Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-31 @ 3:14 AM
Study NCT ID:
NCT03594695
Status:
COMPLETED
Last Update Posted:
2018-10-15
First Post:
2018-01-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hs-CRP and NLR as Markers of Perioperative Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-12', 'studyFirstSubmitDate': '2018-01-15', 'studyFirstSubmitQcDate': '2018-07-19', 'lastUpdatePostDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the change in HSCRP levels', 'timeFrame': 'preoperative, postoperative 2nd and 4th hours, fetal cord blood sample (following delivery)', 'description': 'Measurement of high sensitive C reactive protein levels in different time points in order to evaluate the change in HSCRP levels'}, {'measure': 'Evaluation of the change in NLR', 'timeFrame': 'preoperative, postoperative 2nd and 4th hours, fetal cord blood sample (following delivery)', 'description': 'Measurement of the Neutrophil to Lymphocyte Ratio in different time points in order to evaluate the change in the Neutrophil to Lymphocyte Ratios'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cesarean section, anesthesia, hs-CRP, NLR'], 'conditions': ['Cesarean Delivery Affecting Newborn', 'Anesthesia', 'Inflammatory Response']}, 'referencesModule': {'references': [{'pmid': '27583931', 'type': 'BACKGROUND', 'citation': 'Chen Y, Jiang S, Wu Y. Effect of 2 different anesthesia methods on stress response in neurosurgical patients with hypertension or normal: A prospective clinical trial. Medicine (Baltimore). 2016 Aug;95(35):e4769. doi: 10.1097/MD.0000000000004769.'}, {'pmid': '24265885', 'type': 'BACKGROUND', 'citation': 'Farzadnia M, Ayatollahi H, Hasan-Zade M, Rahimi HR. A comparative study of vascular cell adhesion molecule-1 and high-sensitive C-reactive protein in normal and preeclamptic pregnancies. Interv Med Appl Sci. 2013 Mar;5(1):26-30. doi: 10.1556/IMAS.5.2013.1.5. Epub 2013 Mar 19.'}]}, 'descriptionModule': {'briefSummary': 'The stress response to surgery is a result of tissue injury with local and systemic inflammation that contributes to the postoperative outcome. Anesthesia is known to effect perioperative stress response Regional anesthesia modifies stress response through afferent blockage whereas general anesthesia affects the stress response via central modulation. High sensitive C-reactive protein and neutrophil to lymphocyte ratio are used for evaluation of inflammation. The aim of this study was to document the value hs-CRP and NLR in perioperative stress response in two different anesthesia methods applied to term pregnant women undergoing elective ceserean section (C/S).', 'detailedDescription': 'The stress response to surgery is a result of tissue injury with local and systemic inflammation that contributes to the postoperative outcome. Anesthesia is known to effect perioperative stress response. Regional anesthesia modifies stress response through afferent blockage whereas general anesthesia affects the stress response via central modulation. High sensitive C-reactive protein and neutrophil to lymphocyte ratio are used for evaluation of inflammation. The degree of systemic inflammation has been determined by numerous pro- and anti-inflammatory cytokines.The cytokines control the release of C -reactive protein (CRP) which is an acute phase reactant produced by the liver. CRP is a widely used marker of inflammation and tissue damage. High sensitive C -reactive protein (hs-CRP), is a more sensitive assay for detection of inflammation measured by particle-enhanced immunonephelometry . A rapid increase in hs-CRP may indicate inflammation and tissue damage . Another well-known indicator of inflammation is neutrophil-to-lymphocyte ratio (NLR). NLR correlates strongly with elevated plasma levels of circulating proinflammatory cytokineS. The aim of this study was to document the value hs-CRP and NLR in perioperative stress response in two different anesthesia methods applied to term pregnant women undergoing elective ceserean section (C/S).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is composed of healthy pregnant women without chronic diseases at term (36-41 weeks of pregnancy).', 'genderDescription': 'This observational study is conducted in cesarean sections', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy pregnant women without chronic diseases at term (36-41 weeks of pregnancy)\n\nExclusion Criteria:\n\n* refusal to participate,\n* chronic diseases (diabetes mellitus, hypertension, heart disease, renal disease, hypo/hyperthyroidism)\n* any infections,\n* smoking\n* contraindications for central neuraxial anesthesia.\n* Pregnancies complicated with rupture of membranes, placenta previa, eclampsia/preeclampsia, and abruptio placenta\n* fetal anomalies,\n* abnormality detected at fetal well-being tests'}, 'identificationModule': {'nctId': 'NCT03594695', 'briefTitle': 'Hs-CRP and NLR as Markers of Perioperative Stress', 'organization': {'class': 'OTHER', 'fullName': 'Ufuk University'}, 'officialTitle': 'Hs-CRP and NLR as Markers of Perioperative Stress in Maternal And Fetal Blood in Different Anesthesia Techniques', 'orgStudyIdInfo': {'id': 'hsCRP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group G', 'description': 'Patients undergoing general anesthesia HSCRP and NLR measurement', 'interventionNames': ['Diagnostic Test: HSCRP and NLR']}, {'label': 'Group R', 'description': 'Patients undergoing spinal anesthesia HSCRP and NLR measurement', 'interventionNames': ['Diagnostic Test: HSCRP and NLR']}], 'interventions': [{'name': 'HSCRP and NLR', 'type': 'DIAGNOSTIC_TEST', 'description': 'hs-CRP levels and NLR values will be studied from routine blood samples.', 'armGroupLabels': ['Group G', 'Group R']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06520', 'city': 'Ankara', 'state': 'Balgat', 'country': 'Turkey (Türkiye)', 'facility': 'Ufuk University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Hakan Yılmaz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ufuk University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ufuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc Prof', 'investigatorFullName': 'Hakan Yılmaz', 'investigatorAffiliation': 'Ufuk University'}}}}