Trial Outcomes & Findings for Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease (NCT NCT03141905)

NCT ID: NCT03141905

Last Updated: 2021-04-14

Results Overview

Laboratory measurement of creatinine at study entry and completion

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 342 participants
• Primary outcome timeframe: 6 months (enrollment to study completion)
• Results posted on: 2021-04-14

Participant Flow

Participant milestones

Measure	Sick-Day Protocol 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	Usual Care Usual Care: Standard clinical care
Overall Study STARTED	176	166
Overall Study COMPLETED	152	147
Overall Study NOT COMPLETED	24	19

Reasons for withdrawal

Measure	Sick-Day Protocol 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	Usual Care Usual Care: Standard clinical care
Overall Study Death	3	2
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	3	7
Overall Study Randomized, but did not receive intervention. Withdrew prior to baseline visit.	17	10

Baseline Characteristics

Baseline creatinine/eGFR missing for 4 study participants, 3 in the usual care arm, and 1 in the intervention arm.

Baseline characteristics by cohort

Measure	Sick-Day Protocol n=159 Participants 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	Usual Care n=156 Participants Usual Care: Standard clinical care	Total n=315 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=159 Participants	0 Participants n=156 Participants	0 Participants n=315 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=159 Participants	37 Participants n=156 Participants	66 Participants n=315 Participants
Age, Categorical >=65 years	130 Participants n=159 Participants	119 Participants n=156 Participants	249 Participants n=315 Participants
Sex: Female, Male Female	7 Participants n=159 Participants	7 Participants n=156 Participants	14 Participants n=315 Participants
Sex: Female, Male Male	152 Participants n=159 Participants	149 Participants n=156 Participants	301 Participants n=315 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=159 Participants	1 Participants n=156 Participants	2 Participants n=315 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	158 Participants n=159 Participants	155 Participants n=156 Participants	313 Participants n=315 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=159 Participants	0 Participants n=156 Participants	0 Participants n=315 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=159 Participants	0 Participants n=156 Participants	0 Participants n=315 Participants
Race (NIH/OMB) Asian	0 Participants n=159 Participants	1 Participants n=156 Participants	1 Participants n=315 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=159 Participants	0 Participants n=156 Participants	1 Participants n=315 Participants
Race (NIH/OMB) Black or African American	100 Participants n=159 Participants	99 Participants n=156 Participants	199 Participants n=315 Participants
Race (NIH/OMB) White	58 Participants n=159 Participants	56 Participants n=156 Participants	114 Participants n=315 Participants
Race (NIH/OMB) More than one race	0 Participants n=159 Participants	0 Participants n=156 Participants	0 Participants n=315 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=159 Participants	0 Participants n=156 Participants	0 Participants n=315 Participants
Region of Enrollment United States	159 participants n=159 Participants	156 participants n=156 Participants	315 participants n=315 Participants
eGFR	43.110 ml/min/1.73m^2 STANDARD_DEVIATION 13.128 • n=158 Participants • Baseline creatinine/eGFR missing for 4 study participants, 3 in the usual care arm, and 1 in the intervention arm.	43.783 ml/min/1.73m^2 STANDARD_DEVIATION 13.018 • n=153 Participants • Baseline creatinine/eGFR missing for 4 study participants, 3 in the usual care arm, and 1 in the intervention arm.	43.441 ml/min/1.73m^2 STANDARD_DEVIATION 13.057 • n=311 Participants • Baseline creatinine/eGFR missing for 4 study participants, 3 in the usual care arm, and 1 in the intervention arm.

