[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053808":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":48,"studyPopulation":48,"armGroups":60,"interventions":73,"overallOfficials":48,"centralContacts":83,"locations":93,"responsibleParty":116,"collaborators":48,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":120,"sex":126,"minAge":127,"maxAge":48,"enrollmentInfo":128,"targetDuration":48,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":139,"overallStatus":144,"whyStopped":48,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"Suez Canal University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":48},[9],{"measure":10,"description":11,"timeFrame":12},"Total intraoperative crystalloid administration","Total volume of crystalloid administered intraoperatively from induction of anesthesia until skin closure, measured in milliliters.","From induction of anesthesia until skin closure (intraoperative period)",[14,18,21,25,29,33,36,39,42,45],{"measure":15,"description":16,"timeFrame":17},"Number of Participants with Postoperative Pulmonary Complications","Incidence of postoperative pulmonary complications defined according to European Perioperative Clinical Outcome (EPCO) criteria using clinical, radiological, and laboratory findings","Within seven postoperative days",{"measure":19,"description":20,"timeFrame":17},"Number of Participants With Acute Kidney Injury","Incidence of acute kidney injury defined according to KDIGO criteria based on serum creatinine changes and urine output.",{"measure":22,"description":23,"timeFrame":24},"Lactate Levels","Arterial lactate concentration measured in mmol\u002FL serially during the perioperative period","After induction of anesthesia, at the end of surgery, and 24 hours postoperatively",{"measure":26,"description":27,"timeFrame":28},"Urine Output","Hourly intraoperative urine output measured from urinary catheter collection and expressed as total mL\u002Fkg\u002Fhour.","From induction of anesthesia until skin closure (Intraoperative period)",{"measure":30,"description":31,"timeFrame":32},"Intraoperative Blood Loss","Estimated intraoperative blood loss measured in milliliters using suction canister volume after subtraction of irrigation fluids in addition to surgical field assessment.","From surgical incision until skin closure (Intraoperative period)",{"measure":34,"description":35,"timeFrame":28},"Duration of Rescue Norepinephrine Requirement","Cumulative duration of rescue open-label norepinephrine infusion for persistent hemodynamic instability measured in minutes.",{"measure":37,"description":38,"timeFrame":28},"Duration of Intraoperative Hypotension","Cumulative duration of intraoperative hypotension defined as mean arterial pressure below 65 mmHg, measured in minutes using nvasive arterial blood pressure monitoring.",{"measure":40,"description":41,"timeFrame":17},"Number of Participants Admitted to the Intensive Care Unit","Number of participants requiring admission to the intensive care unit during the postoperative period.",{"measure":43,"description":44,"timeFrame":17},"Duration of Postoperative Hospital Stay","Total postoperative hospital stay measured in days during the first seven postoperative days",{"measure":46,"description":47,"timeFrame":17},"Number of Participants With Postoperative Surgical Complications","Incidence of postoperative surgical complications assessed according to Clavien-Dindo classification grade II or higher during the first seven postoperative days.",null,{"allocation":50,"interventionModel":51,"interventionModelDescription":48,"primaryPurpose":52,"observationalModel":48,"timePerspective":48,"maskingInfo":53},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":54,"maskingDescription":48,"whoMasked":55},"QUADRUPLE",[56,57,58,59],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[61,67],{"label":62,"type":63,"description":64,"interventionNames":65},"Norepinephrine Group","EXPERIMENTAL","Participants will receive continuous norepinephrine infusion at a fixed dose of 0.03 µg\u002Fkg\u002Fmin initiated immediately after induction of anesthesia and continued until skin closure within a protocolized hemodynamic management strategy.",[66],"Drug: Norepinephrine",{"label":68,"type":69,"description":70,"interventionNames":71},"Control Group","PLACEBO_COMPARATOR","Participants will receive an equivalent volume normal saline