Acute Kidney Injury, Hypotension, Renal Replacement Therapy
Conditions
Keywords
Albumin, Normal Saline, Dialysis, Intensive Care Unit
Brief summary
Objective: The primary aim of this 60 patient feasibility trial is to determine if, for critically ill patients treated with SLED for AKI, randomization to receive albumin (25%) boluses versus normal saline placebo boluses is feasible, with respect to the recruitment rate, blinding and adherence to the protocol.
Detailed description
Background: Intravenous albumin (25%) boluses are frequently given to critically ill patients during slow low-efficiency dialysis (SLED) treatments for acute kidney injury (AKI). The intention of giving albumin during SLED is to stabilize the blood pressure to permit more aggressive overall fluid removal with ultrafiltration; however, there is little evidence to support this expensive practice. Objective: The primary aim of this feasibility trial is to determine if, for critically ill patients treated with SLED for AKI, randomization to receive albumin (25%) boluses versus normal saline placebo boluses is feasible, with respect to the recruitment rate, blinding and adherence to the protocol. The results of this feasibility trial will help us to plan and carry out a multicentre pilot trial comparing the efficacy of the interventions in achieving fluid removal in critically ill patients with AKI on SLED. Design: A randomized controlled trial with two parallel arms. Setting: The mixed medical-surgical intensive care units of a Canadian tertiary care hospital. Study Population: 60 patients with AKI requiring treatment with SLED (by definition, Kidney Disease Improving Global Outcomes (KDIGO) stage 3 AKI). Intervention: Participants will be randomized to receive either albumin (25%) boluses or normal saline placebo boluses during their SLED treatments.
Interventions
BIOLOGICAL25% Albumin fluid
25% Albumin fluid (100 mL)
OTHERNormal Saline
0.9% Normal Saline (100 mL)
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The packaging for normal saline and 25% albumin will be identical (glass bottles) and be covered. The intravenous tubing will have an opaque sleeve to mask any colour discrepancy in the 2 products
Intervention model description
A randomized controlled trial with two parallel arms 1:1
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. age ≥ 18 yrs; 2. AKI treated with SLED (stage 3 AKI per Kidney Disease Improving Global Outcomes (KDIGO) AKI guidelines48).
Exclusion criteria
1. SLED initiated for non AKI-related indication (i.e. concurrent intoxication; treatment of hypothermia); 2. receiving chronic dialysis treatments; 3. history of allergic reaction to albumin; 4. pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 24 months | Percentage of eligible patients that are successfully recruited into the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completeness of follow-up | 24 months | Percentage of patients who have complete data available with respect to the primary and other secondary outcomes at the end of the study. |
| Volume removal achieved during SLED sessions | Through study completion, on average 1 year. | Overall fluid removal (i.e. percentage of target ultrafiltration achieved)calculated as the actual ultrafiltration volume divided by the target (ordered) ultrafiltration volume). |
| Adherence to intervention | Through study completion, on average 1 year. | Percentage of SLED sessions in which patients received their allocated intervention (or placebo). |
| Change in mean arterial blood pressure (MAP) < 55 mmHg during SLED sessions | Through study completion, on average 1 year. | Percentage of SLED sessions during which patients' MAP (defined as \[(2X diastolic blood pressure) + systolic blood pressure\]/3) falls to \<55 mmHg at any time during the SLED session. |
| Change in MAP of >=20 mmHg during the SLED sessions. | Through study completion, on average 1 year. | Percentage of SLED sessions during which patients' MAP falls by \>=20 mmHg relative to their MAP at the start of the SLED session. |
| New or increased vasopressor use during SLED sessions | Through study completion, on average 1 year. | Initiation or any increase in vasopressor dose(s) before the completion of a SLED session relative to the start. |
Countries
Canada
Outcome results
None listed