Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-02-27 @ 10:33 AM
Study NCT ID:
NCT03511950
Status:
UNKNOWN
Last Update Posted:
2022-09-29
First Post:
2018-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between the Change of Resting Energy Expenditure and Nutritional Status .
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010538', 'term': 'Peritonitis'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-27', 'studyFirstSubmitDate': '2018-04-01', 'studyFirstSubmitQcDate': '2018-04-27', 'lastUpdatePostDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The relationship between the change of REE and the outcome of patients', 'timeFrame': '90 days or 180days', 'description': 'outcome including death and transfer to hemodialysis'}], 'primaryOutcomes': [{'measure': 'The relationship between the change of REE and the change of albumin', 'timeFrame': '90 days', 'description': 'Method: REE, indirect calorimetry'}], 'secondaryOutcomes': [{'measure': 'The relationship between the change of REE and the change of BMI', 'timeFrame': '90 days', 'description': 'The relationship between the change of REE and the change of BMI during 90 days after peritonitis'}, {'measure': 'The relationship between the change of REE and the change of handgrip strength', 'timeFrame': '90 days', 'description': 'The relationship between the change of REE and the change of handgrip strength during 90 days after peritonitis'}, {'measure': 'The relationship between the change of REE and the change of Fat mass', 'timeFrame': '90 days', 'description': 'Method: REE, indirect calorimetry; Fat mass, Bioelectrical impedance'}, {'measure': 'The relationship between the change of REE and the change of lean body mass', 'timeFrame': '90 days', 'description': 'Method: REE, indirect calorimetry; lean body mass, Bioelectrical impedance'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peritonitis', 'Resting Energy Expenditure', 'Nutrition']}, 'descriptionModule': {'briefSummary': 'Peritonitis is a common and devastating complication in patients on peritoneal dialysis (PD). It is a known fact that persistent inflammatory state and nutritional deterioration are closely associated with increased mortality in PD patients.And resting energy expenditure(REE) is significantly increased in acute and chronic inflammation in patients with chronic kidney disease (including dialysis patients).However,it is limited to the changing trend and duration of REE in peritonitis.Investigators hypothesize that the increase in total energy consumption resulting from the increase of REE which may accompany with decreased energy intake will lead to negative energy balance and nutritional deterioration, which may affect the prognosis of patients.Therefore,a prospective cohort study will be designed to dynamically research the change of REE accompanied with the nutrition status in peritonitis and provide the basis for peritonitis management in the future.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'PD patients with confirm diagnosis of peritonitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receiving PD for\\>3 months\n* Age between 18 and 80 years\n* Confirm diagnosis of peritonitis\n\nExclusion Criteria:\n\n* Disability\n* Other acute complications: including systemic infections except for peritonitis, acute cardia-cerebrovascular disease in one month\n* Active hepatitis and musculoskeletal diseases in the past\n* Cancer and is treated with chemoradiotherapy within 1 year\n* Severe edema of the whole body or a large amount of body cavity effusion\n* Thyroid dysfunction\n* History of hormonal drugs use\n* During pregnancy or lactation\n* Mental disorder'}, 'identificationModule': {'nctId': 'NCT03511950', 'briefTitle': 'The Relationship Between the Change of Resting Energy Expenditure and Nutritional Status .', 'organization': {'class': 'OTHER', 'fullName': 'Peking University First Hospital'}, 'officialTitle': 'The Relationship Between the Change of Resting Energy Expenditure(REE) and Nutritional Status in Peritoneal Dialysis(PD) Patients With Peritonitis.', 'orgStudyIdInfo': {'id': 'REE and peritonitis'}}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jie Dong', 'role': 'CONTACT', 'email': 'jie.dong@bjmu.edu.cn', 'phone': '13911841538'}], 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jie Dong', 'role': 'CONTACT', 'email': 'jie.dong@bjmu.edu.cn', 'phone': '13911841538'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University First Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor in Renal Division, Department of Medicine', 'investigatorFullName': 'Dong Jie', 'investigatorAffiliation': 'Peking University First Hospital'}}}}