Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT05612802
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2022-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A New Marker for Early Diagnosis of Pneumoperitoneum-Related Acute Kidney Injury: Insulin-Like Growth Factor-1 (IGF-1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D011027', 'term': 'Pneumoperitoneum'}], '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'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-03', 'studyFirstSubmitDate': '2022-09-06', 'studyFirstSubmitQcDate': '2022-11-08', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of acute kidney injury in the early postoperative period with IGF-1 (insulin like growth factor-1)', 'timeFrame': 'before pneumoperitoneum, after pneumoperitoneum, and at the postoperative 24th hour.', 'description': 'The researchers investigate whether IGF-1 will be an effective indicator in acute kidney injury by comparing IGF-1 and NGAL (Neutrophil gelatinase-associated lipocalin) values before pneumoperitoneum, after pneumoperitoneum and at the postoperative 24th hour.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury (Nontraumatic)', 'Pneumoperitoneum']}, 'referencesModule': {'references': [{'pmid': '31687986', 'type': 'BACKGROUND', 'citation': 'Gumbert SD, Kork F, Jackson ML, Vanga N, Ghebremichael SJ, Wang CY, Eltzschig HK. Perioperative Acute Kidney Injury. Anesthesiology. 2020 Jan;132(1):180-204. doi: 10.1097/ALN.0000000000002968.'}, {'pmid': '33606739', 'type': 'BACKGROUND', 'citation': 'Marton Filho MA, Alves RL, Nascimento PD Junior, Tarquinio GDS, Mega PF, Pinheiro Modolo NS. Effects of pneumoperitoneum on kidney injury biomarkers: A randomized clinical trial. PLoS One. 2021 Feb 19;16(2):e0247088. doi: 10.1371/journal.pone.0247088. eCollection 2021.'}, {'pmid': '26098754', 'type': 'BACKGROUND', 'citation': 'Sun B, Fu A, Wang R, Zhang Y. Influence of carbon dioxide pneumoperitoneum on the growth hormone-insulin-like growth factor I axis in mid- and late-pregnancy rats. J Obstet Gynaecol Res. 2015 Sep;41(9):1394-8. doi: 10.1111/jog.12734. Epub 2015 Jun 22.'}, {'pmid': '30348111', 'type': 'BACKGROUND', 'citation': 'Srisawat N, Kongwibulwut M, Laoveeravat P, Lumplertgul N, Chatkaew P, Saeyub P, Latthaprecha K, Peerapornratana S, Tiranathanagul K, Eiam-Ong S, Tungsanga K. The role of intraoperative parameters on predicting laparoscopic abdominal surgery associated acute kidney injury. BMC Nephrol. 2018 Oct 22;19(1):289. doi: 10.1186/s12882-018-1081-4.'}]}, 'descriptionModule': {'briefSummary': 'In our study, to show the effect of pneumoperitoneum on acute kidney injury in patients scheduled for laparoscopic surgery, NGAL and IGF-1 values will be measured before, after and 24 hours after pneumoperitoneum, and these values will be compared. In our study, we aimed to investigate the effect of pneumoperitoneum applied on acute kidney injury in patients who underwent laparoscopic surgery. Creatinine and NGAL have been used successfully in the follow-up of acute kidney injury. Our study investigates whether IGF-1 will be an effective indicator in acute kidney injury by comparing IGF-1 and NGAL values before pneumoperitoneum, after pneumoperitoneum and at the postoperative 24th hour.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18-70 years of both sexes\n* ASA I-III Patients\n\nExclusion Criteria:\n\n* Obesity,\n* Chronic Kidney Disease,\n* Chronic Renal Failure,\n* Acute Renal Failure,\n* Peripheral and ischemic vascular disease,\n* Chronic Heart Failure,\n* History of anaphylaxis,\n* A-V block,\n* Creatinine level \\>1.4,\n* Neuromuscular disease,\n* Malignant hypertension,\n* Pyelonephritis,\n* Urinary tract infectio,\n* Severe inflammation/possible sepsis,\n* Active malignancy,\n* Patients with surgery reversion to laparotomy,\n* Hemodynamic instability, need for vasopressors,\n* Severe bleeding requiring blood transfusion,'}, 'identificationModule': {'nctId': 'NCT05612802', 'briefTitle': 'A New Marker for Early Diagnosis of Pneumoperitoneum-Related Acute Kidney Injury: Insulin-Like Growth Factor-1 (IGF-1)', 'organization': {'class': 'OTHER', 'fullName': 'Baskent University'}, 'officialTitle': 'A New Marker for Early Diagnosis of Pneumoperitoneum-Related Acute Kidney Injury: Insulin-Like Growth Factor-1 (IGF-1)', 'orgStudyIdInfo': {'id': 'KA22/178'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'IGF', 'description': 'Creatinine and NGAL have been used successfully in the follow-up of acute kidney injury. In our study, in order to show the effect of pneumoperitoneum on acute kidney injury in patients scheduled for laparoscopic surgery, NGAL and IGF-1 values will be measured before, after and 24 hours after pneumoperitoneum, and these values will be compared.', 'interventionNames': ['Diagnostic Test: IGF-1']}], 'interventions': [{'name': 'IGF-1', 'type': 'DIAGNOSTIC_TEST', 'description': 'We need to diagnose acute kidney injury in the early postoperative period. The markers examined so far do not provide enough information to diagnose acute kidney injury early. For this reason, many different biomarkers are used in the early diagnosis of acute kidney injury in many parts of the world. Thanks to our research, we can recognise the development of acute kidney injury at an early stage and determine whether a previously unused biomarker (IGF-1) is effective in the early diagnosis of acute kidney injury.', 'armGroupLabels': ['IGF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06560', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Çağla Yazar, MD', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'NEDİM ÇEKMEN, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Baskent University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baskent University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Çağla Yazar, MD', 'investigatorAffiliation': 'Baskent University'}}}}