Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2026-02-28 @ 9:32 AM
Study NCT ID:
NCT06475261
Status:
RECRUITING
Last Update Posted:
2025-03-07
First Post:
2024-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tissue Oximetry's Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2024-06-20', 'studyFirstSubmitQcDate': '2024-06-20', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between intraoperative tissue oximetry and postoperative acute renal injury.', 'timeFrame': 'Tissue oximetry is defined as TWA (time-weighted average) value resulted by values recorded intraoperatively every 20 minutes.', 'description': 'An intraoperative mean tissue oximetry value of 65% or less is considered to predict cellular damage. Postoperative renal injury is classified according to AKIN and KIDGO criteria.'}], 'secondaryOutcomes': [{'measure': 'Tissue oximetry', 'timeFrame': 'TWA value resulted by intraoperative values recorded every 20 minutes during surgery.', 'description': 'Describing intraoperative variation of tissue oximetry expressed in percent.'}, {'measure': 'Tissue oximetry during hyperthermic intraperitoneal chemotherapy', 'timeFrame': 'TWA value resulted by intraoperative values recorded every 20 minutes during hyperthermic intraperitoneal chemotherapy .', 'description': 'Describing variation of tissue oximetry during hyperthermic intraperitoneal chemotherapy, expressed in percent.'}, {'measure': 'Emodinamic parameters (systolic, mean and diastolic pressures)', 'timeFrame': 'Intraoperatively, a mean value resulted by values recorded every 20 minutes during surgery.', 'description': 'Describing mean values of intraoperative arterial pressure (systolic, mean and diastolic pressures), expressed in mmHg'}, {'measure': 'Emodinamic parameters (systolic, mean and diastolic pressures) during hyperthermic intraperitoneal chemotherapy', 'timeFrame': 'A mean value resulted by values recorded every 20 minutes during hyperthermic intraperitoneal chemotherapy', 'description': 'Describing mean values of arterial pressure (systolic, mean and diastolic pressures), expressed in mmHg, during hyperthermic intraperitoneal chemotherapy'}, {'measure': 'Serum Creatinine level', 'timeFrame': 'From 1st to 7th postoperative days', 'description': 'Mean value of creatinine, daily assessed for the first 7 postoperative days, expressed in mg/dL'}, {'measure': 'Serum Blood urea nitrogen level', 'timeFrame': 'From 1st to 7th postoperative day', 'description': 'Mean value of Serum blood urea nitrogen, daily assessed for the first 7 postoperative days, expressed in mg/dL'}, {'measure': 'Serum sodium level', 'timeFrame': 'From 1st to 7th postoperative day', 'description': 'Mean values of Serum sodium, daily assessed for the first 7 postoperative days, expressed in mmol/L'}, {'measure': 'Serum Potassium level', 'timeFrame': 'From 1st to 7th postoperative day', 'description': 'Mean values of Serum potassium, daily assessed for the first 7 postoperative days, expressed in mmol/L'}, {'measure': 'Serum Chloride level', 'timeFrame': 'From 1st to 7th postoperative day', 'description': 'Mean values of Serum chloride, daily assessed for the first 7 postoperative days, expressed in mmol/L'}, {'measure': 'Serum Calcium level', 'timeFrame': 'From 1st to 7th postoperative day', 'description': 'Mean values of Serum calcium, daily assessed for the first 7 postoperative days, expressed in mmol/L'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tissue Oximetry', 'Hyperthermic Intraperitoneal Chemotherapy', 'Acute Kidney Injury', 'Hemodynamics parameters'], 'conditions': ['Oxygen Deficiency', 'Acute Kidney Injury', 'Ovarian Carcinoma']}, 'descriptionModule': {'briefSummary': "Tissue oximetry obtained from peripheral muscle measures the state of tissue oxygenation of various organs and, as already widely described in the literature, can be used to measure the state of kidney's tissue oxygenation. However, there is no evidence in the existing scientific literature on the use of muscle tissue oximetry in patients undergoing cytoreductive surgery for ovarian cancer with hyperthermic intraperitoneal chemotherapy.\n\nThe primary objective of our study is to evaluate whether there is a correlation between average intraoperative muscle tissue oximetry below 65% (a value which is considered critical in the literature for the resulting cellular damage) and postoperative renal damage in patients undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy for ovarian cancer.", 'detailedDescription': "Tissue oximetry obtained from peripheral muscle can be used to measure the state of kidney's tissue oxygenation.\n\n50 Adult female patients ASA 1-2 undergoing cytoreductive surgery with laparoscopic or laparotomy technique (for ovarian cancer) associated with hyperthermic intraperitoneal chemotherapy will be enrolled.\n\nThe primary objective of our study is to evaluate whether there is a correlation between average intraoperative muscle tissue oximetry below 65% (a value which is considered critical in the literature for the resulting cellular damage) and postoperative renal damage (according to the AKIN and KIDGO classification) in patients undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy for ovarian cancer.\n\nSecondary objectives are:\n\n* describe the variation in muscle tissue oximetry and hemodynamic parameters (systolic, mean, diastolic blood pressure) during cytoreductive surgery with hyperthermic intraperitoneal chemotherapy .\n* describe the variation in renal function values (blood urea nitrogen, creatinine) and serum electrolytes (sodium, potassium, chloremia, calcemia) in the post-operative period (from the first to the seventh postoperative day)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult female patients ASA 1-2 undergoing cytoreductive surgery with laparoscopic or laparotomy technique (for ovarian cancer) associated with hyperthermic intraperitoneal chemotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society Anesthesiologists (ASA) Classification 1-2\n* Cytoreductive surgery for ovarian cancer with laparoscopic or laparotomic technique with Hypertermic Intraperitoneal Chemotherapy.\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* ASA \\> or = 3\n* Cytoreductive surgery without hyperthermic intraperitoneal chemotherapy'}, 'identificationModule': {'nctId': 'NCT06475261', 'briefTitle': "Tissue Oximetry's Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy", 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': "Tissue Oximetry's Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy: Prospective Observational Study With Device", 'orgStudyIdInfo': {'id': '6702'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tissue Oximetry with ForeSight', 'type': 'DEVICE', 'otherNames': ['Hemodynamics parameters with Hemosphere'], 'description': 'Evaluation of a correlation between average intraoperative muscle tissue oximetry and postoperative renal damage in patients undergoing cytoreductive surgery with HIPEC for ovarian cancer'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Stefano Catarci, MD', 'role': 'CONTACT', 'email': 'stefano.catarci@policlinicogemelli.it', 'phone': '06 3015 3744'}, {'name': 'Stefano Catarci, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Policlinico "A. Gemelli" IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Stefano Catarci, MD', 'role': 'CONTACT', 'email': 'stefano.catarci@policlinicogemelli.it', 'phone': '0630153744'}], 'overallOfficials': [{'name': 'Stefano Catarci, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FPG IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}