PRIMARY outcome

Timeframe: 6 months (enrollment to study completion)

Population: 280 participants with complete laboratory data collection

Laboratory measurement of creatinine at study entry and completion

Outcome measures

Measure	Sick-Day Protocol n=140 Participants 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	Usual Care n=140 Participants Usual Care: Standard clinical care
Change in Renal Function From Baseline to Study Completion;	0.01 mg/dL Interval -0.11 to 0.22	0.02 mg/dL Interval -0.01 to 0.21

SECONDARY outcome

Timeframe: 6 months (enrollment to study completion)

Participants with abrupt changes in renal function as determined by EHR post-study review of new AKI ICD-10 codes, and for-cause lab ambulatory lab testing using RIFLE criteria

Outcome measures

Measure	Sick-Day Protocol n=159 Participants 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	Usual Care n=156 Participants Usual Care: Standard clinical care
Acute Kidney Injury Incidents 50% increase in Creatinine	1 Participants	0 Participants
Acute Kidney Injury Incidents AKI ICD-10 code on ED visit or admission	4 Participants	4 Participants

SECONDARY outcome

Timeframe: 6 months (enrollment to study completion)

Participants with urgent service utilization including emergency department, hospitalization, and urgent care.

Outcome measures

Measure	Sick-Day Protocol n=159 Participants 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	Usual Care n=156 Participants Usual Care: Standard clinical care
ER Use and Hospitalization Hospitalization	29 Participants	23 Participants
ER Use and Hospitalization Emergency Room	35 Participants	30 Participants
ER Use and Hospitalization Urgent Care	5 Participants	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months from enrollment in study

Population: 299 participants who completed all study visits.

Participants reporting sick-days via IVSDRS and end-of study visit survey ascertainment.

Outcome measures

Measure	Sick-Day Protocol n=152 Participants 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	Usual Care n=147 Participants Usual Care: Standard clinical care
Determination of Sick-day Incidents	29 Participants	20 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months (enrollment to study completion)

Population: Sick-Day Protocol group

Frequency of Sick-Day qualifying illnesses reported. (Note: this outcome is N/A for the usual care group)

Outcome measures

Measure	Sick-Day Protocol n=159 Participants 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	Usual Care Usual Care: Standard clinical care
Adherence to the Self-management Sick-day Protocol Followed Sick-Day Protocol instructions	14 count of qualifying illnesses	—
Adherence to the Self-management Sick-day Protocol Did not stop medicines	12 count of qualifying illnesses	—
Adherence to the Self-management Sick-day Protocol Stopped other medicines in addition to SDP qualifying.	6 count of qualifying illnesses	—

Adverse Events

Sick-Day Protocol

Serious events: 0 serious events

Other events: 7 other events

Deaths: 3 deaths

Usual Care

Serious events: 0 serious events

Other events: 3 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sick-Day Protocol n=159 participants at risk 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	Usual Care n=156 participants at risk Usual Care: Standard clinical care
Renal and urinary disorders Initiation of Hemodialysis	0.63% 1/159 • Number of events 1 • 6 months	0.64% 1/156 • Number of events 1 • 6 months
Endocrine disorders Lab Alert: Glucose ≥ 499 mg/dL	0.63% 1/159 • Number of events 1 • 6 months	1.3% 2/156 • Number of events 2 • 6 months
Cardiac disorders Lab Alert: Potassium ≥ 6.1 mEq/dL	1.9% 3/159 • Number of events 3 • 6 months	0.64% 1/156 • Number of events 1 • 6 months
Blood and lymphatic system disorders Lab Alert: Hemoglobin ≤ 7.5 g/dL	0.63% 1/159 • Number of events 1 • 6 months	0.00% 0/156 • 6 months
Renal and urinary disorders Lab Alert: Chloride ≥ 115 mEq/dL	1.3% 2/159 • Number of events 2 • 6 months	0.00% 0/156 • 6 months
Renal and urinary disorders Lab Alert: Co2 ≤ 15 mEq/L	0.63% 1/159 • Number of events 1 • 6 months	0.00% 0/156 • 6 months

Additional Information

Jeffrey C. Fink MD, MS (Principal Investigator)

University of Maryland, Baltimore

Phone: 410-328-4822

Email: jfink@som.umaryland.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place