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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meals | Experimental | High-protein renal-specific meals |
|
| Control | No Intervention | No Meals |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meals | Dietary Supplement | High Protein renal-specific meals |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypotensive Event Frequency | frequency of hypotensive events that require intervention during dialysis | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Arterial Pressure (mm Hg) | Average Lowest Mean Arterial Pressure (mm Hg) over 25 dialysis sessions during the study. | 9 weeks |
| Serum Albumin | 9 weeks |
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Inclusion Criteria:
Exclusion Criteria:
• Patients with dysphagia that cannot be accommodated by texture modifications, or those exclusively NPO/requiring tube feeding or parenteral feeding
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen M Hill Gallant, PhD | Purdue University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Purdue University | West Lafayette | Indiana | 47907 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30107974 | Result | Choi MS, Kistler B, Wiese GN, Stremke ER, Wright AJ, Moorthi RN, Moe SM, Hill Gallant KM. Pilot Study of the Effects of High-Protein Meals During Hemodialysis on Intradialytic Hypotension in Patients Undergoing Maintenance Hemodialysis. J Ren Nutr. 2019 Mar;29(2):102-111. doi: 10.1053/j.jrn.2018.06.002. Epub 2018 Aug 11. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Meeting abstract | View IPD |
De-identified individual participate data is available to other researchers upon reasonable request.
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| ID | Title | Description |
|---|---|---|
| FG000 | Meals | High-protein renal-specific meals Meals: High Protein renal-specific meals |
| FG001 | Control | No Meals |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Meals | High-protein renal-specific meals Meals: High Protein renal-specific meals |
| BG001 | Control | No Meals |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hypotensive Event Frequency | frequency of hypotensive events that require intervention during dialysis | Posted | Number | events | 9 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Meals | High-protein renal-specific meals Meals: High Protein renal-specific meals |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathleen Hill Gallant | Purdue University | 765-494-0101 | hillgallant@purdue.edu |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D062407 | Meals |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Blood Urea Nitrogen | 9 weeks |
| Serum Creatinine | 9 weeks |
| Blood Glucose | 9 weeks |
| Serum Adjusted Calcium | 9 weeks |
| Serum Sodium | 9 weeks |
| Serum Phosphate | 9 weeks |
| Serum Chloride | 9 weeks |
| Serum CO2 | 9 weeks |
| Serum Pre-albumin | 9 weeks |
| Dialysis Absences | Absences out of 25 sessions | 9 weeks |
| Interdialytic Weight Gain | 9 weeks |
| Vitality Score | Vitality measured by SF-36 (Short Form 36 Health Survey) Questionnaire. Minimum-Maximum values 0-100, with higher scores meaning better outcomes. | 9 weeks |
| Sleep Problems Index | Sleep Problems Index-II from the Medical Outcomes Study (MOS) Sleep Scale. Minimum-Maximum values 0-100, with higher scores meaning better outcomes. | 9 weeks |
| Hunger Rating | Hunger rating on a visual analog scale of 0-10 cm. Higher values mean a better outcome. | 9 weeks |
Abstract presented as a poster at the ASN Kidney Week 2016 (TH-PO762) |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index, kg/m^2 | Mean | Standard Deviation | kg/m^2 |
|
| Years on Dialysis | Mean | Standard Deviation | years |
|
|
| Secondary | Mean Arterial Pressure (mm Hg) | Average Lowest Mean Arterial Pressure (mm Hg) over 25 dialysis sessions during the study. | Posted | Mean | Standard Deviation | mm Hg | 9 weeks |
|
|
|
| Secondary | Serum Albumin | Posted | Mean | Standard Deviation | g/dL | 9 weeks |
|
|
|
| Secondary | Blood Urea Nitrogen | Posted | Mean | Standard Deviation | mg/dL | 9 weeks |
|
|
|
| Secondary | Serum Creatinine | Posted | Mean | Standard Deviation | mg/dL | 9 weeks |
|
|
|
| Secondary | Blood Glucose | Only measured in patients with diabetes mellitus | Posted | Mean | Standard Deviation | mg/dL | 9 weeks |
|
|
|
| Secondary | Serum Adjusted Calcium | Posted | Mean | Standard Deviation | mg/dL | 9 weeks |
|
|
|
| Secondary | Serum Sodium | Posted | Mean | Standard Deviation | mEq/L | 9 weeks |
|
|
|
| Secondary | Serum Phosphate | Posted | Mean | Standard Deviation | mg/dL | 9 weeks |
|
|
|
| Secondary | Serum Chloride | Posted | Mean | Standard Deviation | mEq/L | 9 weeks |
|
|
|
| Secondary | Serum CO2 | Posted | Mean | Standard Deviation | mEq/L | 9 weeks |
|
|
|
| Secondary | Serum Pre-albumin | Posted | Mean | Standard Deviation | mg/dL | 9 weeks |
|
|
|
| Secondary | Dialysis Absences | Absences out of 25 sessions | Posted | Mean | Standard Deviation | absences | 9 weeks |
|
|
|
| Secondary | Interdialytic Weight Gain | Posted | Mean | Standard Deviation | kg | 9 weeks |
|
|
|
| Secondary | Vitality Score | Vitality measured by SF-36 (Short Form 36 Health Survey) Questionnaire. Minimum-Maximum values 0-100, with higher scores meaning better outcomes. | Posted | Mean | Standard Deviation | score on a scale | 9 weeks |
|
|
|
| Secondary | Sleep Problems Index | Sleep Problems Index-II from the Medical Outcomes Study (MOS) Sleep Scale. Minimum-Maximum values 0-100, with higher scores meaning better outcomes. | Posted | Mean | Standard Deviation | score on a scale | 9 weeks |
|
|
|
| Secondary | Hunger Rating | Hunger rating on a visual analog scale of 0-10 cm. Higher values mean a better outcome. | Posted | Mean | Standard Deviation | units on a scale | 9 weeks |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Control | No Meals | 0 | 9 | 0 | 9 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |