Recovery After Dialysis-Requiring Acute Kidney Injury

Acute Kidney Injury Clinical Trial

— RAD-AKI  

Official title:

Recovery After Dialysis-Requiring Acute Kidney Injury Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03305549
• Other study ID #: F32DK115030
• Status: Terminated
• Phase: N/A
• Start date: September 29, 2017
• Est. completion date: November 13, 2019

Study information

• Verified date: November 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: November 13, 2019
• Est. primary completion date: November 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Adult inpatients with AKI-D due to acute tubular necrosis who have already initiated renal replacement therapy

• If initiated on CRRT, patients will be eligible only if they have already tolerated 1 intermittent hemodialysis (IHD) session at the research site.

• If transferred from an outside hospital, eligible patients must have tolerated 1 IHD session at the research site prior to enrollment.

• Not requiring vasopressor support

• Not intubated and not having a supplemental oxygen requirement of >5 L/min via nasal cannula

• Treating MDs (nephrology and primary team attendings) and patient (or legally authorized representative) consent to enrollment

Exclusion Criteria:

• Diagnosis of end-stage renal disease (ESRD) or chronic dialysis prior to hospitalization

• Baseline estimated glomerular filtration rate (eGFR) <15 mL/min/1.73m2

• Liver transplant unit patients

• Patients who underwent kidney transplantation during index hospitalization

• Cause of AKI-D is complete nephrectomy

• Current pregnancy

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Other:
• Conservative dialysis strategy
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
• TIW dialysis strategy
Thrice-weekly acute intermittent hemodialysis schedule.

Locations

Country	Name	City	State
United States	UCSF Medical Center Moffitt-Long Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Through completion of active study participation (anticipated <2 weeks for each participant)
Primary	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	Through completion of active study participation (anticipated <2 weeks for each participant)
Secondary	Patient-reported symptoms	Survey will assess dyspnea, light-headedness, intradialytic cramping, pain and impaired mobility due to edema	Through completion of active study participation (anticipated <2 weeks for each participant)
Secondary	Hospital length of stay	Length of inpatient admission, starting after study enrollment	Through completion of active study participation (anticipated <2 weeks for each participant)
Secondary	Recovery status at 30, 60, and 90 days after dialysis initiation	Assessment of recovery status via phone call or e-mail contact	From enrollment to 90 days after dialysis initiation for each patient
Secondary	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	Through study completion (anticipated 2 years total)