Albumin Normalization to Prevent Hypotension and Recovery From Severe Acute Kidney Injury
Study Details
Study Description
Brief Summary
Study objectives: To determine if, for critically ill patients on renal replacement therapy (RRT) for acute kidney injury (AKI), randomization to receive albumin fluid (25%) boluses versus normal saline placebo:
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Reduces hemodynamic instability and/or;
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Improves achievement of fluid removal goals with RRT.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
In Ontario, approximately 15% of patients admitted to an Intensive Care Unit (ICU) develop severe kidney failure that necessitates treatment with dialysis. Dialysis is a blood-cleaning treatment that replaces kidney function but does not actually help the kidneys to heal. While dialysis is life-saving, the treatments themselves may actually prevent the kidneys from recovering. This is because many patients experience low blood pressure (hypotension) during dialysis treatments. Hypotension can cause further damage to these patients' already-injured kidneys.
Some studies show that patients with higher blood levels of a protein called albumin may be protected from having hypotension during dialysis. Whether or not giving patients intravenous albumin can prevent hypotension during dialysis and lead to faster kidney recovery is unknown.
This study will determine if increasing ICU patients' blood albumin levels by giving them intravenous albumin fluid during dialysis treatments can prevent hypotension. The findings of this study could lead to faster kidney recovery and less need for ongoing dialysis treatments for patients who get severe kidney failure in ICU.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 25% Albumin fluid 100 mL 25% Albumin fluid at the initiation of slow low efficiency dialysis (SLED) or intermittent hemodialysis (IHD) and another 100 mL 25% Albumin fluid after 4 hours of treatment. |
Biological: Alburex 25% Albumin fluid (100 mL)
Participants will be randomized to receive albumin (25%) during their RRT sessions (either SLED or IHD) in ICU. Once randomized the same fluid will be given for all subsequent RRT sessions.
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).
|
| Placebo Comparator: Normal Saline 100 mL 0.9% Normal Saline at the initiation of SLED or IHD and another 100 mL 0.9% Normal Saline after 4 hours of treatment. |
Other: 0.9% Normal Saline (100 mL)
Participants will be randomized to receive normal saline 100 mL boluses during their RRT sessions (either SLED or IHD) in ICU. Once randomized the same fluid will be given for all subsequent RRT sessions.
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).
|
Outcome Measures
Primary Outcome Measures
- Hemodynamic instability [Through study completion, an average of 1 year.]
Change in mean arterial pressure (MAP) ≥ 20 mmHg from the start of renal replacement therapy (RRT) or initiation of/an increased dose of vasopressors required during RRT.
Secondary Outcome Measures
- Fluid removal [Through study completion, an average of 1 year.]
Net fluid removal rate relative to ordered fluid removal rate, lowest MAP during RRT; frequency of MAP ≥ 20 mmHg lower than at the start of RRT.
- Patient mortality [Through study completion, an average of 1 year.]
Mortality within 90 days of intervention.
- Patient recovery [Through study completion, an average of 1 year.]
Recovery in 90 days to dialysis-independence.
- ICU and hospital length of stay [Through study completion, an average of 1 year.]
Length of stay in ICU and total hospital length of stay.
- Duration on ventilator [Through study completion, an average of 1 year.]
Days on ventilator after start of RRT.
- RRT duration in ICU and hospitalization [Through study completion, an average of 1 year.]
Days on RRT in ICU and hospitalization.
- One year mortality [24 months.]
Mortality within one year since intervention.
- One year dialysis-independence [24 months.]
Dialysis-independence after one year.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18 years old;
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Admitted under the care of the ICU;
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AKI treated with RRT (stage 3 AKI per Kidney Disease Improving Global Outcomes (KDIGO) AKI guidelines;
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Most recent serum albumin < 30 g/L.
Exclusion Criteria:
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RRT initiated for a non-AKI-related indication (such as concurrent intoxication; treatment of hypothermia);
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Any RRT within the previous 1 month;
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Kidney transplant within 1 year;
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History of allergic reaction to albumin;
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Pregnancy;
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Traumatic brain injury;
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Advanced cirrhosis and/or hepatorenal syndrome;
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Patients with contraindications or known objections to blood transfusions.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Ottawa Hospital Research Institute
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRF1819