to the high levels of safety associated with approved Phase 4 treatments."

Answered by AI

How widespread is the availability of this research trial?

"This clinical research is conducted at 5 major medical sites, including Centre hospitalier de l'Université de Montréal in Montreal, The Ottawa Hospital in Ottawa, and University of Ottawa Heart Institute in Toronto."

Answered by AI

How many people are actively participating in this trial?

"This investigation is not presently accepting applications. Initially posted on December 1st 2022 and last modified on October 24th 2022, this trial has since stopped recruitment of participants. However, there are still 1577 trials searching for critical illness patients and 133 clinical studies looking to recruit those with 20-25% Albumin fluid levels."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Albumin To Enhance Recovery After Acute Kidney Injury
Edward Clark 2023. "Albumin To Enhance Recovery After Acute Kidney Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04705896.
~571 spots leftby Aug 2025
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