Trial Outcomes & Findings for Pilot Study of Nutrition in Maintenance Hemodialysis Patients (NCT NCT02917278)

NCT ID: NCT02917278

Last Updated: 2021-10-19

Results Overview

frequency of hypotensive events that require intervention during dialysis

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 19 participants
• Primary outcome timeframe: 9 weeks
• Results posted on: 2021-10-19

Participant Flow

Participant milestones

Measure	Meals High-protein renal-specific meals Meals: High Protein renal-specific meals	Control No Meals
Overall Study STARTED	10	9
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Meals n=9 Participants High-protein renal-specific meals Meals: High Protein renal-specific meals	Control n=9 Participants No Meals	Total n=18 Participants Total of all reporting groups
Age, Continuous	66.8 years STANDARD_DEVIATION 11.4 • n=9 Participants	58.1 years STANDARD_DEVIATION 19.2 • n=9 Participants	62.4 years STANDARD_DEVIATION 15.9 • n=18 Participants
Sex: Female, Male Female	5 Participants n=9 Participants	5 Participants n=9 Participants	10 Participants n=18 Participants
Sex: Female, Male Male	4 Participants n=9 Participants	4 Participants n=9 Participants	8 Participants n=18 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	9 participants n=9 Participants	9 participants n=9 Participants	18 participants n=18 Participants
Body Mass Index, kg/m^2	34.2 kg/m^2 STANDARD_DEVIATION 10.2 • n=9 Participants	31.1 kg/m^2 STANDARD_DEVIATION 8.0 • n=9 Participants	32.6 kg/m^2 STANDARD_DEVIATION 9.0 • n=18 Participants
Years on Dialysis	3.1 years STANDARD_DEVIATION 2.0 • n=9 Participants	3.6 years STANDARD_DEVIATION 3.3 • n=9 Participants	3.3 years STANDARD_DEVIATION 2.6 • n=18 Participants

PRIMARY outcome

Timeframe: 9 weeks

frequency of hypotensive events that require intervention during dialysis

Outcome measures

Measure	Meals n=9 Participants High-protein renal-specific meals Meals: High Protein renal-specific meals	Control n=9 Participants No Meals
Hypotensive Event Frequency	18 events	13 events

SECONDARY outcome

Timeframe: 9 weeks

Average Lowest Mean Arterial Pressure (mm Hg) over 25 dialysis sessions during the study.

Outcome measures

Measure	Meals n=9 Participants High-protein renal-specific meals Meals: High Protein renal-specific meals	Control n=9 Participants No Meals
Mean Arterial Pressure (mm Hg)	75 mm Hg Standard Deviation 8	84 mm Hg Standard Deviation 11

SECONDARY outcome

Timeframe: 9 weeks

Outcome measures

Measure	Meals n=9 Participants High-protein renal-specific meals Meals: High Protein renal-specific meals	Control n=9 Participants No Meals
Serum Albumin	3.7 g/dL Standard Deviation 0.3	3.8 g/dL Standard Deviation 0.3

SECONDARY outcome

Timeframe: 9 weeks

Outcome measures

Measure	Meals n=9 Participants High-protein renal-specific meals Meals: High Protein renal-specific meals	Control n=9 Participants No Meals
Blood Urea Nitrogen	49 mg/dL Standard Deviation 16	59 mg/dL Standard Deviation 13

SECONDARY outcome

Timeframe: 9 weeks

Outcome measures

Measure	Meals n=9 Participants High-protein renal-specific meals Meals: High Protein renal-specific meals	Control n=9 Participants No Meals
Serum Creatinine	6.8 mg/dL Standard Deviation 1.1	7.8 mg/dL Standard Deviation 4.4

SECONDARY outcome

Timeframe: 9 weeks

Population: Only measured in patients with diabetes mellitus

Outcome measures

Measure	Meals n=8 Participants High-protein renal-specific meals Meals: High Protein renal-specific meals	Control n=6 Participants No Meals
Blood Glucose	137 mg/dL Standard Deviation 55	178 mg/dL Standard Deviation 77

