N/A
N=342
Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease
Safety Issues · Chronic Kidney Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03141905 ↗Enrolled (actual)
342
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Change in Renal Function From Baseline to Study Completion; — 0.01; 0.02 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sick-Day Protocol (Other); Usual Care (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Renal Function From Baseline to Study Completion; |
0.01; 0.02 | — |
| SECONDARY Acute Kidney Injury Incidents |
4; 4; 1; 0 | — |
| SECONDARY ER Use and Hospitalization |
29; 23; 35; 30; 5; 5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Veterans with prescription for any type of RAS blocker, diuretic, Metformin or NSAID
Exclusion Criteria
- Expected death or dialysis within 6 months
- No home or cellular telephone
Data sourced from ClinicalTrials.gov (NCT03141905). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.