[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626783":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":20,"studyPopulation":20,"armGroups":60,"interventions":74,"overallOfficials":20,"centralContacts":87,"locations":20,"responsibleParty":93,"collaborators":20,"id":97,"slug":20,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":98,"sex":104,"minAge":105,"maxAge":20,"enrollmentInfo":106,"targetDuration":20,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":116,"overallStatus":120,"whyStopped":20,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":20},{"fullName":5,"class":6},"Air Force Military Medical University, China","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"incidence of acute kidney injury","Postoperative acute kidney injury (AKI) was diagnosed and staged according to the Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for Acute Kidney Injury (2012). AKI was defined as the presence of any of the following criteria within 7 days after surgery: an increase in serum creatinine by ≥ 0.3 mg\u002FdL (≥ 26.5 μmol\u002FL) within 48 hours; an increase in serum creatinine to ≥ 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or urine volume \\\u003C 0.5 mL\u002Fkg\u002Fh for 6 consecutive hours. Baseline serum creatinine was defined as the most recent preoperative value available within 3 months prior to surgery.","from end of surgery to 7 days after surgery",[14,18,21,24,28,32,36,38,41,44,46],{"measure":15,"description":16,"timeFrame":17},"Severity of acute kidney injury","AKI severity was further classified into three stages: stage 1 was defined as serum creatinine 1.5-1.9 times baseline or an increase of ≥ 0.3 mg\u002FdL (≥ 26.5 μmol\u002FL), or urine output \\\u003C 0.5 mL\u002Fkg\u002Fh for 6-12 hours; stage 2 as serum creatinine 2.0-2.9 times baseline, or urine output \\\u003C 0.5 mL\u002Fkg\u002Fh for ≥ 12 hours; and stage 3 as serum creatinine 3.0 times baseline, or an increase in serum creatinine to ≥ 4.0 mg\u002FdL (≥ 353.6 μmol\u002FL), or initiation of renal replacement therapy, or urine output \\\u003C 0.3 mL\u002Fkg\u002Fh for ≥ 24 hours, or anuria for ≥ 12 hours","from end of surgery to discharge from hospital, at an average of 7 days",{"measure":19,"description":20,"timeFrame":17},"number of patients with post-hepatectomy liver failure",null,{"measure":22,"description":23,"timeFrame":17},"number of patients with major cardiac complications","heart failure, myocardial ischemia and new on-set arrythmia",{"measure":25,"description":26,"timeFrame":27},"volume of blood loss","The method for calculating blood loss is the volume in the suction canister plus the estimated amount of blood on the gauze","from start of surgery to end of surgery, at an average of 3 hours",{"measure":29,"description":30,"timeFrame":31},"numerical rating scale of surgeon's satisfaction to the surgical field","0 is extremely unsatisfied, 10 is extremely satisfied","at the end of the surgery",{"measure":33,"description":34,"timeFrame":35},"control of central venous pressure during resection","0, uncontrolled central venous pressure (CVP), defined as the target CVP of \\\u003C 5 cmH₂O was achieved for at least 75% of the resection period; 1, defined as the target CVP of \\\u003C 5 cmH₂O was achieved for 50% -75% of the resection period; 1, defined as the target CVP of \\\u003C 5 cmH₂O was achieved for less than 50% of the resection period","from start of resection to end of removal of the liver lesions ,at an average of 2 hours",{"measure":37,"description":20,"timeFrame":27},"dose of norepinephrine",{"measure":39,"description":40,"timeFrame":27},"frequency of hypotension","hypotension is defined as mean arterial pressure less than 60 mmHg",{"measure":42,"description":20,"timeFrame":43},"arterial lactate level","upon completion of surgery，that is, end