N/A
Completed N=19
Pilot Study of Nutrition in Maintenance Hemodialysis Patients
End Stage Renal Disease · Meals · Hemodialysis
Source: ClinicalTrials.gov NCT02917278 ↗
Enrolled (actual)
19
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Hypotensive Event Frequency — 18; 13 events
Summary
This pilot study aims to produce preliminary data on the safety of providing high-protein meals to patients during dialysis, and effects of this intervention on nutritional status and quality of life outcomes. This is a non-randomized, parallel arm study. Meals provided will follow recommended dietary guidelines for HD patients and will provide approximately 1/3 of daily recommended protein intake. Patients will be allocated to either the treatment or control group by HD shift schedule. 2 months of baseline data will be collected, followed by 9 weeks of meal intervention/control and data collection. The primary outcome will be frequency of hypotensive events during dialysis requiring intervention. Secondary outcomes will include highest and lowest systolic blood pressure during dialysis, blood biochemistries including measures of renal function, nutritional status, and electrolyte balance; dialysis compliance; fluid retention; sleep and other quality of life measures; and dietary intake data.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hypotensive Event Frequency |
18; 13 | — |
| SECONDARY Mean Arterial Pressure (mm Hg) |
75; 84 | — |
| SECONDARY Serum Albumin |
3.7; 3.8 | — |
| SECONDARY Blood Urea Nitrogen |
49; 59 | — |
| SECONDARY Serum Creatinine |
6.8; 7.8 | — |
| SECONDARY Blood Glucose |
137; 178 | — |
| SECONDARY Serum Adjusted Calcium |
9.3; 9.3 | — |
| SECONDARY Serum Sodium |
138; 137 | — |
| SECONDARY Serum Phosphate |
5.2; 7.0 | — |
| SECONDARY Serum Chloride |
100; 98 | — |
| SECONDARY Serum CO2 |
25; 25 | — |
| SECONDARY Serum Pre-albumin |
26; 26 | — |
| SECONDARY Dialysis Absences |
0.9; 1.8 | — |
| SECONDARY Interdialytic Weight Gain |
1.8; 2.4 | — |
| SECONDARY Vitality Score |
42.94; 42.04 | — |
| SECONDARY Sleep Problems Index |
49.04; 43.37 | — |
| SECONDARY Hunger Rating |
1.01; 3.20 | — |
Eligibility Criteria
Inclusion Criteria
- Men and women
- Any race
- Age 18 years or older
- Maintenance hemodialysis patients
Exclusion Criteria
- Patients with dysphagia that cannot be accommodated by texture modifications, or those exclusively NPO/requiring tube feeding or parenteral feeding
Data sourced from ClinicalTrials.gov (NCT02917278). 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. Informational only — not medical advice.