Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2026-02-28 @ 8:32 PM
Study NCT ID:
NCT05593627
Status:
RECRUITING
Last Update Posted:
2023-07-18
First Post:
2022-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Lithium Carbonate on Postoperative Sleep and Cognitive Function in Patients Undergoing Heart Valve Surgery With Cardiopulmonary Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016651', 'term': 'Lithium Carbonate'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'D002119', 'term': 'Calcium Carbonate'}], 'ancestors': [{'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D018020', 'term': 'Lithium Compounds'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D008903', 'term': 'Minerals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-14', 'studyFirstSubmitDate': '2022-10-21', 'studyFirstSubmitQcDate': '2022-10-21', 'lastUpdatePostDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cognitive function', 'timeFrame': 'on the seventh postoperative day', 'description': 'Mini-Mental State Examination (MMSE) score was performed'}], 'primaryOutcomes': [{'measure': 'sleep quality', 'timeFrame': 'on the second postoperative night from 20:00 to 6:00', 'description': 'Duration of sleep was collected with polysomnography on second postoperative night. (from 20:00pm to 06:00am)'}], 'secondaryOutcomes': [{'measure': 'serum metabolites', 'timeFrame': 'from baseline to postoperative 72 hours', 'description': 'This study will characterize the serum metabolites of patients before and after heart valve surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lithium carbonate', 'polysomnography'], 'conditions': ['Heart Valve Surgery']}, 'descriptionModule': {'briefSummary': 'It has been proved that lithium carbonate can prolong slow wave sleep with few or no side-effects. The aim of the present study is to evaluate postoperative sleep quality of patients undergoing heart valve surgery with cardiopulmonary bypass taken 250mg lithium carbonate after surgery.', 'detailedDescription': 'This study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All patients undergoing heart valve surgery with cardiopulmonary bypass will be randomized 1:1 to the treatment intervention with lithium carbonate 250mg (Baoqing, Hunan, China) or calcium carbonate 500mg (Reneed, Beijing, China) after surgery. The objective of the trial is to evaluate the lithium carbonate 250mg on the postoperative night sleep quality. Duration of sleep was collected with polysomnography on second postoperative night. (from 20:00pm to 06:00. Mini-Mental State Examination (MMSE) score was performed on the seventh postoperative day'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ethnic Chinese;\n* Age, 18 to 65 years old;\n* Patients undergoing heart valve surgery with cardiopulmonary bypass\n\nExclusion Criteria:\n\n* Preoperative Pittsburgh Sleep Quality Index global scores higher than 6\n* Cognitive difficulties\n* Partial or complete gastrectomy\n* Previous esophageal surgery\n* Previous treated by radiotherapy or surgery\n* Inability to conform to the study's requirements\n* Body mass index exceeding 30 kg/m2\n* Deprivation of a right to decide by an administrative or juridical entity\n* Ongoing participation or participation in another study \\<1 month ago\n* Recent (\\< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or traditional Chinese medicine"}, 'identificationModule': {'nctId': 'NCT05593627', 'briefTitle': 'Effect of Lithium Carbonate on Postoperative Sleep and Cognitive Function in Patients Undergoing Heart Valve Surgery With Cardiopulmonary Bypass', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University, China'}, 'officialTitle': 'Effect of Lithium Carbonate on Postoperative Sleep and Cognitive Function in Patients Undergoing Heart Valve Surgery With Cardiopulmonary Bypass', 'orgStudyIdInfo': {'id': '20220920-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lithium carbonate', 'description': 'Patients undergoing heart valve surgery with cardiopulmonary bypass will take 250mg lithium carbonate .', 'interventionNames': ['Drug: Lithium Carbonate 250 MG Oral Tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'calcium carbonate', 'description': 'Patients undergoing heart valve surgery with cardiopulmonary bypass will take 500mg calcium carbonate.', 'interventionNames': ['Drug: Calcium Carbonate 500 MG Oral Tablet']}], 'interventions': [{'name': 'Lithium Carbonate 250 MG Oral Tablet', 'type': 'DRUG', 'description': 'Patients undergoing heart valve surgery withcardiopulmonary bypass will take 250mg lithium carbonate', 'armGroupLabels': ['lithium carbonate']}, {'name': 'Calcium Carbonate 500 MG Oral Tablet', 'type': 'DRUG', 'description': 'Patients undergoing heart valve surgery withcardiopulmonary bypass will take 500mg calcium carbonate', 'armGroupLabels': ['calcium carbonate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110001', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenfei Tan, M.D.,Ph.D', 'role': 'CONTACT', 'email': 'winfieldtan@hotmail.com', 'phone': '024-83283100'}], 'facility': 'the First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'Wenfei Tan', 'role': 'CONTACT', 'email': 'winfieldtan@hotmail.com', 'phone': '024-83283100'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Wenfei Tan', 'investigatorAffiliation': 'China Medical University, China'}}}}