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Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease

NCT03141905 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2021-04-14

Study results available
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Summary

The benefits of renin angiotensin system (RAS) blockers and diuretics for blood pressure control are well-established in chronic kidney diseases (CKD) patients; however, these agents may become hazardous on "sick-days" that lead to volume depletion (dehydration), and increase the risk of kidney function loss and acute kidney injury (AKI). It is not known how frequent significant sick-days occur in CKD patients, or whether a patient self-managed Sick-Day Protocol (SDP) that temporarily holds RAS blocker, diuretics, or other high risk medication in an effort to preserve renal function, or prevent AKI. The purpose of the study is to asses if a SDP, monitored remotely with a weekly automated phone survey , can improve outcomes in CKD (such as slow renal function loss and AKI episodes) and reduce preventable service utilization versus usual care.

Conditions

  • Safety Issues
  • Chronic Kidney Diseases

Interventions

OTHER

Sick-Day Protocol

Sick-Day Protocol (instructions for holding and resumption of certain medicines in the event of dehydrating illness) and IVSDRS weekly remote monitoring

OTHER

Usual Care

Standard clinical care

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-16
Primary Completion
2020-10-07
Completion
2020-10-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03141905 on ClinicalTrials.gov