Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-26 @ 5:05 PM
Study NCT ID:
NCT06685159
Status:
RECRUITING
Last Update Posted:
2025-04-01
First Post:
2024-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictors of Postoperative Complications in Surgery With Pneumoperitoneum in the Trendelenburg Position
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011027', 'term': 'Pneumoperitoneum'}], 'ancestors': [{'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010535', 'term': 'Laparoscopy'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and urine samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-06-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-30', 'studyFirstSubmitDate': '2024-11-06', 'studyFirstSubmitQcDate': '2024-11-11', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perioperative change in urine NGAL', 'timeFrame': 'Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery', 'description': 'Measurement of the concentration of neutrophil gelatinase-associated lipocalin (as an early marker of kidney injury) in a urine sample taken from a Foley catheter'}, {'measure': 'Acute Kidney Injury', 'timeFrame': '2 hours after completion of surgery; 1 day after the procedure; 3 days after the procedure.', 'description': 'According to the KDIGO acute renal injury stage'}, {'measure': 'Perioperative change in serum NGAL', 'timeFrame': 'Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery', 'description': 'Measurement of the concentration of neutrophil gelatinase-associated lipocalin (as an early marker of kidney injury) in a blood sample'}, {'measure': 'Perioperatitve change in serum concentration of Cannabidiol', 'timeFrame': 'Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery and 2h hours after completion of surgery', 'description': 'Measurement of the concentration of cannabidiol (as an early marker of kidney injury) in a blood sample'}, {'measure': 'Perioperatitve change in urine concentration of Cannabidiol', 'timeFrame': 'Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery', 'description': 'Measurement of the concentration of cannabidiol (as an early marker of kidney injury) in a urine sample taken from a Foley catheter'}, {'measure': 'Perioperatitve change in TBW', 'timeFrame': 'Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery', 'description': 'Perioperative change in the bioimpedence-based measurement of Total Body Water (TBW)'}, {'measure': 'Perioperatitve change in ECW', 'timeFrame': 'Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery', 'description': 'Perioperative change in the bioimpedence-based measurement of Extracellular Water (ECW)'}, {'measure': 'Perioperatitve change in serum pH', 'timeFrame': 'Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery', 'description': 'As measured by arterial blood gas'}, {'measure': 'Perioperatitve change in serum BE', 'timeFrame': 'Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery', 'description': 'Perioperatitve change in serum Base Excess (BE) As measured by arterial blood gas'}, {'measure': 'Perioperatitve change in serum lactate concentration', 'timeFrame': 'Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery', 'description': 'Perioperatitve change in serum lactate concentration as measured by arterial blood gas'}, {'measure': 'Perioperatitve change in serum syndecan-1 concentration', 'timeFrame': 'Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery', 'description': 'Measured by ELISA'}], 'secondaryOutcomes': [{'measure': 'Delirium', 'timeFrame': 'Within 7 days after surgery', 'description': 'As assessed by CAM-ICU'}, {'measure': 'CVA / TIA', 'timeFrame': 'Within 30 days after surgery', 'description': 'New diagnosis of cerebrovascular accident or transient ischemic attack'}, {'measure': 'Myocardial Ischemia', 'timeFrame': 'During hospital stay, within 30 days after surgery', 'description': 'New myocardial ischemia, as diagnosed by ecg or serum troponin'}, {'measure': 'Arrhythmia', 'timeFrame': 'During hospital stay, within 30 days after surgery', 'description': 'New clinically significant arrhythmia'}, {'measure': 'Atelectasis', 'timeFrame': 'During hospital stay, within 30 days after surgery', 'description': 'New atelectasis'}, {'measure': 'Pneumonia', 'timeFrame': 'During hospital stay, within 30 days after surgery', 'description': 'According to CDC criteria'}, {'measure': 'ARDS', 'timeFrame': 'During hospital stay, within 30 days after surgery', 'description': 'New Acute Respiratory Distress Syndrome (ARDS) according to Berlin criteria'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trendelenburg Position', 'Pneumoperitoneum']}, 'descriptionModule': {'briefSummary': 'Evaluate early postoperative complications after surgery in Trendelenburg position with increased intraabdominal pressure (surgery with pneumoperitoneum). Evaluate the relationship between hemodynamic and metabolic changes on perioperative outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients who undergo elective laparoscopic surgery in the Hadassah Ein-Kerem Medical Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA Class I-IV.\n* Planned for laparoscopic surgery in the Trendelenburg position that is expected to last more than 2 hours.\n* Planned arterial catheter insertion.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Planned open abdominal surgery.\n* Renal Replacement Therapy.'}, 'identificationModule': {'nctId': 'NCT06685159', 'briefTitle': 'Predictors of Postoperative Complications in Surgery With Pneumoperitoneum in the Trendelenburg Position', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Risk Factors for Postoperative Complications in Surgery With Pneumoperitoneum in Trendelenburg Position. Observational Pilot Study', 'orgStudyIdInfo': {'id': '0303-23 HMO'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Laparoscopic Surgery', 'type': 'PROCEDURE', 'description': 'Laparoscopic surgery (with controlled pneumoperitoneum) in the Trendelenburg position'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'state': 'Yerushalaim', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Adir Ben-Nahum, M.D.', 'role': 'CONTACT', 'email': 'adirbn@gmail.com', 'phone': '+972504677005'}], 'facility': 'Hadassah Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Reuven Pizov, MD', 'role': 'CONTACT', 'email': 'pizovr@hadassah.org.il', 'phone': '+9720506265542'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Reuven Pizov', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Anesthesia Department Chair', 'investigatorFullName': 'Reuven Pizov', 'investigatorAffiliation': 'Hadassah Medical Organization'}}}}