Acute Kidney InjuryPhase 4ALTER-AKINCT04705896
Albumin To Enhance Recovery After Acute Kidney Injury
A Phase 4 study testing 20-25% Albumin fluid (100 mL) and 0.9% Normal Saline (100 mL) in people with Acute Kidney Injury and Renal Replacement Therapy, run by Ottawa Hospital Research Institute at 16 sites in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Renal Replacement Therapy, Hypotension
- What is being tested?
- 20-25% Albumin fluid (100 mL) and 0.9% Normal Saline (100 mL)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 856 participants
- Where
- 16 sitesCanada
- Study dates
- 2 Nov 2023to 23 Oct 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
- Advanced cirrhosis (Child Pugh class C [score 10-15]), spontaneous bacterial peritonitis or hepatorenal syndrome;
- Acute peritoneal dialysis used as the initial RRT modality;
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- Contraindications to albumin:
- Admitted with traumatic brain injury
- Increased intra-cranial pressure in those with intra-cranial pressure monitoring
- Prior history of anaphylaxis to intravenous albumin
- 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
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
Canada16 sites, 16 recruiting
- Not yet recruiting
The Governors of the University of Calgary
Calgary, Alberta
Daniel Niven, MD
- Not yet recruiting
Nova Scotia Health Authority
Halifax, Nova Scotia
Volker Eichhorn, MD
- Recruiting
Hamilton Health Sciences Corporation
Hamilton, Ontario
Emilie Belley-Côté, MD
- Recruiting
Kingston General Hospital
Kingston, Ontario, K7L 2V7
Samuel A Silver, MD MSc FRCPC
Samuel A Silver, MD MSc FRCPC
- Recruiting
Centre Integre de Sante et de Services Sociaux de Laval
Laval, Quebec, H7M3L9
Marios Roussos, MD
- Recruiting
Sunnybrook Health Sciences Centre
North York, Ontario, M4N 3M5
Neill Adhikari, MD
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Irene Watpool, RN BScN, 613-737-8724, iwatpool@ohri.ca
Heather Langlois, BSc, 613-737-8899 ext. 72998, hlanglois@ohri.ca
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Rebecca Mathew, MD FRCPC
Rebecca Mathew, MD FRCPC
- Not yet recruiting
University of Saskatchewan
Saskatoon, Saskatchewan
Sabira Valiani, MD
- Not yet recruiting
Scarborough Health Network
Scarborough Village, Ontario
Chris Yarnell, MD
- Recruiting
Centre Integre Universitaire de Sante et de Services Sociaux de L'Estrie - Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec
François Lamontagne, MD
- Recruiting
Niagara Health System
St. Catharines, Ontario, L2S0A9
Jennifer Tsang, MD, PhD
Jennifer Tsang, MD, PhD
- Not yet recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Ron Wald, MDCM MPH
Ron Wald, MDCM MPH
- Recruiting
Sinai Health System
Toronto, Ontario, M5G1X5
Sangeeta Mehta, MD
- Not yet recruiting
Lakeridge Health
Whitby, Ontario, L1N 6K9
Shannon Fernando, MD
Shannon Fernando, MD
- Not yet recruiting
University of Manitoba - Health Sciences Centre
Winnipeg, Manitoba
Ryan Zarychanski, MD
About this study
Official title: Albumin To Enhance Recovery After Acute Kidney Injury: A Multi-Centre, Randomized, Controlled 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:
- An increase in organ support-free days (primary outcome) at 28 days following randomization; and
- An increase in RRT-free days (principal secondary outcome) at 28 days following randomization.
Read the detailed description
Background: Severe 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 50% 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. Hypotension during RRT is often triggered by fluid removal. At the same time, there is some evidence that more aggressive ultrafiltration could be beneficial in AKI-RRT.
Albumin is a protein that is the primary contributor to the colloid oncotic pressure maintaining the effective circulating volume (ECV) during RRT. Critically ill patients with AKI-RRT are nearly always hypoalbuminemic. Despite its high cost and limited evidence to support the practice, intravenous hyperoncotic albumin is commonly administered to patients with AKI-RRT in an effort to boost the colloid oncotic pressure and maintain the blood pressure while simultaneously facilitating fluid removal
Objective:
This proposed trial is intended to provide definitive evidence as to the efficacy of a frequently used and expensive intervention to promote hemodynamic stability and augment ultrafiltration during RRT in critically ill patients
Design: A randomized controlled trial with two parallel arms. Setting: The mixed medical-surgical intensive care units of five Canadian tertiary care hospitals with plans to expand to include other centres across Canada and internationally.
Study Population: 856 patients admitted to the Intensive Care Unit (ICU) with AKI requiring treatment with RRT .
Intervention: Participants will be randomized 1:1 to receive either albumin (20-25%) boluses or normal saline placebo boluses at the start and halfway through RRT sessions in ICU, during their RRT treatments to a maximum of 14 days.
