Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-26 @ 5:41 PM
Study NCT ID:
NCT05626868
Status:
UNKNOWN
Last Update Posted:
2022-11-25
First Post:
2022-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes of Intra Abdominal Pressure During Surgeries in Prone Position as a Marker of Renal Damage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059325', 'term': 'Intra-Abdominal Hypertension'}], 'ancestors': [{'id': 'D003161', 'term': 'Compartment Syndromes'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-15', 'studyFirstSubmitDate': '2022-11-15', 'studyFirstSubmitQcDate': '2022-11-15', 'lastUpdatePostDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase in intra abdominal pressure during surgery.', 'timeFrame': 'Intraoperative', 'description': 'Change in intra abdominal pressure during surgery in prone position.'}], 'secondaryOutcomes': [{'measure': 'Correlation of increased abdominal pressure with renal dysfunction assessed by creatinine.', 'timeFrame': 'From start to eight hours after the surgery.', 'description': 'Assessment of renal function in labolatory tests: creatinine change (mg/dl).'}, {'measure': 'Correlation of increased abdominal pressure with renal dysfunction assessed by urea.', 'timeFrame': 'From start of surgery to eight hours after the surgery.', 'description': 'Assessment of renal function in labolatory tests: urea change (mg/dl).'}, {'measure': 'Correlation of increased abdominal pressure with renal dysfunction assessed by potassium.', 'timeFrame': 'From start of surgery to eight hours after the surgery.', 'description': 'Assessment of renal function in labolatory tests: potassium change (mg/dl).'}, {'measure': 'Correlation of increased abdominal pressure with mioglobin.', 'timeFrame': 'From start of surgery to eight hours after the surgery.', 'description': 'Assessment in labolatory tests: mioglobin change (mg/dl).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intraabdominal Hypertension', 'Prone Postion', 'Spine Surgery']}, 'descriptionModule': {'briefSummary': 'Background: Patients undergoing surgical operations in prone position do not have a measure of intra abdominal pressure as a standard procedure. Many of them could have elevated values of this parameter and could be exposed to possible renal damage due to a stiffening of the abdominal muscles while being positioned prone.\n\nPurpose of study: Intraoperative intrabdominal pressure measurement and evaluation of correlation with possible postsurgical complications.\n\nMethodology: Electronic device able to measure intra abdominal pressure is connected between a Foley catheter and a urinary collecting bag. During the procedure, values of the intra abdominal pressure are displayed on a monitor next to anaesthetic machine in real time. The numbers representing the pressure in mmHG are assessed and recorded.\n\nDiscussion: Possible correlation between intra abdominal hypertension and postsurgical complications in patients operated in prone position could be a foundation to further clinical trials and presurgical assessment of intraabdominal pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients qualified for spinal surgery in prone position, who consent to praticipate in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consent to participate in the study\n* Patients qualified for surgical stabilization of the spine in prone position\n\nExclusion Criteria:\n\n* No consent to participate in the study or inability to obtain consent\n* The inability to insert a urinary catheter\n* No indication for urinary catheter\n* Patients undergoing palliative treatment\n* Patients with advanced liver and kidney disease'}, 'identificationModule': {'nctId': 'NCT05626868', 'briefTitle': 'Changes of Intra Abdominal Pressure During Surgeries in Prone Position as a Marker of Renal Damage', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'Intraoperative Abdominal Pressure Measurement in Patients Undergoing Spine Surgeries in Prone Position as a Marker of Renal Damage', 'orgStudyIdInfo': {'id': 'MG/M/37/37/20(1)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients for spine surgery in prone position', 'interventionNames': ['Device: Intra abdominal pressure measurement']}], 'interventions': [{'name': 'Intra abdominal pressure measurement', 'type': 'DEVICE', 'description': 'Device: Biometrix - Intraabdominal pressure monitoring set Intraabdominal pressure monitoring with the intended set in values of milimeters of mercury (mmHg) in real time.', 'armGroupLabels': ['Patients for spine surgery in prone position']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-005', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Rafał Kowałczyk, MD', 'role': 'CONTACT', 'email': 'rafal.kowalczyk@wum.edu.pl', 'phone': '+48 22 5021685'}], 'facility': 'Medical University of Warsaw: 1st Department of Anaesthesiology and Intensive Therapy', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Bartosz Stangiewicz, MD', 'role': 'CONTACT', 'email': 'bartosz.stangiewicz@wum.edu.pl', 'phone': '+48605941973'}], 'overallOfficials': [{'name': 'Rafał Kowalczyk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Unieveristy of Warsaw'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}