Outpatient Recovery From Acute Kidney Injury Requiring Dialysis - 2

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

Providing additional information to patients with acute kidney injury who continue dialysis after hospital discharge and to the accepting kidney doctor (nephrologist) who manages their dialysis may be feasible and beneficial. This study will pilot measuring the patient's residual kidney function at the time of discharge and communicating that result to the accepting nephrologist and the patient, along with information on recommended recovery monitoring frequency and criteria for consideration of a twice-weekly hemodialysis schedule.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

AKI-D (not ESKD, as determined by the clinical inpatient nephrology team)

Age ≥ 18 years

Planned for continued dialysis outside the acute hospital setting (at outpatient dialysis unit/SNF/LTACH, not planned transfer to another short-stay acute care hospital).

Disqualifiers

Pregnant

Prisoner

Unable to consent and no surrogate decision maker available

Clinical team declines to allow approach for study

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transmission of additional AKI-D recovery information

    Behavioral

    Measuring residual kidney function at the time of hospital discharge by timed urine collection (6-24 hours in duration), transmitting the results (urine volume, urea clearance, and creatinine clearance) to the accepting nephrologist and to the patient, along with information on recommended recovery monitoring frequency and criteria for consideration of a twice-weekly hemodialysis schedule.

  • No additional AKI-D recovery information

    Other intervention

    The same timed urine collection will be collected at the time of hospital discharge as in the intervention arm, but in the control arm the results will not be transmitted to the accepting nephrologist or to the patient and no information on recommended recovery monitoring frequency and criteria for consideration of a twice-weekly hemodialysis schedule will be transmitted. Instead, the research team will call the accepting nephrologist to alert them that this is an AKI-D patient that is being followed by the research team for recovery for up to 60 days.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Additional AKI-D recovery informationExperimental treatment 1 intervention
Group B: No additional AKI-D recovery informationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility: The proportion of patients who complete the timed urine collection within seven days before discharge and are able to have the results successfully transmitted to the accepting nephrologist and patient.

Time frame
Baseline

Secondary outcomes

1

Recruitment rate: Number of patients enrolled per month

Time frame
Total study duration, anticipated 2 years
2

Screening-to-recruitment ratio: Number of patients who meet inclusion criteria divided by the number of patients enrolled.

Time frame
Total study duration, anticipated 2 years
3

Number of post-discharge urine collections completed

Time frame
Study day 60
4

Proportion prescribed a <3x/wk hemodialysis schedule at any time within 60 days of hospital discharge

Time frame
Study day 60

Other outcomes

Sponsors and contacts

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University of California, San Francisco

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator