Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-27 @ 6:20 AM
Study NCT ID:
NCT05797194
Status:
COMPLETED
Last Update Posted:
2023-04-04
First Post:
2023-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Association Between SIRI and POD in Older Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-03', 'studyFirstSubmitDate': '2023-03-05', 'studyFirstSubmitQcDate': '2023-04-03', 'lastUpdatePostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Confusion assessment method (CAM) score', 'timeFrame': 'Baseline (Before surgery)', 'description': 'Positive CAM score means that the patient developed postoperative delirium. While negative CAM score means that the patient did not develop postoperative delirium.'}, {'measure': 'CAM score', 'timeFrame': 'Postoperative day 1', 'description': 'Positive CAM score means that the patient developed postoperative delirium. While negative CAM score means that the patient did not develop postoperative delirium.'}, {'measure': 'CAM score', 'timeFrame': 'Postoperative day 2', 'description': 'Positive CAM score means that the patient developed postoperative delirium. While negative CAM score means that the patient did not develop postoperative delirium.'}, {'measure': 'CAM score', 'timeFrame': 'Postoperative day 3', 'description': 'Positive CAM score means that the patient developed postoperative delirium. While negative CAM score means that the patient did not develop postoperative delirium.'}], 'secondaryOutcomes': [{'measure': 'The level of systemic inflammation response index (SIRI) in peripheral blood.', 'timeFrame': 'Baseline (Before surgery)', 'description': 'The SIRI was calculated as neutrophil count × monocyte count/lymphocyte count.'}, {'measure': 'Mini-mental State Examination (MMSE) score', 'timeFrame': 'Baseline (Before surgery)', 'description': 'MMSE score ranges from 0 to 30 and higher score means better outcome.'}, {'measure': 'MMSE score', 'timeFrame': 'postoperative day 1', 'description': 'MMSE score ranges from 0 to 30 and higher score means better outcome.'}, {'measure': 'MMSE score', 'timeFrame': 'postoperative day 3', 'description': 'MMSE score ranges from 0 to 30 and higher score means better outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Delirium', 'Elderly', 'Surgery']}, 'descriptionModule': {'briefSummary': 'Postoperative delirium (POD) remains one of most common complication in elderly patients receiving surgery, which is characterized by acute and fluctuating change in the level of cognition and consciousness. Previous studies have shown that surgery and anesthesia-induced acute peripheral inflammation and neuroinflammation may lead to delirium after surgery. Systemic Inflammation Response Index (SIRI) is a more easily accessible and comprehensive inflammation marker derived from monocyte, neutrophil, and lymphocyte count, which has been investigated to assess the prognosis of cancer and infectious diseases. However, the relationship between SIRI and POD has yet to be investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible patients were scheduled to undergo elective orthopedics surgery under spinal anesthesia with an expected hospital stay of at least 3 days and received postoperative patient- controlled analgesia. Delirium was evaluated at the preoperative visit, then twice daily for 3 days following surgery. Cognition assessment was conducted at preoperative visit, 24 h after surgery and 72 h after surgery. Delirium assessments were performed before 10 AM and after 5 PM in the ward. The confusion assessment method (CAM) questionnaire and cognition assessment method for MMSE were performed by the qualified doctor who trained with CAM and MMSE training manual.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospital stay of at least 3 days\n* More than or equal to 65 years old\n* Elementary education or above\n* Able to communicate\n* American Society of Anesthesiologists (ASA) physical status I-III\n* Mini-mental State Examination (MMSE) scores ≥ 22 points\n\nExclusion Criteria:\n\n* Preoperative delirium\n* Severe mental diseases\n* Autoimmune-illness, chronic infectious diseases, nervous system diseases and malignancies'}, 'identificationModule': {'nctId': 'NCT05797194', 'briefTitle': 'The Association Between SIRI and POD in Older Patients', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'The Potential Value of Systemic Inflammation Response Index on Postoperative Delirium in Older Patients', 'orgStudyIdInfo': {'id': 'POD-SIRI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'POD group', 'description': 'Patients were considered to surfer from postoperative delirium by a positive Confusion Assessment Method (CAM) questionnaire after surgery.'}, {'label': 'No-POD group', 'description': 'Patients did not surfer from postoperative delirium by a positive CAM questionnaire after surgery.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}