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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003899-13 | EudraCT Number | ||
| NL65803.078.18 | Other Identifier | Central Commission for Human Research (CCMO) | |
| MEC-2018-1452 | Other Identifier | Erasmus MC |
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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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Protein-energy wasting (PEW), a hypercatabolic state characterized by loss of muscle mass and fuel reserves, is highly prevalent in hemodialysis patients. Nutritional status and body composition are closely linked to morbidity, mortality and quality of life. Lean tissue mass (LTM) appears to be the best read-out for the association between nutritional status and outcomes. Intradialytic parenteral nutrition (IDPN) is occasionally used with the aim to reduce loss of LTM, but its efficacy has not been established. The goal of this study is to study the effect of IDPN on changes in LTM in hemodialysis patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Intradialytic parenteral nutrition three times weekly during 16 weeks |
|
| Placebo | Placebo Comparator | 5% glucose three times weekly during 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olimel N12 | Drug | A mixture of glucose, lipids, amino acids. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lean tissue mass | Measured by body composition monitor (BCM) | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Skeletal muscle quality index (SMQI) | Assessed by muscle ultrasound | 16 weeks |
| Change in adipose tissue mass from baseline | 16 weeks | |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective global assessment (SGA) | 7-point scale, 7 indicates normal nutritional status, 1 indicates severe protein energy wasting | 16 weeks |
| Change in serum albumin concentration | 16 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ewout J Hoorn, MD PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC | Rotterdam | Netherlands | ||||
| Franciscus Gasthuis & Vlietland |
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| Glucose IV |
| Drug |
Glucose 5% |
|
| Change in hand grip strength from baseline |
Measured by hand dynamometer, expressed as percentile of reference (by age and gender) |
| 16 weeks |
| Change in kidney disease quality of life (KDQoL-36) energy/fatigue scale from baseline | Assessed by Kidney Disease Quality of Life-36 (KDQoL-36) survey (energy/fatigue scale, 0-100, higher is better) | 16 weeks |
| Change in kidney disease quality of life (KDQoL-36, overall health rating) from baseline | Assessed by Kidney Disease Quality of Life-36 (KDQoL-36) survey (0-100, higher is better) | 16 weeks |
| Positive and negative affect | Assessed by Positive and Negative Affect Schedule (PANAS, 0-100, higher is better) | 16 weeks |
| Change in phase angle from baseline | Assessed by Body Composition Monitor (BCM) | 16 weeks |
| Change in body weight from baseline | 16 weeks |
| Change in serum prealbumin concentration from baseline | 16 weeks |
| Appetite | Numeric rating scale (0-10, 10 being best appetite) | 16 weeks |
| Rotterdam |
| Netherlands |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D044342 | Malnutrition |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| 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 |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C574212 | 1-((2-hydroxyethyl)amino)-2-amino-1,2-dideoxyglucose triphenyltin(IV) |
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