- Being tested
- 20-25% Albumin fluid (100 mL), 0.9% Normal Saline (100 mL)
- Keywords
- Albumin, Normal Saline, Dialysis, Intensive Care Unit
- Medical subject headings
- Acute Kidney Injury, Hypotension, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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).
| Study group | Role | What they receive |
|---|---|---|
| 20-25% Albumin fluid | Active comparator | 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. Receives: Biological: 20-25% Albumin fluid (100 mL) |
| Normal Saline | Placebo comparator | 100 mL at the initiation of CRRT, SLED or IHD and another 100 mL 0.9% Normal Saline halfway through RRT sessions in ICU. Receives: Other: 0.9% Normal Saline (100 mL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Organ-support-free days (OSFD)
Organ support-free days are defined as days that are both: 1) vasoactive therapy-free; AND 2) mechanical ventilation-free (including NIMV). For patients who die within 28 days following randomization, organ support-free days are counted as -1. An OSFD will be defined as the receipt of < 2 hours of any vasoactive therapy provided by continuous infusion AND the receipt of < 2 hours of either invasive or non-invasive mechanical ventilation, within a 24-hour period.
Measured: 28 days following randomization
Secondary outcomes (21)
RRT-free days through day 28
For each patient, one point will be given for each calendar day that a patient was free of RRT. For patients who die within 28 days following randomization, RRT-free days are counted as -1.
An RRT-free day will be defined as a 24-period in which < 2hours of CRRT was received within a 24-hour period and no intermittent RRT sessions were started during the 24-hour period.
Measured: Through day 28
Vasoactive therapy free days
For patients who die within 28 days following initiation of randomization, vasoactive therapy-free days are counted as -1.
Vasoactive therapy-free days will be defined as receipt of < 2 hours of any vasoactive therapy provided by continuous infusion within a 24-hour period
Measured: Through day 28
Mechanical ventilation-free days
For patients who die within 28 days following initiation of randomization, mechanical ventilation-free days are counted as -1.
Mechanical ventilation-free days will be defined as receipt of < 2 hours of either invasive or non-invasive ventilation during a 24-hour period. Invasive mechanical ventilation is that provided via endotracheal tube (including tracheostomy). Noninvasive ventilation will be counted when more than 5 cm H2O of continuous positive airway pressure and more than 5 cm H2O of pressure support when deployed to avoid intubation. Other uses of noninvasive ventilation (eg, chronic nighttime use for chronic obstructive pulmonary disease) will not be counted.
Measured: Though day 28.
ICU free days
For patients who die within 28 days following initiation of randomization, ICU-free days are counted as being -1.
ICU-free days will be defined as admission to an ICU for < 2 hours within a 24-hour period
Measured: Through 28 days
Number of participants with death in ICU
Mortality within 28 days since randomization
Measured: Through 28 days
Number of participants with all-cause mortality at 28 days
Mortality within 28 days since randomization
Measured: Through 28 days
Number of participants with all-cause mortality at 90 days
Mortality within 90 days since randomization.
Measured: Through 90 days.
Number of participants with death in ICU, at 28 days, and in-hospital
Days from randomization to death in ICU, at 28 days or in-hospital
Measured: Through 90 days
Number of participants with RRT dependence at 90 days among surviving patients
Defined by the receipt of any form of RRT within +/- 14 days of the 90-day time point following randomization for those alive at 90-days following randomization
Measured: Through 90 days.
Number of participants with composite of death or RRT dependence at 90 days
Defined as death within 90-days following randomization or the receipt of any form of RRT within +/- 14 days of the 90-day time point following randomization
Measured: Through 90 days.
eGFR will be evaluated in all patients alive at Day 90
Serum creatinine will be drawn at day 90 (or as close as possible to day 90) and not beyond 132 days after randomization (i.e. we will accept a serum creatinine from Day 90 minus 14 days to Day 90 plus 42 days). eGFR will be derived from the CKD-EPI Creatinine (2021) equation that excludes the race-based coefficient and expressed in mL/min/1.73 m2
Measured: At 90 days
Major adverse kidney outcomes, defined as death, RRT dependence, or sustained reduction in kidney function (defined as eGFR < 75% baseline eGFR) at 90 days.
eGFR will be derived from the CKD-EPI Creatinine (2021) equation that excludes the race-based coefficient69 and expressed in mL/min/1.73 m2
Measured: Through 90 days
Hospitalization-free days
Defined as a 24-hour period completely free of an inpatient hospitalization.
Measured: Through 90 days.
EuroQoL EQ-5D-5L which includes a descriptive system (scored from 5 (worst) to 25 (best)) and a visual analogue scale (scored from 0 (worst) to 100 (best)) at day 90.
