Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2026-01-01 @ 9:46 PM
Study NCT ID:
NCT04596332
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2020-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Central Venous Pressure Monitoring and Prognosis of High-risk Operating Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 196}, 'targetDuration': '28 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-15', 'studyFirstSubmitDate': '2020-10-15', 'studyFirstSubmitQcDate': '2020-10-15', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Outcome', 'timeFrame': '28-day', 'description': '28-day mortality, length of stay in intensive care unit and hospitalization, surgical complications'}], 'secondaryOutcomes': [{'measure': 'Secondary Outcome', 'timeFrame': '1-day', 'description': 'Comparison of perioperative fluid management in each group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['perioperative', 'central venous pressure', 'fluid management', 'acute renal injury'], 'conditions': ['Central Venous Pressure']}, 'descriptionModule': {'briefSummary': 'While central venous pressure measurement is used to guide fluid management in high risk surgical patients during perioperative period, the relationship between the value of central venous pressure and organ dysfunction and prognosis of high-risk operating patients is unknow. In this study, we conducted a retrospective study of the relationship between the initial levels of CVP with organ dysfunction, the severity of illness, the length of ICU stay, and prognosis of critically ill patients.', 'detailedDescription': 'Although less than 15% of high-risk patients (elderly or with limited cardiopulmonary reserves) undergo surgery, these patients account for 80% of hospital deaths. The requirements for hemodynamic monitoring to critical patients during perioperative period reach are of maximal importance, for two major reasons: (i) absolute or relative volume deficiency often occurs in postoperative patients due to preoperative fasting, intraoperative bleeding and non-dominant fluid loss caused by vasodilation and fluid redistribution caused by anesthesia; (ii) insufficient fluid replacement may lead to increased postoperative organ complications and poor wound healing. Adequate and goal-oriented hemodynamic monitoring combined with early and appropriate treatment can improve the prognosis of high-risk surgical patients.\n\nCentral venous pressure is a localized parameter of the superior vena cava or the right atrium and is closely related to the right ventricular end-diastolic pressure. With volume overload, CVP levels may be abnormally elevated. Maintaining central venous pressure as low as possible is conducive to the recovery of internal organs during haemodynamic treatment, especially for the kidney, intestine, and brain, etc. However, elevated central venous pressure (CVP) occurs frequently in critical care settings, including postoperative critical patients. In this study, we conducted a retrospective study of the relationship between the initial levels of CVP with organ dysfunction, the severity of illness, the length of ICU stay, and prognosis of critically ill patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This is a single-center, retrospective, observational study enrolled 196 patients undergoing high-risk surgery who admitted to surgical intensive care unit(SICU) directly after operation from Feb 1,2014 to Mar 31,2018.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years.⑵ All patients undergoing surgery and admitted to our intensive care unit (ICU) directly after surgery were enrolled into the respective study.⑶ They stayed in the ICU more than 48 hours with central venous pressure monitored for more than 48 hours.\n\nExclusion Criteria:\n\n* Patients who were in pregnancy. ⑵Older than 80 years. ⑶Underwent cardiac surgery or had chronic kidney disease.'}, 'identificationModule': {'nctId': 'NCT04596332', 'briefTitle': 'Central Venous Pressure Monitoring and Prognosis of High-risk Operating Patients', 'organization': {'class': 'OTHER', 'fullName': 'Fujian Provincial Hospital'}, 'officialTitle': 'Central Venous Pressure Monitoring is Associated With Improved Prognosis of High-risk Operating Patients During Perioperative Period', 'orgStudyIdInfo': {'id': 'K2018-09-006'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': 'Patients with the initial central venous pressure(CVP1) \\<8 mm Hg', 'interventionNames': ['Other: no intervention measures']}, {'label': 'Group B', 'description': 'Patients with 8≤CVP1≤12mm Hg', 'interventionNames': ['Other: no intervention measures']}, {'label': 'Group C', 'description': 'Patients with CVP1\\>12 mm Hg', 'interventionNames': ['Other: no intervention measures']}], 'interventions': [{'name': 'no intervention measures', 'type': 'OTHER', 'description': 'Because this study was a retrospective study, no intervention measures were implemented for the patients enrolled.', 'armGroupLabels': ['Group A', 'Group B', 'Group C']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jiafang Wu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Critical Care Medicine, Fujian Provincial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Provincial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Critical Care Medicine, Fujian Provincial Hospital', 'investigatorFullName': 'Xiuling Shang', 'investigatorAffiliation': 'Fujian Provincial Hospital'}}}}