Trial Outcomes & Findings for Outpatient Recovery From Acute Kidney Injury Requiring Dialysis (NCT NCT05158153)
NCT ID: NCT05158153
Last Updated: 2023-05-12
Results Overview
Feasibility
TERMINATED
PHASE4
1 participants
First two weeks of study intervention
2023-05-12
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Outpatient Recovery From Acute Kidney Injury Requiring Dialysis
Baseline characteristics by cohort
| Measure |
ORKID Bundled Intervention
n=1 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity
|
NA participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First two weeks of study interventionPopulation: Only 1 participant was enrolled in this study, due to the possibility of identification, data will not be presented.
Feasibility
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study day 90Population: Only 1 participant was enrolled in this study, due to the possibility of identification, data will not be presented.
Tolerability
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study day 90Population: Only 1 participant was enrolled in this study, due to the possibility of identification, data will not be presented.
Safety
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study day 90Population: Only 1 participant was enrolled in this study, due to the possibility of identification, data will not be presented.
Days after study enrollment before renal recovery, defined as being alive and off dialysis for 14 consecutive days.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study day 90Population: Only 1 participant was enrolled in this study, due to the possibility of identification, data will not be presented.
Defined as nadir systolic blood pressure \< 90 mmHg.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Total study duration, anticipated 1 yearPopulation: Only 1 participant was enrolled in this study, due to the possibility of identification, data will not be presented.
Recruitment rate
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Total study duration, anticipated 1 yearPopulation: Only 1 participant was enrolled in this study, due to the possibility of identification, data will not be presented.
Screening-to-recruitment ratio
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study day 0, 7, 14, 28, and 90Population: Only 1 participant was enrolled in this study, due to the possibility of identification, data will not be presented.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study day 0, 7, 14, 28, and 90Population: Only 1 participant was enrolled in this study, due to the possibility of identification, data will not be presented.
Outcome measures
Outcome data not reported
Adverse Events
ORKID Bundled Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place