Albumin Normalization to Prevent Hypotension and Recovery From Severe Acute Kidney Injury

• ClinicalTrials.gov Identifier: NCT04705896
• Recruitment Status: Not yet recruiting
• First Posted: January 12, 2021
• Last Update Posted: January 12, 2021
• Sponsor: Ottawa Hospital Research Institute
• Information provided by (Responsible Party): Edward Clark, Ottawa Hospital Research Institute

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:

1. Reduces hemodynamic instability and/or;
2. Improves achievement of fluid removal goals with RRT.

Condition or disease	Intervention/treatment	Phase
Acute Kidney Injury; Renal Replacement Therapy; Hypotension; Urologic Diseases; Vascular Diseases; Cardiovascular Diseases	Biological: Alburex 25% Albumin fluid (100 mL); Other: 0.9% Normal Saline (100 mL)	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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Albumin Normalization to Prevent Hypotension and Enhance Recovery From Severe Acute Kidney Injury Treated With Renal Replacement Therapy: A Proof-of-Concept Study
• Estimated Study Start Date: February 2021
• Estimated Primary Completion Date: March 2022
• Estimated Study Completion Date: April 2022

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 :

1. Hemodynamic instability [ Time Frame: 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 :

1. Fluid removal [ Time Frame: 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.
2. Patient mortality [ Time Frame: Through study completion, an average of 1 year. ]
   Mortality within 90 days of intervention.
3. Patient recovery [ Time Frame: Through study completion, an average of 1 year. ]
   Recovery in 90 days to dialysis-independence.
4. ICU and hospital length of stay [ Time Frame: Through study completion, an average of 1 year. ]
   Length of stay in ICU and total hospital length of stay.
5. Duration on ventilator [ Time Frame: Through study completion, an average of 1 year. ]
   Days on ventilator after start of RRT.
6. RRT duration in ICU and hospitalization [ Time Frame: Through study completion, an average of 1 year. ]
   Days on RRT in ICU and hospitalization.
7. One year mortality [ Time Frame: 24 months. ]
   Mortality within one year since intervention.
8. One year dialysis-independence [ Time Frame: 24 months. ]
   Dialysis-independence after one year.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Age ≥18 years old;
• Admitted under the care of the ICU;
• AKI treated with RRT (stage 3 AKI per Kidney Disease Improving Global Outcomes (KDIGO) AKI guidelines;
• Most recent serum albumin < 30 g/L.

Exclusion Criteria:

• RRT initiated for a non-AKI-related indication (such as concurrent intoxication; treatment of hypothermia);
• Any RRT within the previous 1 month;
• Kidney transplant within 1 year;
• History of allergic reaction to albumin;
• Pregnancy;
• Traumatic brain injury;
• Advanced cirrhosis and/or hepatorenal syndrome;
• Patients with contraindications or known objections to blood transfusions.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Edward Clark, Principal Investigator, Ottawa Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT04705896
• Other Study ID Numbers: CRF1819
• First Posted: January 12, 2021
• Last Update Posted: January 12, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Acute Kidney Injury; Urologic Diseases; Cardiovascular Diseases; Hypotension; Vascular Diseases; Wounds and Injuries; Renal Insufficiency; Kidney Diseases