Acute Kidney Injury, Dialysis Hypotension
Conditions
Keywords
Dialysis-requiring Acute Kidney Injury, Renal Recovery
Brief summary
There are currently no therapies to improve the chances of recovering enough kidney function to come off of dialysis after severe acute kidney injury. It is not known if current routine outpatient dialysis treatments are optimized to maximize the chances of recovery. The purpose of this pilot study is to see if we can feasibly and safely provide several changes to the way that dialysis is provided in outpatient dialysis centers which may improve the chances of recovery.
Interventions
OTHERORKID Bundled Intervention
During the 90-day study period, participants will be prescribed outpatient hemodialysis with cooled dialysate (35-36°C), high sodium dialysate (145 mmol/L), a high ultrafiltration hold threshold (systolic blood pressure \> 110 mmHg; ultrafiltration hold threshold will not be applied in participants with baseline systolic blood pressure \< 120 mmHg), and high dose diuretics (160 mg oral furosemide twice daily) to be taken every day at home will also be prescribed. Dialysis will be weaned according to an active weaning protocol.
DRUGFurosemide
160 mg oral furosemide twice daily to be taken every day at home
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a single-center (multi-clinic), non-randomized pilot study to investigate the feasibility, tolerability, and safety of a bundled intervention (cooled dialysate, high sodium dialysate, high dose diuretics, high ultrafiltration hold threshold, active dialysis weaning) designed to foster recovery from acute kidney injury requiring dialysis.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* AKI-D (acute kidney injury requiring dialysis), attributed at least in part to acute tubular necrosis by clinical nephrology team * Age ≥ 18 years * Pre-hospitalization eGFR ≥ 15 mL/min/1.73m2 * Being discharged to a participating outpatient dialysis unit (within 30 miles of UCSF)
Exclusion criteria
* Known loop diuretic allergy/intolerance * Dialysis duration \> 3 months * Pregnant * Prisoner * Unable to consent * Clinical team declines to allow approach for study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Patients Who Received the Dialysate Temperature, Dialysate Sodium Concentration, Diuretic Dose, and Ultrafiltration Hold Threshold That Was Ordered at Least Once in the First Two Weeks of Treatment. | First two weeks of study intervention | Feasibility |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events; Both Serious and Non-serious Adverse Events Will be Monitored Including Electrolyte Abnormalities, Emergent Dialysis Treatments, and Hospitalizations. | Study day 90 | Safety |
| Time to Renal Recovery | Study day 90 | Days after study enrollment before renal recovery, defined as being alive and off dialysis for 14 consecutive days. |
| Proportion of Dialysis Sessions Complicated by Intradialytic Hypotension | Study day 90 | Defined as nadir systolic blood pressure \< 90 mmHg. |
| The Proportion of Enrolled Patients Completing the 90-day Study Still Continuing Each Intervention. | Study day 90 | Tolerability |
| Ratio of the Number of Participants Who Meet Inclusion Criteria to the Number of Participants Enrolled | Total study duration, anticipated 1 year | Screening-to-recruitment ratio |
| Modified Dialysis Symptom Index Score | Study day 0, 7, 14, 28, and 90 | — |
| Kidney Disease Quality of Life-36 Score | Study day 0, 7, 14, 28, and 90 | — |
| Number of Participants Enrolled Per Month | Total study duration, anticipated 1 year | Recruitment rate |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ORKID Bundled Intervention ORKID Bundled Intervention: During the 90-day study period, participants will be prescribed outpatient hemodialysis with cooled dialysate (35-36°C), high sodium dialysate (145 mmol/L), a high ultrafiltration hold threshold (systolic blood pressure \> 110 mmHg; ultrafiltration hold threshold will not be applied in participants with baseline systolic blood pressure \< 120 mmHg), and high dose diuretics (160 mg oral furosemide twice daily) to be taken every day at home will also be prescribed. Dialysis will be weaned according to an active weaning protocol.
Furosemide: 160 mg oral furosemide twice daily to be taken every day at home | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | ORKID Bundled Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity | NA participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
The Proportion of Patients Who Received the Dialysate Temperature, Dialysate Sodium Concentration, Diuretic Dose, and Ultrafiltration Hold Threshold That Was Ordered at Least Once in the First Two Weeks of Treatment.
Feasibility
Time frame: First two weeks of study intervention
Population: Only 1 participant was enrolled in this study, due to the possibility of identification, data will not be presented.
Secondary
Incidence of Adverse Events; Both Serious and Non-serious Adverse Events Will be Monitored Including Electrolyte Abnormalities, Emergent Dialysis Treatments, and Hospitalizations.
Safety
Time frame: Study day 90
Population: Only 1 participant was enrolled in this study, due to the possibility of identification, data will not be presented.
Secondary
Kidney Disease Quality of Life-36 Score
Time frame: Study day 0, 7, 14, 28, and 90
Population: Only 1 participant was enrolled in this study, due to the possibility of identification, data will not be presented.
Secondary
Modified Dialysis Symptom Index Score
Time frame: Study day 0, 7, 14, 28, and 90
Population: Only 1 participant was enrolled in this study, due to the possibility of identification, data will not be presented.
Secondary
Number of Participants Enrolled Per Month
Recruitment rate
Time frame: Total study duration, anticipated 1 year
Population: Only 1 participant was enrolled in this study, due to the possibility of identification, data will not be presented.
Secondary
Proportion of Dialysis Sessions Complicated by Intradialytic Hypotension
Defined as nadir systolic blood pressure \< 90 mmHg.
Time frame: Study day 90
Population: Only 1 participant was enrolled in this study, due to the possibility of identification, data will not be presented.
Secondary
Ratio of the Number of Participants Who Meet Inclusion Criteria to the Number of Participants Enrolled
Screening-to-recruitment ratio
Time frame: Total study duration, anticipated 1 year
Population: Only 1 participant was enrolled in this study, due to the possibility of identification, data will not be presented.
Secondary
The Proportion of Enrolled Patients Completing the 90-day Study Still Continuing Each Intervention.
Tolerability
Time frame: Study day 90
Population: Only 1 participant was enrolled in this study, due to the possibility of identification, data will not be presented.
Secondary
Time to Renal Recovery
Days after study enrollment before renal recovery, defined as being alive and off dialysis for 14 consecutive days.
Time frame: Study day 90
Population: Only 1 participant was enrolled in this study, due to the possibility of identification, data will not be presented.