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Inadequate recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ORKID Bundled Intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORKID Bundled Intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | First two weeks of study intervention |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Enrolled Patients Completing the 90-day Study Still Continuing Each Intervention. | Tolerability | Study day 90 |
| Incidence of Adverse Events; Both Serious and Non-serious Adverse Events Will be Monitored Including Electrolyte Abnormalities, Emergent Dialysis Treatments, and Hospitalizations. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian McCoy, MD, MS | University of California, San Franisco | Principal Investigator |
| Chi-yuan Hsu, MD, MSc | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Only 1 participant was enrolled in this study, due to the possibility of identification, data will not be presented. | Posted | First two weeks of study intervention |
|
1 month
Only 1 participant was enrolled in this study, due to the possibility of identification, data will not be presented.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ian McCoy | University of California, San Francisco | 415-476-2172 | ian.mccoy@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 17, 2023 | Apr 18, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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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.
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|
| Furosemide | Drug | 160 mg oral furosemide twice daily to be taken every day at home |
|
Safety |
| Study day 90 |
| Time to Renal Recovery | Days after study enrollment before renal recovery, defined as being alive and off dialysis for 14 consecutive days. | Study day 90 |
| Proportion of Dialysis Sessions Complicated by Intradialytic Hypotension | Defined as nadir systolic blood pressure < 90 mmHg. | Study day 90 |
| Number of Participants Enrolled Per Month | Recruitment rate | Total study duration, anticipated 1 year |
| Ratio of the Number of Participants Who Meet Inclusion Criteria to the Number of Participants Enrolled | Screening-to-recruitment ratio | Total study duration, anticipated 1 year |
| 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 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
|
| Secondary | The Proportion of Enrolled Patients Completing the 90-day Study Still Continuing Each Intervention. | Tolerability | Only 1 participant was enrolled in this study, due to the possibility of identification, data will not be presented. | Posted | Study day 90 |
|
|
| Secondary | Incidence of Adverse Events; Both Serious and Non-serious Adverse Events Will be Monitored Including Electrolyte Abnormalities, Emergent Dialysis Treatments, and Hospitalizations. | Safety | Only 1 participant was enrolled in this study, due to the possibility of identification, data will not be presented. | Posted | Study day 90 |
|
|
| Secondary | Time to Renal Recovery | Days after study enrollment before renal recovery, defined as being alive and off dialysis for 14 consecutive days. | Only 1 participant was enrolled in this study, due to the possibility of identification, data will not be presented. | Posted | Study day 90 |
|
|
| Secondary | Proportion of Dialysis Sessions Complicated by Intradialytic Hypotension | Defined as nadir systolic blood pressure < 90 mmHg. | Only 1 participant was enrolled in this study, due to the possibility of identification, data will not be presented. | Posted | Study day 90 |
|
|
| Secondary | Number of Participants Enrolled Per Month | Recruitment rate | Only 1 participant was enrolled in this study, due to the possibility of identification, data will not be presented. | Posted | Total study duration, anticipated 1 year |
|
|
| Secondary | Ratio of the Number of Participants Who Meet Inclusion Criteria to the Number of Participants Enrolled | Screening-to-recruitment ratio | Only 1 participant was enrolled in this study, due to the possibility of identification, data will not be presented. | Posted | Total study duration, anticipated 1 year |
|
|
| Secondary | Modified Dialysis Symptom Index Score | Only 1 participant was enrolled in this study, due to the possibility of identification, data will not be presented. | Posted | Study day 0, 7, 14, 28, and 90 |
|
|
| Secondary | Kidney Disease Quality of Life-36 Score | Only 1 participant was enrolled in this study, due to the possibility of identification, data will not be presented. | Posted | Study day 0, 7, 14, 28, and 90 |
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| 0 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |