Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 2:33 PM
Study NCT ID:
NCT05637606
Status:
COMPLETED
Last Update Posted:
2025-06-11
First Post:
2022-11-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HIgh Versus STAndard Blood Pressure Target in Hypertensive High-risk Patients Undergoing Major Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004809', 'term': 'Ephedrine'}, {'id': 'D009638', 'term': 'Norepinephrine'}], 'ancestors': [{'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The trial intervention is not blinded for investigators, clinical staff, and patients, as blinding intraoperative MAP target is not feasible. The physicians of each center assessing all postoperative outcomes will be masked for the allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study will be a multicentric, randomized, non-blinded clinical trial. Eligible patients will be assigned in a 1:1 ratio to either a to control or treatment group. Randomization list will be created by a computer with the use of a permuted block design and embedded in the Electronic Case Report Form. Randomization will be performed using a \'block of 6" and stratified according to predefined baseline characteristics:\n\n1. Age ≥ 75 years\n2. Preoperative systolic pressure\n\n 1. \\< 140 mmHg\n 2. ≥ 140 mmHg'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 636}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-08', 'studyFirstSubmitDate': '2022-11-24', 'studyFirstSubmitQcDate': '2022-11-24', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'CARDIOVASCULAR complications', 'timeFrame': 'day 7 after operation', 'description': '* Acute heart failure\n* Myocardial injury after non-cardiac surgery\n* Myocardial infarction\n* Bradycardia\n* Symptomatic proximal deep venous thrombosis\n* Peripheral arterial and venous thrombosis'}, {'measure': 'NEUROLOGICAL complications', 'timeFrame': 'day 7 after operation', 'description': '* Stroke\n* Subarachnoid hemorrhage\n* Cerebral venous thrombosis\n* Seizure\n* Acute delirium'}, {'measure': 'RESPIRATORY', 'timeFrame': 'day 7 after operation', 'description': '* Acute respiratory distress\n* Hypoxemia with or without acute respiratory distress\n* Need for invasive, non-invasive ventilation or high-flow nasal cannula for acute respiratory distress.\n* Acute respiratory distress syndrome.\n* Pulmonary edema\n* Pulmonary embolism'}, {'measure': 'RENAL', 'timeFrame': 'day 7 after operation', 'description': '• Acute Kidney Injury (AKI) and AKI stages defined according to the AKIN classification/staging system of acute kidney injury'}, {'measure': 'SEPSIS and Septic shock', 'timeFrame': 'day 7 after operation', 'description': 'Based on the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) criteria, sepsis required a quick Sequential Organ Failure Assessment (qSOFA) Score ≥ 2 points due to infection, septic shock defined as indicated by the Surviving Sepsis Campaign Guidelines'}], 'primaryOutcomes': [{'measure': 'Composite endpoint of postoperative mortality and at least one major organ dysfunction (see description in the secondary outcomes).', 'timeFrame': 'up to 30 days after operation', 'description': 'Composite postoperative outcome'}], 'secondaryOutcomes': [{'measure': 'Hospital stay (days)', 'timeFrame': 'up to 30 days after operation', 'description': 'Hospital stay (days)'}, {'measure': 'ICU stay (days)', 'timeFrame': 'up to 30 days after operation', 'description': 'Intensive Care Unit stay (days)'}, {'measure': 'ICU readmission', 'timeFrame': 'up to 30 days after operation', 'description': 'Intensive Care Unit readmissions'}, {'measure': 'Sequential Organ Failure Assessment (SOFA) scores on postoperative', 'timeFrame': 'up to 7 days after operation', 'description': 'Postoperative organ failure - SOFA scores ranges from 0 (\\<2% of mortality) to 24 (\\>90% of mortality)'}, {'measure': 'Overall intraoperative fluid balance', 'timeFrame': 'day 1 after the operation', 'description': 'Intraoperative infusions (crystalloids, colloids, blood products) / Intraoperative loss balance (urine output)'}, {'measure': 'Mortality', 'timeFrame': 'up to 30 days after operation', 'description': 'Mortality'}, {'measure': 'Vasopressors use', 'timeFrame': 'day 1 after the operation', 'description': 'Dose and timing of vasoactive drug infusion intraoperatively'}, {'measure': 'Need for reoperation', 'timeFrame': 'day 30 after operation', 'description': 'Need of a new surgical treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood pressure', 'Intraoperative Hypotension', 'Postoperative complications', 'Postoperative mortality'], 'conditions': ['Blood Pressure', 'Complication,Postoperative', 'Intraoperative Hypotension']}, 'referencesModule': {'references': [{'pmid': '33522953', 'type': 'BACKGROUND', 'citation': 'Messina A, Robba C, Calabro L, Zambelli D, Iannuzzi F, Molinari E, Scarano S, Battaglini D, Baggiani M, De Mattei G, Saderi L, Sotgiu G, Pelosi P, Cecconi M. Association between perioperative fluid administration and postoperative outcomes: a 20-year systematic review and a meta-analysis of randomized goal-directed trials in major visceral/noncardiac surgery. Crit Care. 2021 Feb 1;25(1):43. doi: 10.1186/s13054-021-03464-1.'}, {'pmid': '23835589', 'type': 'BACKGROUND', 'citation': 'Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.'}]}, 'descriptionModule': {'briefSummary': 'This study is a multicenter randomized controlled trial comparing two strategies of mean arterial blood pressure management (MAP ≥ 80mmHg vs MAP ≥ 65 mmHg) in high-risk surgical patients undergoing elective laparotomic/laparoscopic surgery.', 'detailedDescription': 'Intraoperative hypotension has been associated with major postoperative complications after non-cardiac surgery. However, is is still unclear the optimal intraoperative mean arterial pressure (MAP) target in the subgroup of those patient with an history of hypertension at home, and at risk of developing postoperative complications.\n\nThe objective of this study is to assess the effects of an intraoperative blood pressure management strategy aiming at keeping the MAP ≥ 80mmHg), as compared to the conventional practice (to maintain intraoperative MAP ≥ 65mmHg), on a composite outcome considering the death rate and the incidence of major events in patient scheduled for elective laparotomic/laparoscopic surgery.\n\nThe primary outcome is a composite of 30-days from operation mortality rate and at least one major organ dysfunction including the renal, respiratory, cardiovascular and neurologic systems or new onset of sepsis and septic shock occurring by day 7 after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria (all the following)\n\n1. Adult patients ≥ 60 years\n2. History of chronic hypertension requiring home therapy.\n3. Scheduled for major elective abdominal surgery (laparoscopic, robotic or laparotomic)\n4. Expected surgical duration of at least 3 hours.\n5. Needing invasive arterial and hemodynamic monitoring as decided by the attending anesthetist, according to the rules of good clinical practice of each involved center.\n\nAND\n\nAt increased risk of postoperative complications (at least one of the following):\n\n1. American Society of Anesthesiologists (ASA) class 3 or 4\n2. Known or documented history of coronary artery disease (angina, myocardial infarction or acute coronary syndrome).\n3. Known or documented history of peripheral vascular disease.\n4. Known or documented history of heart failure requiring treatment.\n5. Ejection fraction less than 30% (echocardiography)\n6. Signs of diastolic moderate to severe dysfunction or chronic hypertensive cardiomyopathy (echocardiography)\n7. Moderate or severe valvular heart disease (echocardiography)\n8. Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) Radiographically confirmed or according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.\n9. Diabetes currently treated with an oral hypoglycemic agent and/or insulin\n10. Morbid obesity (BMI ≥35 kg/m2)\n11. Preoperative serum albumin \\<30 g/l\n12. Anaerobic threshold (if done) \\<14 ml/kg/min\n13. Exercise tolerance equivalent to six metabolic equivalents (METs) or less as defined by American College of Cardiology/American Heart Association guidelines\n\nExclusion criteria\n\n1. Refusal of consent\n2. Chronic kidney disease with glomerular filtration rate \\<30 ml/min/1.73 m2 or requiring renal-replacement therapy for end-stage renal disease\n3. Acute cardiovascular event, including acute or decompensated heart failure and acute coronary syndrome (within prior 30 days).\n4. Urgent or time-critical surgery\n5. Aortic or Renal vascular surgery (including nephrectomy)\n6. Liver Surgery\n7. Neurosurgery\n8. Surgery for palliative treatment only or ASA physical status 5\n9. Pregnancy'}, 'identificationModule': {'nctId': 'NCT05637606', 'acronym': 'HISTAP', 'briefTitle': 'HIgh Versus STAndard Blood Pressure Target in Hypertensive High-risk Patients Undergoing Major Abdominal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Humanitas Clinical and Research Center'}, 'officialTitle': 'HIgh Versus STAndard Blood Pressure Target in Hypertensive High-risk Patients: The HISTAP Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'HISTAP TRIAL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MAP 80', 'description': 'Intervention group: intraoperative mean blood pressure target \\> 80 mmHg. Treatment of hypotension (defined as a mean blood pressure of below 80 mmHg) using intravenous bolus or continuous infusion of vasopressors, or fluids using a dedicated algorithm considering the pulse pressure or stroke volume variation and the mini fluid challenge to optimize mean blood pressure values.', 'interventionNames': ['Drug: Ephedrine', 'Drug: Norepinephrine', 'Drug: Etilefrine Hydrochloride bolus', 'Diagnostic Test: Use of pulse pressure and stroke volume variation (PPV and SVV); use of Mini Fluid Challenge (mini_FC)']}, {'type': 'OTHER', 'label': 'MAP 65', 'description': 'Control group: intraoperative mean blood pressure target \\> 65 mmHg. Treatment of hypotension (defined as a mean blood pressure of below 65 mmHg) using