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Recruiting NCT07106151

Outpatient Recovery From Acute Kidney Injury Requiring Dialysis - 2

No phase Interventional AKI AKI - Acute Kidney Injury Dialysis Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transmission of additional AKI-D recovery information, No additional AKI-D recovery information.
Who it may be relevant to
Registry conditions: AKI, AKI - Acute Kidney Injury, Dialysis Patients. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Behavioral Transmission of additional AKI-D recovery information
    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.
  • Other No additional AKI-D recovery information
    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 fol

Primary outcome measures

  • 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 outcome measures (7)
  • Recruitment rate: Number of patients enrolled per month [Time frame: Total study duration, anticipated 2 years]
  • 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]
  • Number of post-discharge urine collections completed [Time frame: Study day 60]
  • Proportion prescribed a <3x/wk hemodialysis schedule at any time within 60 days of hospital discharge [Time frame: Study day 60]
  • Proportion who recover from needing dialysis [Time frame: Study day 60]
  • Proportion who trial a <3x/wk hemodialysis schedule but subsequently need to be increased to >= 3x/wk during the 60-day follow-up. [Time frame: Study day 60]
  • Incidence of adverse events [Time frame: Study day 60]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • Pregnant
  • Prisoner
  • Unable to consent and no surrogate decision maker available
  • Clinical team declines to allow approach for study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • University of California, San Francisco — San Francisco

Identifiers

NCT: NCT07106151 · 25-44531 · 5K23DK128605

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