Survivors at 90 days will be contacted and evaluated using the EQ-5D-5L which is a measure of health-related quality of life and patient utility
Measured: At 90 days
Occurrence of RRT-associated hypotension (for every RRT session in ICU after randomization)
Defined as: a drop in blood pressure during RRT requiring initiation or increase in dose of a vasopressor during RRT session or premature discontinuation of RRT session due to hypotension
Measured: Through 14 days
Daily fluid balance after randomization up until ICU discharge or day 14, whichever comes first
Daily net fluid will be calculated based on the medical chart
Measured: Day 14 or ICU discharge
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
volume will be determined according to the medical record
Measured: Day 14 or ICU discharge
Daily Sequential Organ Failure Assessment score (SOFA) score after enrollment up until ICU discharge or day 14, whichever comes first
The renal component of the SOFA score will be calculated on the basis of urine output only (as all participants will receive RRT and this impacts the creatinine value).
The GCS score will not be used for the total score (GCS score is difficult is accurately determine in an intubated and sedated participant)
Measured: Day 14 or ICU discharge
Health Care Costs
An economic evaluation will include the cost of the intervention and control will be assessed using a micro-costing approach,1plus any implications on length of stay, safety events associated with the intervention and/or control, and the costs associated with RRT-dependence up to 365 days following randomizationTo measure these impacts, we will assess hospital and ICU use, physician claims, and subsequent outpatient claims for RRT for all patients within the trial. Consistent with usual practice within a multi-centre clinical trial, valuation of costs will be done for the subset of all patients enrolled within the province of Ontario, Canada (extrapolated based on all patients in the trial) using administrative costing data available from the Institute for Clinical Evaluative Sciences (IC/ES).
Measured: Through 365 days.
Number of alive participants with RRT-dependence at 365 days
defined by the patient having a kidney transplant or receipt of any form of RRT within 14 days before or after the 365-days post-randomization time-point
Measured: Through 365 days
Number of participants with all-cause mortality at 365 days
Mortality within 365 days since randomization.
Measured: Through 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start2 Nov 2023
- Primary completion28 Aug 2025 (estimated)
- Study completion23 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial with two parallel arms 1:1
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 856 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation, The Kidney Foundation of Canada, The Ottawa Hospital Academic Medical Organization (TOHAMO) Innovation Fund Grant., Canadian Institutes of Health Research (CIHR), Canadian Blood Services, Héma-Québec
- Responsible party
- Principal investigator, Edward Clark, Ottawa Hospital Research Institute
- Investigators
- Edward G Clark, MD MSc FRCPC, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705896
- Sponsor's protocol ID
- CRF1819
- Acronym
- ALTER-AKI
- Status last verified
- Apr 2025
- First submitted
- 7 Jan 2021
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data collected during the ALTER-AKI trial will be shared with researchers who provide a detailed and methodologically sound proposal, with specific aims. Data sharing will be for the purposes of medical research, with specific data elements provided to answer the research questions in the proposal, and under the auspices of the consent under which the data were originally gathered
Publications
Ullrich EK, Callum J, Clark EG. Use of Intravenous Albumin in Nephrology Practice Should Be Guideline-Based. J Am Soc Nephrol. 2025 Apr 30;36(7):1446-1449. doi: 10.1681/ASN.0000000750. No abstract available.
PubMed 40305120
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Albumin To Enhance Recovery After Acute Kidney Injury: A Multi-Centre, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04705896
- Acronym / sponsor ID
- ALTER-AKI / CRF1819
- Keywords
- Albumin, Normal Saline, Dialysis, Intensive Care Unit
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 856 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation, The Kidney Foundation of Canada, The Ottawa Hospital Academic Medical Organization (TOHAMO) Innovation Fund Grant., Canadian Institutes of Health Research (CIHR), Canadian Blood Services, Héma-Québec
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 28 Aug 2025 (estimated)
- Study completion
- 23 Oct 2025 (estimated)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- An increase in organ support-free days (primary outcome) at 28 days following randomization; and
- An increase in RRT-free days (principal secondary outcome) at 28 days following randomization.
Detailed description
Background: Severe 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 50% 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. Hypotension during RRT is often triggered by fluid removal. At the same time, there is some evidence that more aggressive ultrafiltration could be beneficial in AKI-RRT.
Albumin is a protein that is the primary contributor to the colloid oncotic pressure maintaining the effective circulating volume (ECV) during RRT. Critically ill patients with AKI-RRT are nearly always hypoalbuminemic. Despite its high cost and limited evidence to support the practice, intravenous hyperoncotic albumin is commonly administered to patients with AKI-RRT in an effort to boost the colloid oncotic pressure and maintain the blood pressure while simultaneously facilitating fluid removal
Objective:
This proposed trial is intended to provide definitive evidence as to the efficacy of a frequently used and expensive intervention to promote hemodynamic stability and augment ultrafiltration during RRT in critically ill patients
Design: A randomized controlled trial with two parallel arms. Setting: The mixed medical-surgical intensive care units of five Canadian tertiary care hospitals with plans to expand to include other centres across Canada and internationally.
