Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease

NCT03141905 | Completed Results DMC

• 1 other identifier: HP-00069775
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

patient safety; self-management; remote monitoring

Outcome Measures

Primary Outcomes (1)

• Change in Renal Function From Baseline to Study Completion;

  Laboratory measurement of creatinine at study entry and completion

  6 months (enrollment to study completion)

Secondary Outcomes (2)

• Acute Kidney Injury Incidents

  6 months (enrollment to study completion)

• ER Use and Hospitalization

  6 months (enrollment to study completion)

Other Outcomes (2)

• Determination of Sick-day Incidents

  6 months from enrollment in study

• Adherence to the Self-management Sick-day Protocol

  6 months (enrollment to study completion)

Study Arms (2)

Sick-Day Protocol

ACTIVE COMPARATOR

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

Other: Sick-Day Protocol

Usual Care

PLACEBO COMPARATOR

Standard clinical care

Other: Usual Care

Interventions

Sick-Day Protocol OTHER

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

Sick-Day Protocol

Usual Care OTHER

Standard clinical care

Usual Care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans with prescription for any type of RAS blocker, diuretic, Metformin or NSAID

You may not qualify if:

• Expected death or dialysis within 6 months
• No home or cellular telephone

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Baltimore VA Medical Center

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• Fink JC, Maguire RM, Blakeman T, Tomlinson LA, Tomson C, Wagner LA, Zhan M. Medication Holds in CKD During Acute Volume-Depleting Illnesses: A Randomized Controlled Trial of a "Sick-Day" Protocol. Kidney Med. 2022 Jul 31;4(9):100527. doi: 10.1016/j.xkme.2022.100527. eCollection 2022 Sep.

  PMID: 36046613 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Due to the COVID-19 pandemic in-person visits were suspended on 3/12/2020 per institution and IRB mandate. Study lab measurements were delayed for 24 participants and not completed for 8 participants.

Results Point of Contact

• Title: Jeffrey C. Fink MD, MS (Principal Investigator)
• Organization: University of Maryland, Baltimore

jfink@som.umaryland.edu

410-328-4822

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Head, General Internal Medicine

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 5, 2017
• Study Start: October 16, 2017
• Primary Completion: October 7, 2020
• Study Completion: October 7, 2020
• Last Updated: April 14, 2021
• Results First Posted: April 14, 2021

Record last verified: 2021-03

Locations

US (1)