SECONDARY outcome

Timeframe: 9 weeks

Outcome measures

Measure	Meals n=9 Participants High-protein renal-specific meals Meals: High Protein renal-specific meals	Control n=9 Participants No Meals
Serum Adjusted Calcium	9.3 mg/dL Standard Deviation 0.4	9.3 mg/dL Standard Deviation 0.6

SECONDARY outcome

Timeframe: 9 weeks

Outcome measures

Measure	Meals n=9 Participants High-protein renal-specific meals Meals: High Protein renal-specific meals	Control n=9 Participants No Meals
Serum Sodium	138 mEq/L Standard Deviation 2	137 mEq/L Standard Deviation 3

SECONDARY outcome

Timeframe: 9 weeks

Outcome measures

Measure	Meals n=9 Participants High-protein renal-specific meals Meals: High Protein renal-specific meals	Control n=9 Participants No Meals
Serum Phosphate	5.2 mg/dL Standard Deviation 0.7	7.0 mg/dL Standard Deviation 1.7

SECONDARY outcome

Timeframe: 9 weeks

Outcome measures

Measure	Meals n=9 Participants High-protein renal-specific meals Meals: High Protein renal-specific meals	Control n=9 Participants No Meals
Serum Chloride	100 mEq/L Standard Deviation 2	98 mEq/L Standard Deviation 3

SECONDARY outcome

Timeframe: 9 weeks

Outcome measures

Measure	Meals n=9 Participants High-protein renal-specific meals Meals: High Protein renal-specific meals	Control n=9 Participants No Meals
Serum CO2	25 mEq/L Standard Deviation 1	25 mEq/L Standard Deviation 2

SECONDARY outcome

Timeframe: 9 weeks

Outcome measures

Measure	Meals n=9 Participants High-protein renal-specific meals Meals: High Protein renal-specific meals	Control n=9 Participants No Meals
Serum Pre-albumin	26 mg/dL Standard Deviation 7	26 mg/dL Standard Deviation 8

SECONDARY outcome

Timeframe: 9 weeks

Absences out of 25 sessions

Outcome measures

Measure	Meals n=9 Participants High-protein renal-specific meals Meals: High Protein renal-specific meals	Control n=9 Participants No Meals
Dialysis Absences	0.9 absences Standard Deviation 1.1	1.8 absences Standard Deviation 2.6

SECONDARY outcome

Timeframe: 9 weeks

Outcome measures

Measure	Meals n=9 Participants High-protein renal-specific meals Meals: High Protein renal-specific meals	Control n=9 Participants No Meals
Interdialytic Weight Gain	1.8 kg Standard Deviation 1.1	2.4 kg Standard Deviation 2.1

SECONDARY outcome

Timeframe: 9 weeks

Vitality measured by SF-36 (Short Form 36 Health Survey) Questionnaire. Minimum-Maximum values 0-100, with higher scores meaning better outcomes.

Outcome measures

Measure	Meals n=9 Participants High-protein renal-specific meals Meals: High Protein renal-specific meals	Control n=9 Participants No Meals
Vitality Score	42.94 score on a scale Standard Deviation 18.30	42.04 score on a scale Standard Deviation 11.99

SECONDARY outcome

Timeframe: 9 weeks

Sleep Problems Index-II from the Medical Outcomes Study (MOS) Sleep Scale. Minimum-Maximum values 0-100, with higher scores meaning better outcomes.

Outcome measures

Measure	Meals n=9 Participants High-protein renal-specific meals Meals: High Protein renal-specific meals	Control n=9 Participants No Meals
Sleep Problems Index	49.04 score on a scale Standard Deviation 10.2	43.37 score on a scale Standard Deviation 13.00

SECONDARY outcome

Timeframe: 9 weeks

Hunger rating on a visual analog scale of 0-10 cm. Higher values mean a better outcome.

Outcome measures

Measure	Meals n=9 Participants High-protein renal-specific meals Meals: High Protein renal-specific meals	Control n=9 Participants No Meals
Hunger Rating	1.01 units on a scale Standard Deviation 1.01	3.20 units on a scale Standard Deviation 1.89

Adverse Events

Meals

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kathleen Hill Gallant

Purdue University

Phone: 765-494-0101

Email: hillgallant@purdue.edu

Results disclosure agreements

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