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Completed

NCT Number: NCT02917278

Pilot Study of Nutrition in Maintenance Hemodialysis Patients

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.

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Key information

Conditions

End-stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodialysis Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Meals Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University

West Lafayette, Indiana, 47907, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meals

Dietary Supplement

High Protein renal-specific meals

Primary outcomes

  1. Hypotensive Event Frequency

    Time frame: 9 weeks

    frequency of hypotensive events that require intervention during dialysis

Secondary outcomes

  1. Mean Arterial Pressure (mm Hg)

    Time frame: 9 weeks

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

  2. Serum Albumin

    Time frame: 9 weeks

  3. Blood Urea Nitrogen

    Time frame: 9 weeks

  4. Serum Creatinine

    Time frame: 9 weeks

  5. Blood Glucose

    Time frame: 9 weeks

  6. Serum Adjusted Calcium

    Time frame: 9 weeks

  7. Serum Sodium

    Time frame: 9 weeks

  8. Serum Phosphate

    Time frame: 9 weeks

  9. Serum Chloride

    Time frame: 9 weeks

  10. Serum CO2

    Time frame: 9 weeks

  11. Serum Pre-albumin

    Time frame: 9 weeks

  12. Dialysis Absences

    Time frame: 9 weeks

    Absences out of 25 sessions

  13. Interdialytic Weight Gain

    Time frame: 9 weeks

  14. Vitality Score

    Time frame: 9 weeks

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

  15. Sleep Problems Index

    Time frame: 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.

  16. Hunger Rating

    Time frame: 9 weeks

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

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 28, 2016
Registry last updated
Oct 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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