CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 342 enrolled
Drug / intervention
Sick-Day Protocol +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03141905
NCT03141905N/ACompleted

Can a Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease?

University of Maryland, Baltimore·interventional·Posted May 5, 2017·Updated Apr 14, 2021

In Brief

A clinical study evaluating Sick-Day Protocol and Usual Care for Safety Issues and Chronic Kidney Diseases. Completed, enrolled 342 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMay 5, 2017
Enrollment StartOct 16, 2017
Primary CompletionOct 7, 2020
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 9.2 years ago

Interventions

Sick-Day Protocolother

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

Usual Careother

Standard clinical care