Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT03853005
Status:
COMPLETED
Last Update Posted:
2024-08-19
First Post:
2018-07-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of High volumeHemodiafiltration on Lung Oxygenation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-14', 'studyFirstSubmitDate': '2018-07-10', 'studyFirstSubmitQcDate': '2019-02-22', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Interleukin-6', 'timeFrame': '0 hour, 24 hours, and 48 hours after start of HVHDF', 'description': 'Changes in Interleukin-6 (ng/dL)'}], 'primaryOutcomes': [{'measure': 'Arterial oxygen pressure (PaO2)', 'timeFrame': '24 hours after start of HVHDF', 'description': 'Change in arterial oxygen pressure (PaO2) in units of millimeter mercury (mmHg)'}], 'secondaryOutcomes': [{'measure': 'The ratio of arterial oxygen pressure to the fraction of inspired oxygen (PaO2/ FiO2 ratio)', 'timeFrame': '0 hour, 24 hours, and 48 hours after start of HVHDF', 'description': 'Changes in the ratio of arterial oxygen pressure to the fraction of inspired oxygen (PaO2/ FiO2 ratio)'}, {'measure': 'Ventilatory function', 'timeFrame': '0 hour, 24 hours, and 48 hours after start of HVHDF', 'description': 'Changes in compliance (ml/cmH2O)'}, {'measure': 'The duration for weaning from mechanical ventilation (MV)', 'timeFrame': '28 days', 'description': 'Days until weaning the patient from mechanical ventilation (MV)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Haemofiltration', 'Lung Mechanics', 'Septic Patients']}, 'descriptionModule': {'briefSummary': 'High volume hemodiafiltration (HVHDF) has been used in septic patients to get hemodynamic improvement and possibly survival benefit.', 'detailedDescription': 'Sepsis, defined as life-threatening organ dysfunction caused by dysregulated immune response to infection. Hemofiltration has been suggested as beneficial in restoring immune homeostasis. High volume hemodiafiltration (HVHDF) is a hybrid method of intermittent renal replacement therapy (RRT), where high filtration volumes are applied. In several studies; higher filtration volumes have been shown to achieve hemodynamic improvement and possibly survival benefit in patients with septic shock.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. ≥ 18 years\n2. Severe sepsis defined by Quick SOFA score by presentation of 2 or more of the following criteria:\n\n * Mental clouding: decreased glasco coma scale GCS \\< 15\n * Hypotension: Systolic blood pressure \\< 100 mmgH\n * Tachypnea: respiratory rate \\> 22 breath/ minute Then serum lactate is analysed to confirm sepsis hypoperfusion if ≥ 2mmol/L\n3. Organs dysfunction (including one of them respiratory failure).\n\nOrgan dysfunctions are defined as following:\n\nRespiratory dysfunction (criteria for ARDS):\n\n* PaO2/FiO2 \\<200\n* Bilateral infiltrates in chest X-ray\n* Resistant hypoxemia\n* Tachypnoea (RR \\> 40 breath/minute)\n* The need for invasive mechanical ventilation\n* Excluded cardiac causes of pulmonary edema\n\nCNS failure:\n\n* Decreased GCS ≥ 4 decreased points\n\nCVS dysfunction:\n\n* Sustained hypotension even on very high inotropes doses (Noradrenaline \\>1µm/min)+ adrenaline\\>1.5µm/min associated\n* with high CVP pressure \\> 12 mmHg and not responding to fluid challenge test to exclude hypovolemia.\n* Cardiomegaly detected by either echocardiography assessment, or chest X-ray\n* Resistant frequent ventricular ectopics not explained by organic causes.\n\nLiver dysfunction:\n\n* Elevated total and direct bilirubin than double normal or basal levels\n* Elevated prothrombin time \\> 17 seconds or INR \\> 1.5\n* Elevated liver enzymes \\> triple normal level\n\nRenal dysfunction:\n\n* Decreased urine output \\< 0.5 ml/kg.\n* Elevated creatinine level \\> 164 µmol/L (1.5mg/dL).\n* Decreased creatinine clearance \\<50ml/minute if available.\n\nBone marrow depression:\n\n* Decreased platelets \\< 90 X 103/µL\n* Decreased leukocytes \\<4 X 103/µL\n* Decreased RBCs count \\< 4 X 106/µL\n\nExclusion Criteria:\n\n1. Patient relatives' refusal\n2. Pregnancy\n3. Recent active internal hemorrhage\n4. Not mechanically ventilated.\n5. Hypersensitivity to the dialyser fluid"}, 'identificationModule': {'nctId': 'NCT03853005', 'briefTitle': 'Effect of High volumeHemodiafiltration on Lung Oxygenation', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of High Volume Hemodiafiltration on Lung Oxygenation, Lung Mechanics and Biomarkers in Mechanically Ventilated Patients With Severe Sepsis', 'orgStudyIdInfo': {'id': '28503011700371A1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group A (controlled group)', 'description': 'They will not receive HVHDF treatment', 'interventionNames': ['Other: controlled']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (HVHDF group)', 'description': 'They will receive HVHDF treatment for 48 hours. HVHDF will be performed via indwelling central venous catheter. The blood flow will be 180-240 ml/min, and ultrafiltration rate will be 70 ml/kg/h during HVHF. The substitute fluid will be infused with pre-dilution. Heparin will be used for anti-coagulation, whose initial dose will be 15-25 U/kg, and maintenance dose is 5-15 U/kg/h. aPTT time maintained between 60-80 second and will be checked every 12 hours. The survival status of all of the subjects were followed up at 28 days after being diagnosed as severe sepsis.', 'interventionNames': ['Other: HVHDF']}], 'interventions': [{'name': 'HVHDF', 'type': 'OTHER', 'description': 'Patients will receive HVHDF treatment for 48 hours. HVHDF will be performed via indwelling central venous catheter. The blood flow will be 180-240 ml/min, and ultrafiltration rate will be 70 ml/kg/h during HVHF. The substitute fluid will be infused with pre-dilution. Heparin will be used for anti-coagulation, whose initial dose will be 15-25 U/kg, and maintenance dose is 5-15 U/kg/h. aPTT time maintained between 60-80 second and will be checked every 12 hours.', 'armGroupLabels': ['Group B (HVHDF group)']}, {'name': 'controlled', 'type': 'OTHER', 'description': 'Patients will receive the usual care', 'armGroupLabels': ['Group A (controlled group)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Faculty of medicine - Assiut university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Assiut university A Egypt', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ayman Abd ELkhalek Mohammed, lecturer, clinical anesthesiologist and principal investigator', 'investigatorFullName': 'Ayman Abd El-Khalek Mohammed Glala', 'investigatorAffiliation': 'Assiut University'}}}}