Study Population: 856 patients admitted to the Intensive Care Unit (ICU) with AKI requiring treatment with RRT .
Intervention: Participants will be randomized 1:1 to receive either albumin (20-25%) boluses or normal saline placebo boluses at the start and halfway through RRT sessions in ICU, during their RRT treatments to a maximum of 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled trial with two parallel arms 1:1
| Arm | Type | Receives |
|---|---|---|
| 20-25% Albumin fluid | Active comparator | Biological: 20-25% Albumin fluid (100 mL)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. |
| Normal Saline | Placebo comparator | Other: 0.9% Normal Saline (100 mL)100 mL at the initiation of CRRT, SLED or IHD and another 100 mL 0.9% Normal Saline halfway through RRT sessions in ICU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
- Advanced cirrhosis (Child Pugh class C [score 10-15]), spontaneous bacterial peritonitis or hepatorenal syndrome;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Biological | 20-25% Albumin fluid |
| 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). | Other | Normal Saline |
Primary outcome
Organ-support-free days (OSFD)
Time frame: 28 days following randomization
Organ support-free days are defined as days that are both: 1) vasoactive therapy-free; AND 2) mechanical ventilation-free (including NIMV). For patients who die within 28 days following randomization, organ support-free days are counted as -1. An OSFD will be defined as the receipt of < 2 hours of any vasoactive therapy provided by continuous infusion AND the receipt of < 2 hours of either invasive or non-invasive mechanical ventilation, within a 24-hour period.
21 secondary outcomes
RRT-free days through day 28
Time frame: Through day 28
Vasoactive therapy free days
Time frame: Through day 28
Mechanical ventilation-free days
Time frame: Though day 28.
ICU free days
Time frame: Through 28 days
Number of participants with death in ICU
Time frame: Through 28 days
Number of participants with all-cause mortality at 28 days
Time frame: Through 28 days
Number of participants with all-cause mortality at 90 days
Time frame: Through 90 days.
Number of participants with death in ICU, at 28 days, and in-hospital
Time frame: Through 90 days
Number of participants with RRT dependence at 90 days among surviving patients
Time frame: Through 90 days.
Number of participants with composite of death or RRT dependence at 90 days
Time frame: Through 90 days.
eGFR will be evaluated in all patients alive at Day 90
Time frame: At 90 days
Major adverse kidney outcomes, defined as death, RRT dependence, or sustained reduction in kidney function (defined as eGFR < 75% baseline eGFR) at 90 days.
Time frame: Through 90 days
Hospitalization-free days
Time frame: Through 90 days.
EuroQoL EQ-5D-5L which includes a descriptive system (scored from 5 (worst) to 25 (best)) and a visual analogue scale (scored from 0 (worst) to 100 (best)) at day 90.
Time frame: At 90 days
Occurrence of RRT-associated hypotension (for every RRT session in ICU after randomization)
Time frame: Through 14 days
Daily fluid balance after randomization up until ICU discharge or day 14, whichever comes first
Time frame: Day 14 or ICU discharge
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
Time frame: Day 14 or ICU discharge
Daily Sequential Organ Failure Assessment score (SOFA) score after enrollment up until ICU discharge or day 14, whichever comes first
Time frame: Day 14 or ICU discharge
Health Care Costs
Time frame: Through 365 days.
Number of alive participants with RRT-dependence at 365 days
Time frame: Through 365 days
Number of participants with all-cause mortality at 365 days
Time frame: Through 365 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Derived from this study: PubMed 40305120Ullrich EK, Callum J, Clark EG. Use of Intravenous Albumin in Nephrology Practice Should Be Guideline-Based. J Am Soc Nephrol. 2025 Apr 30;36(7):1446-1449. doi: 10.1681/ASN.0000000750. No abstract available.
- Individual participant dataSharing planned: Yes. De-identified individual participant data collected during the ALTER-AKI trial will be shared with researchers who provide a detailed and methodologically sound proposal, with specific aims. Data sharing will be for the purposes of medical research, with specific data elements provided to answer the research questions in the proposal, and under the auspices of the consent under which the data were originally gathered
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edward G Clark, MD MSc FRCPC principal investigator
Ottawa Hospital Research Institute
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 20-25% Albumin fluid (100 mL) and 0.9% Normal Saline (100 mL) in people with Acute Kidney Injury and Renal Replacement Therapy, run by Ottawa Hospital Research Institute at 16 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edward G Clark, MD MSc FRCPC (613-737-8899 ext. 82569, edclark@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Organ-support-free days (OSFD) (time frame: 28 days following randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04705896, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.