Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2025-12-29 @ 2:12 AM
Study NCT ID:
NCT00438295
Status:
COMPLETED
Last Update Posted:
2015-09-15
First Post:
2007-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Temperature Control During Dialysis Treatment
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-14', 'studyFirstSubmitDate': '2007-02-20', 'studyFirstSubmitQcDate': '2007-02-21', 'lastUpdatePostDateStruct': {'date': '2015-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of temperature control on blood pressure, pulse rate and blod glucose during dialysis treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['glucose in dialysis water, dialysis treatment, temperature'], 'conditions': ['Renal Failure, Chronic']}, 'descriptionModule': {'briefSummary': 'The purpose is to measure the effect of glucose in the dialysis water on blood pressure, pulse rate, and plasma glucose with and without body temperature control', 'detailedDescription': 'To clarify the influence of temperature in dialysis water on blood pressure and vasoactive hormones'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\> 18 years,\n2. both men and women,\n3. chronic renal failure and dialysis treatment for at least three months\n\nExclusion Criteria:\n\n1. Heart failure,\n2. Lung insufficiency,\n3. Chronic liver disease,\n4. Diabetes mellitus,\n5. Malignant disease,\n6. Nephrotic syndrome,\n7. Lack of compliance,\n8. Unwillingness til participate'}, 'identificationModule': {'nctId': 'NCT00438295', 'briefTitle': 'Temperature Control During Dialysis Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Regional Hospital Holstebro'}, 'officialTitle': 'Effect of Temperature Control During Dialysis Treatment With Glucose in Dialysis Water in Patients With Chronic Renal Failure', 'orgStudyIdInfo': {'id': 'MED.RES.2007.03.EBP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'temperature control', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '7500', 'city': 'Holstebro', 'country': 'Denmark', 'facility': 'Holstebro Hospital', 'geoPoint': {'lat': 56.36009, 'lon': 8.61607}}], 'overallOfficials': [{'name': 'Erling B Pedersen, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Regional Hospital Holstebro'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regional Hospital Holstebro', 'class': 'OTHER'}}}}