The Recovery After Dialysis-Requiring Acute Kidney Injury (RAD-AKI) Pilot Study is a 2-arm randomized clinical trial of hospitalized patients with dialysis-requiring acute kidney injury (RAD-AKI), comparing conventional thrice-weekly intermittent hemodialysis dialysis (control) to a "conservative dialysis strategy" in which hemodialysis is not continued unless specific metabolic or clinical indications for RRT are present. The overall hypothesis is that the current practice of thrice-weekly acute intermittent hemodialysis for AKI-D masks evidence of renal recovery and may actually delay or preclude recovery. The primary objective of this pilot study is to assess the safety and feasibility of the proposed intervention and study design.
The recent landmark Artificial Kidney Initiation in Kidney Injury (AKIKI) trial showed that a delayed strategy for RRT initiation among patients with incident stage 3 AKI - in which RRT was delayed unless specific metabolic or clinical indications for RRT were present - was safe and averted the need for RRT in nearly half of the critically ill participants, in comparison to an early RRT initiation strategy. The hypothesis for this study is: for prevalent patients with established AKI-D, a conservative dialysis strategy - in which hemodialysis is not continued unless specific metabolic or clinical indications for RRT are present - will shorten time to RRT-independence and improve the likelihood of renal recovery. The RAD-AKI Pilot Study is a 2-arm randomized clinical trial of hospitalized patients with dialysis-requiring acute kidney injury (RAD-AKI) that will compare conventional thrice-weekly intermittent hemodialysis dialysis (control) to a "conservative dialysis strategy." The primary objective of this pilot study is to assess the safety and feasibility of the proposed intervention and study design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Participants will receive RRT only when meeting 1 of the following indications (patterned after the AKIKI trial's delayed RRT initiation arm): * Blood urea nitrogen \>112 mg/dL (40 mmol/L) * Serum potassium concentration \>6 mmol/L * Serum potassium concentration \>5.5 mmol/L despite medical treatment (e.g., bicarbonate, glucose-insulin infusion, albuterol, diuretics, sodium polystyrene sulfonate) * Arterial blood gas pH \<7.15 in a context of pure metabolic acidosis (PaCO2 \<35 mmHg) or in a context of mixed acidosis with PaCO2 50 mmHg despite medical treatment to reverse respiratory acidosis (e.g., naloxone), or in the absence of an available arterial blood gas, serum bicarbonate \<12 mmol/L * Acute pulmonary edema due to fluid overload, responsible for hypoxemia requiring oxygen flow rate \>5 L/min to maintain SpO2 \>95% or requiring FiO2 \>50% in patients already on invasive or non-invasive mechanical ventilation and despite diuretic therapy
Thrice-weekly acute intermittent hemodialysis schedule.
UCSF Medical Center Moffitt-Long Hospital
San Francisco, California, United States
Protocol adherence [feasibility measure]
Number of times a participant in the "conservative dialysis" arm receives dialysis despite not meeting one of the pre-specified indications for dialysis, number of times a participant in the "TIW dialysis" arm is dialyzed off-schedule
Time frame: Through completion of active study participation (anticipated <2 weeks for each participant)
Number of participants with adverse events in each arm [safety measure]
Both serious and non-serious adverse events will be monitored, including arrhythmias due to metabolic disturbances, death, emergent dialysis needs, and transfer to ICU or intubation after enrollment
Time frame: Through completion of active study participation (anticipated <2 weeks for each participant)
Patient-reported symptoms
Survey will assess dyspnea, light-headedness, intradialytic cramping, pain and impaired mobility due to edema
Time frame: Through completion of active study participation (anticipated <2 weeks for each participant)
Hospital length of stay
Length of inpatient admission, starting after study enrollment
Time frame: Through completion of active study participation (anticipated <2 weeks for each participant)
Recovery status at 30, 60, and 90 days after dialysis initiation
Assessment of recovery status via phone call or e-mail contact
Time frame: From enrollment to 90 days after dialysis initiation for each patient
Screen-to-enroll ratio [feasibility measure]
Ratio of number of participants who meet eligibility criteria to number of participants who actually enroll into the study
Time frame: Through study completion (anticipated 2 years total)
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