infusion initiated immediately after induction of anesthesia and continued until skin closure within the same protocolized hemodynamic management strategy.",[72],"Other: Placebo",[74,79],{"type":75,"name":76,"description":77,"armGroupLabels":78,"otherNames":48},"DRUG","Norepinephrine","Continuous norepinephrine infusion administered at a fixed dose of 0.03 µg\u002Fkg\u002Fmin from induction of anesthesia until skin closure.",[62],{"type":6,"name":80,"description":81,"armGroupLabels":82,"otherNames":48},"Placebo","Equivalent volume normal saline infusion administered from induction of anesthesia until skin closure at the same infusion rate as the active intervention to maintain blinding within a protocolized hemodynamic management strategy.",[68],[84,89],{"name":85,"role":86,"phone":87,"phoneExt":48,"email":88},"Mohammad Elhossieny Salama, MD","CONTACT","+201016865861","MohammadElhossieny88@med.suez.edu.eg",{"name":90,"role":86,"phone":91,"phoneExt":48,"email":92},"Mahmoud Hosny Ahmed, MD","+201097920831","M.hosnawy@med.suez.edu.eg",[94],{"facility":95,"status":48,"city":96,"state":97,"zip":98,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":106,"contacts":107},"Suez Canal University Hospitals","Ismailia","Ismailia Governorate","41522","Egypt","EG",{"type":102,"coordinates":103},"Point",[104,105],32.27225,30.60427,{"lat":105,"lon":104},[108,112,114],{"name":109,"role":86,"phone":110,"phoneExt":48,"email":111},"Muhammad Elhossieny Salama, MD","01016865861","mohammadelhossieny88@med.suez.edu.eg",{"name":109,"role":113,"phone":48,"phoneExt":48,"email":48},"PRINCIPAL_INVESTIGATOR",{"name":90,"role":115,"phone":48,"phoneExt":48,"email":48},"SUB_INVESTIGATOR",{"type":117,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR","100053808","pro-stress-trial-proactive-low-dose-norepinephrine-to-reduce-intraoperative-fluid-administration-in-patients-at-high-risk-for-postoperative-pulmonary-complications-undergoing-laparoscopic-abdominal-surgery-100053808",false,"NCT07627360","PRO STRESS Trial: Proactive Low-Dose Norepinephrine to Reduce Intraoperative Fluid Administration in Patients at High-Risk for Postoperative Pulmonary Complications Undergoing Laparoscopic Abdominal Surgery","Proactive Low-Dose Norepinephrine to Reduce Intraoperative Fluid Administration in Patients at High-Risk for Postoperative Pulmonary Complications Undergoing Laparoscopic Abdominal Surgery: A Randomized Controlled Trial","PRO STRESS","Inclusion Criteria:\n\n* Adult patients aged 18 years or older.\n* American Society of Anesthesiologists (ASA) physical status I-III.\n* Scheduled for elective laparoscopic major abdominal surgery under general anesthesia with an expected duration greater than 2 hours.\n* Patients with ARISCAT score ≥ 45 indicating high risk for postoperative pulmonary complications.\n\nExclusion Criteria:\n\n* Known hypersensitivity to norepinephrine.\n* Severe left ventricular dysfunction with ejection fraction \\\u003C 35%.\n* Significant cardiac arrhythmia.\n* Uncontrolled hypertension defined as systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg.\n* End-stage renal disease.\n* Requirement for vasopressor support before induction of anesthesia.\n* Emergency surgery.","ALL","18 Years",{"count":129,"type":130},130,"ESTIMATED","INTERVENTIONAL",[133],"NA","Intraoperative hypotension is commonly treated with fluid administration; however, excessive fluid therapy may contribute to postoperative pulmonary complications. This randomized double-blind controlled trial evaluates whether proactive administration of fixed low-dose norepinephrine reduces intraoperative crystalloid administration while maintaining hemodynamic stability in high-risk patients undergoing laparoscopic abdominal surgery. One hundred and thirty patients will be randomized to receive either norepinephrine infusion (0.03 µg\u002Fkg\u002Fmin) or placebo from induction until skin closure within a protocolized hemodynamic strategy guided by mean arterial pressure and pulse pressure variation.",[136,137,138],"Intraoperative Hypotension","Postoperative Pulmonary Complications (PPCs)","Fluid Over-load",[76,140,141,142,143],"Fluid Therapy","Pulmonary Complications","Abdominal Surgery","Vasopressor","NOT_YET_RECRUITING","2026-07-10",{"date":147,"type":148},"2026-07-13","ACTUAL",{"date":150,"type":130},"2026-07-15",{"date":152,"type":130},"2026-11",{"name":5,"class":6},1]