Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2026-02-02 @ 3:37 AM
Study NCT ID:
NCT02371018
Status:
COMPLETED
Last Update Posted:
2018-08-02
First Post:
2015-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Effects of Nutrition Supplementation on Treatment Efficiency and Hemodynamics During Dialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-01', 'studyFirstSubmitDate': '2015-02-05', 'studyFirstSubmitQcDate': '2015-02-18', 'lastUpdatePostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in beat-to-beat systolic blood pressure', 'timeFrame': 'Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks', 'description': 'Beat-to-beat blood pressure will be monitored throughout the treatment by finger plethysmography'}], 'secondaryOutcomes': [{'measure': 'Gastrointestinal symptoms during treatment by a rating scale', 'timeFrame': 'Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks', 'description': 'A validated version of the Gastrointestinal Symptom Rating Scale will be administered'}, {'measure': 'Treatment efficiency measured by urea removal', 'timeFrame': 'Duration of each treatment (approximately four hours), treatments will be one week apart for a total of three weeks', 'description': 'Kt/V as determined from blood urea pre- and post-hemodialysis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Blood Pressure', 'Kidney Failure, Chronic', 'Dietary Modification']}, 'referencesModule': {'references': [{'pmid': '32390133', 'type': 'DERIVED', 'citation': 'Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effect of nutritional supplementation during hemodialysis treatment on beat-to-beat hemodynamics and treatment efficiency in a crossover design.', 'detailedDescription': 'The consumption of food or nutritional supplements during hemodialysis treatment has been shown to improve nutritional status, improve quality of life, and reduce mortality.\n\nDespite these observations, allowing patients to eat food during hemodialysis treatment is sometimes restricted in the United States. The reasons for this restrictive policy are multi-factorial, but include concerns related to drops in blood pressure BP or a reduced efficiency of solute removal following eating during HD treatment. An alternative to eating solid food is to provide patients with liquid nutritional supplements. Clinics in the US are more likely to allow the consumption of liquid nutritional supplements, however, little is known about the effect that liquid supplements have on blood pressure or treatment efficiency. Therefore, the investigators plan to examine the effect of nutritional supplementation during hemodialysis treatment on hemodynamics and treatment efficiency in a crossover design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receiving hemodialysis treatment three times per week, on hemodialysis for greater than three months, receive medical clearance from a Nephrologists\n\nExclusion Criteria:\n\n* Milk or soy allergy, more than 4 hypotensive events requiring intervention in the last two weeks, hospitalized due to hypotension in the previous week'}, 'identificationModule': {'nctId': 'NCT02371018', 'briefTitle': 'Acute Effects of Nutrition Supplementation on Treatment Efficiency and Hemodynamics During Dialysis', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Urbana-Champaign'}, 'officialTitle': 'Acute Effects of Nutrition Supplementation on Treatment Efficiency and Hemodynamics During Dialysis', 'orgStudyIdInfo': {'id': '14385'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard Hemodialysis', 'description': 'Participants will be monitored during their normal hemodialysis treatment with no intervention administered'}, {'type': 'EXPERIMENTAL', 'label': 'Hemodialysis with Nutrition Supplement', 'description': 'Participants will be monitored during a normal hemodialysis treatment in which they consume 1-8oz can of Nepro.', 'interventionNames': ['Dietary Supplement: Nepro']}, {'type': 'EXPERIMENTAL', 'label': 'Nutrition Supplement', 'description': 'Participants will be monitored while drinking 1-8oz can of Nepro with no hemodialysis treatment.', 'interventionNames': ['Dietary Supplement: Nepro']}], 'interventions': [{'name': 'Nepro', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients will be asked to consume a single 8 oz can of Nepro', 'armGroupLabels': ['Hemodialysis with Nutrition Supplement', 'Nutrition Supplement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}], 'overallOfficials': [{'name': 'Kenneth R Wilund, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Urbana-Champaign'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Urbana-Champaign', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}