Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
Study NCT ID:
NCT02083757
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2014-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fluid Responsiveness Predicted by PtcO2 in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-10-06', 'releaseDate': '2017-05-12'}, {'resetDate': '2022-07-12', 'releaseDate': '2022-03-15'}], 'estimatedResultsFirstSubmitDate': '2017-05-12'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012769', 'term': 'Shock'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-26', 'studyFirstSubmitDate': '2014-03-07', 'studyFirstSubmitQcDate': '2014-03-07', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac Output', 'timeFrame': '30min', 'description': 'Noninvasive bioreactance CO monitoring was obtained using the NICOM system (Cheetah Medical, Portland, OR) with four double-electrode stickers placed on the chest wall.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fluid responsiveness; Passive leg raising'], 'conditions': ['Circulatory Failure']}, 'referencesModule': {'references': [{'pmid': '28536944', 'type': 'DERIVED', 'citation': 'Xu J, Peng X, Pan C, Cai S, Zhang X, Xue M, Yang Y, Qiu H. Fluid responsiveness predicted by transcutaneous partial pressure of oxygen in patients with circulatory failure: a prospective study. Ann Intensive Care. 2017 Dec;7(1):56. doi: 10.1186/s13613-017-0279-0. Epub 2017 May 23.'}]}, 'descriptionModule': {'briefSummary': 'Our goal was to study the feasibility of predicting fluid responsiveness by transcutaneous partial pressure of oxygen (PtcO2) in the critically ill patients.', 'detailedDescription': 'The clinical determination of the intravascular volume can be extremely difficult in critically ill patients. Although hemodynamic maximization was proposed, this approach was associated with a risk of fluid overload and excessive inotropic support. Therefore, fluid optimization was seen as a significant step forward and has been shown to decrease complications. Significant effort has been devoted to defining and developing simple means for predicting fluid responsiveness, i.e. whether the patient will benefit from fluid administration. Passive leg raising (PLR), a bedside performed test, could be used to accurately predict fluid responsiveness in most conditions.\n\nHowever, most parameters that provide information about fluid responsiveness during volume expansion and PLR are invasive and time-consuming. A completely noninvasive and atraumatic parameter to predict fluid responsiveness might be need urgently. Transcutaneous partial pressure of oxygen (PtcO2), a measure to detect tissue ischemia or inadequate perfusion, might reflect the change in cardiac output, thus predict fluid responsiveness. The purpose of this study was to study the feasibility of predicting fluid responsiveness by transcutaneous partial pressure of oxygen in the critically ill patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients for whom the attending physician decided to perform a fluid challenge or presence of at least one clinical sign of inadequate tissue perfusion in the absence of contraindication for fluid infusion for less than 24 hours were eligible to participate in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical signs of inadequate tissue perfusion defined as systolic blood pressure \\< 90 mm Hg or a decrease \\> 40 mmHg in previously hypertensive patients or the need for vasopressive drugs (dopamine \\> 5 ug/kg/min or norepinephrine); urine output \\< 0.5 ml/kg/hr for 2 hrs; tachycardia; presence of skin mottling.\n\nExclusion Criteria:\n\n* pregnancy, age of less than 18 years, contraindication to passive leg raising test, cardiac arrhythmias, cardiogenic pulmonary edema, the presence of abdominal compartment syndrome and refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT02083757', 'acronym': 'PtcO2-FR', 'briefTitle': 'Fluid Responsiveness Predicted by PtcO2 in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Southeast University, China'}, 'officialTitle': 'Fluid Responsiveness Predicted by Transcutaneous Partial Pressure of Oxygen in Critically Ill Patients', 'orgStudyIdInfo': {'id': '2011ZDllKY03.0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Resp', 'description': 'Fluid responsiveness is defined as a change of stroke volume stroke volume ≥ 10% after 250 ml rapid saline infusion in 10 minutes.'}, {'label': 'Nonresp', 'description': 'Fluid responsiveness is defined as a change of stroke volume stroke volume \\< 10% after 250 ml rapid saline infusion in 10 minutes.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Zhongda Hospital Southeast University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southeast University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Zhongda Hospital', 'investigatorFullName': 'Jingyuan,Xu', 'investigatorAffiliation': 'Southeast University, China'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-05-12', 'type': 'RELEASE'}, {'date': '2017-10-06', 'type': 'RESET'}, {'date': '2022-03-15', 'type': 'RELEASE'}, {'date': '2022-07-12', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Jingyuan,Xu, Zhongda Hospital, Southeast University, China'}}}}