of incision suture，at an average of 3 hours after anesthesia induction",{"measure":42,"description":20,"timeFrame":45},"When the liver lesions are removed，at an average of 2 hours after anesthesia induction",{"measure":47,"description":48,"timeFrame":49},"surgical field bleeding score","0=no bleeding; 1=minor bleeding, no aspiration required; 2=minor bleeding, aspiration required; 3 = minor bleeding, frequent aspiration required ; 4 = moderate bleeding, visible only aspiration; 5 = severe bleeding, frequent aspiration required, very hard to perform surgery","at the end of the surgery, ，at an average of 3 hours after anesthesia induction",{"allocation":51,"interventionModel":52,"interventionModelDescription":20,"primaryPurpose":53,"observationalModel":20,"timePerspective":20,"maskingInfo":54},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":55,"maskingDescription":20,"whoMasked":56},"TRIPLE",[57,58,59],"PARTICIPANT","CARE_PROVIDER","OUTCOMES_ASSESSOR",[61,66,70],{"label":62,"type":63,"description":20,"interventionNames":64},"restrictive","EXPERIMENTAL",[65],"Other: restrictive fluid infusion",{"label":67,"type":63,"description":20,"interventionNames":68},"Restrictive plus preload",[65,69],"Other: preload",{"label":71,"type":63,"description":20,"interventionNames":72},"restrictive plus preload plus nitro",[65,69,73],"Other: nitro",[75,79,83],{"type":6,"name":76,"description":77,"armGroupLabels":78,"otherNames":20},"restrictive fluid infusion","Fluid infusion is restricted at 2 ml·kg- 1·h- 1 from the moment the patient arrive in the operating room to immediately after the liver lesions are removed",[67,62,71],{"type":6,"name":80,"description":81,"armGroupLabels":82,"otherNames":20},"preload","6 ml·kg- 1·h- 1 of hydroxyethyl starch solution is infused before anesthesia",[67,71],{"type":6,"name":84,"description":85,"armGroupLabels":86,"otherNames":20},"nitro","Nitroglycerin is infused from start of anesthesia to immediately after the liver lesions are removed.The starting infusion rates of nitroglycerin is 0.5 μg·kg- 1·min- 1 . If the speed of administration requires adjustment, nitroglycerin is added or decreased by 0.1 μg·kg- 1·min- 1.",[71],[88],{"name":89,"role":90,"phone":91,"phoneExt":20,"email":92},"Zhihong Lu","CONTACT","86-13891975018","deerlu23@163.com",{"type":94,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Zhihong LU","Professor","100626783",false,"NCT07440121","Optimized Strict Fluid Management Helps Improve Endpoints After Liver Dissection","The Effect of Different Fluid Therapy on Major Postoperative Morbidity in Patients Undergoing Non-donor Hepatectomy: a Pilot Trial","SHIELD-pilot","Inclusion Criteria:\n\n* scheduled for elective hepatectomy under general anesthesia\n* age ≥18 yrs old\n\nExclusion Criteria:\n\n* American society of anesthesiologists status over 3\n* existed kidney disease or renal dysfunction\n* severe cardiac or respiratory dysfunction\n* neurological or psychiatric disease\n* Child-Pugh class C (score 10-15)","ALL","18 Years",{"count":107,"type":108},90,"ESTIMATED","INTERVENTIONAL",[111],"NA","During hepatectomy, surgeons often prefer to restrict fluid intake, believing that this can lower central venous pressure (CVP) and reduce intraoperative blood loss. However, fluid restriction may lead to inadequate perfusion of vital organs and even contribute to postoperative organ dysfunction, such as acute kidney injury (AKI). Therefore, this study aims to compare the effects of restrictive versus liberal fluid therapy on major complications following hepatectomy.",[114,115],"Anesthesia","Surgery",[117,118,119],"fluid therapy","hepatectomy","acute kidney injury","NOT_YET_RECRUITING","2026-02-25",{"date":123,"type":124},"2026-02-27","ACTUAL",{"date":126,"type":108},"2026-04-02",{"date":128,"type":108},"2027-02-02",{"name":95,"class":6}]