intravenous bolus or continuous infusion of vasopressors, or fluids using a dedicated algorithm considering the pulse pressure or stroke volume variation and the mini fluid challenge to optimize mean blood pressure values.', 'interventionNames': ['Drug: Ephedrine', 'Drug: Norepinephrine', 'Drug: Etilefrine Hydrochloride bolus', 'Diagnostic Test: Use of pulse pressure and stroke volume variation (PPV and SVV); use of Mini Fluid Challenge (mini_FC)']}], 'interventions': [{'name': 'Ephedrine', 'type': 'DRUG', 'otherNames': ['Ephedrine bolus'], 'description': 'In both the group, the target MAP can be maintained by means of bolus of ephedrine (2.5 mg). The maximal dose for the ephedrine allowed is 25 mg (10 boluses of 2.5 mg), after this threshold a continuous infusion of norepinephrine will be started', 'armGroupLabels': ['MAP 65', 'MAP 80']}, {'name': 'Norepinephrine', 'type': 'DRUG', 'otherNames': ['norepinephrine infusion'], 'description': 'In both the group, the target MAP can be maintained by means of bolus of ephedrine (2.5 mg) or Etilefrine (1 mg). The continuous infusion of norepinephrine, as decided by the attending anesthetist, may be started at any point of the intraoperative period. The starting dose of norepinephrine is the lowest needed to reach the predefined MAP target.', 'armGroupLabels': ['MAP 65', 'MAP 80']}, {'name': 'Etilefrine Hydrochloride bolus', 'type': 'DRUG', 'description': 'The maximal dose for the etilefrine allowed is 10 mg (10 boluses of 1 mg), after this threshold a continuous infusion of norepinephrine will be started', 'armGroupLabels': ['MAP 65', 'MAP 80']}, {'name': 'Use of pulse pressure and stroke volume variation (PPV and SVV); use of Mini Fluid Challenge (mini_FC)', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Hemodynamic optimization'], 'description': 'PPV, SVV and mini\\_FC will guide fluid bolus administration during an episode of intraoperative hypotension, following two predefined algorithms for laparotomic/non laparotomic surgery', 'armGroupLabels': ['MAP 65', 'MAP 80']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Foggia', 'state': 'Apulia', 'country': 'Italy', 'facility': 'Ospedali Riuniti Foggia- Università di Foggia', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}, {'city': 'Modena', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': 'Department of Anesthesia and Intensive Care, University Hospital of Modena', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'facility': 'Policlinico A. Gemelli', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '20089', 'city': 'Rozzano', 'state': 'MILANO', 'country': 'Italy', 'facility': 'Humanitas Research Hospital', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'city': 'Cefalù', 'state': 'Sicily', 'country': 'Italy', 'facility': 'Fondazione Istituto San Raffaele G. Giglio', 'geoPoint': {'lat': 38.03856, 'lon': 14.02285}}, {'zip': '50134', 'city': 'Florence', 'state': 'Tuscany', 'country': 'Italy', 'facility': 'Careggi University Hospital', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Verona', 'state': 'Veneto', 'country': 'Italy', 'facility': 'Unit of Anesthesiology and Intensive Care B, Department of Surgery, Dentistry, Gynecology and Pediatrics, AOUI-University Hospital Integrated Trust of Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'city': 'Alessandria', 'country': 'Italy', 'facility': 'Azienda Ospedaliero - Universitaria SS. Antonio e Biagio e Cesare Arrigo', 'geoPoint': {'lat': 44.90924, 'lon': 8.61007}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'ASST Grande Ospedale Metropolitano Niguarda', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Istituto Nazionale dei Tumori', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'Ospedale Antonio Cardarelli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Pordenone', 'country': 'Italy', 'facility': 'Azienda sanitaria Friuli Occidentale (AsFO]', 'geoPoint': {'lat': 45.95689, 'lon': 12.66051}}, {'city': 'Prato', 'country': 'Italy', 'facility': 'Ospedale Santo Stefano', 'geoPoint': {'lat': 43.8805, 'lon': 11.09699}}, {'city': 'Reggio Emilia', 'country': 'Italy', 'facility': "Ospedale S. Anna di Castelnovo ne' Monti", 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'city': 'Roma', 'country': 'Italy', 'facility': "Sant'Eugenio ASL Roma 2:", 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Sassari', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria di Sassari', 'geoPoint': {'lat': 40.72586, 'lon': 8.55552}}, {'city': 'Torino', 'country': 'Italy', 'facility': 'Ospedale Molinette', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Trento', 'country': 'Italy', 'facility': 'Ospedale Santa Chiara di Trento', 'geoPoint': {'lat': 46.06787, 'lon': 11.12108}}], 'overallOfficials': [{'name': 'Antonio Messina', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milano, Italy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Humanitas Clinical and Research Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Antonio Messina', 'investigatorAffiliation': 'Humanitas Clinical and Research Center'}}}}