[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606199":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":36,"centralContacts":41,"locations":53,"responsibleParty":201,"collaborators":203,"id":207,"slug":208,"hasResults":209,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":209,"sex":215,"minAge":216,"maxAge":46,"enrollmentInfo":217,"targetDuration":46,"studyType":220,"phases":221,"briefSummary":223,"conditions":224,"keywords":227,"overallStatus":123,"whyStopped":46,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":249},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Balanced Gelatin Solution","EXPERIMENTAL","Patients randomized to the balanced gelatin group receive balanced gelatin solution (4% succinylated gelatin in a balanced crystalloid carrier) for volume expansion during the surgical procedure, guided by a stroke volume (SV) monitoring protocol. The study fluid management may continue for up to 24 hours post-randomization according to clinical needs. The cumulative dose of balanced gelatin is capped at 30 mL\u002Fkg (ideal body weight) within the first 24 hours; once reached or when the study fluid is unavailable, Ringer's acetate is used for subsequent resuscitation.",[13],"Drug: Balanced Gelatin Solution",{"label":15,"type":16,"description":17,"interventionNames":18},"Crystalloid Solution","ACTIVE_COMPARATOR","Patients randomized to the crystalloid group receive acetate Ringer's solution as the sole resuscitation fluid during emergency abdominal surgery for sepsis, according to the same goal-directed protocol guided by stroke volume monitoring. No gelatin solution or lactate-containing crystalloids will be administered within the first 24 hours post-randomization. The total volume of crystalloid infusion is not limited.",[19],"Drug: Acetate Ringer's Solution",[21,29],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Description: Balanced gelatin solution (4% succinylated gelatin in a balanced crystalloid carrier). Administered as the primary resuscitation fluid during the intraoperative period and may be continued into the first 24 postoperative hours if clinically indicated and available. Infusion follows a stroke volume-guided, goal-directed fluid therapy protocol. The total dose of the study fluid is capped at 30 mL\u002Fkg (ideal body weight) within 24 hours. If the maximum dose is reached or the study fluid is no longer available postoperatively, additional resuscitation is provided with Ringer's acetate solution.",[9],[26,27,28],"Succinylated Gelatin 4%","Gelatin Infusion","Gelaspan",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Acetate Ringer's Solution","Description: Acetate Ringer's solution, a balanced crystalloid, administered as the sole resuscitation fluid in patients with sepsis undergoing emergency abdominal surgery. Fluid therapy follows the same stroke volume-guided, goal-directed protocol as the experimental arm. This regimen is maintained throughout the intraoperative period and the first 24 postoperative hours to ensure the exclusion of any exogenous colloids or lactate-containing solutions. There is no upper limit for the total volume of crystalloid infusion.",[15],[34,35],"Balanced Crystalloid Solution","Ringer's Acetate",[37],{"name":38,"affiliation":39,"role":40},"Changhong Miao, MD","Fudan University","PRINCIPAL_INVESTIGATOR",[42,48],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Jian Huang, MD","CONTACT","+8618018684575",null,"huang.jian1@zs-hospital.sh.cn",{"name":49,"role":44,"phone":50,"phoneExt":51,"email":52},"Jing Zhong, MD","+86-021-64041990","3997","zhong.jing@zs-hospital.sh.cn",[54,75,91,106,121,139,155,170,186],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"The First Affiliated Hospital, Sun Yat-sen University","NOT_YET_RECRUITING","Guangzhou","Guangdong","510080","China","CN",{"type":63,"coordinates":64},"Point",[65,66],113.25,23.11667,{"lat":66,"lon":65},[69,73],{"name":70,"role":44,"phone":71,"phoneExt":46,"email":72},"Site Investigator","+86-020-87755766","zsyyyb@mail.sysu.edu.cn",{"name":74,"role":40,"phone":46,"phoneExt":46,"email":46},"Xia Feng",{"facility":76,"status":56,"city":77,"state":78,"zip":79,"country":60,"countryCode":61,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Zhongda Hospital, Southeast University","Nanjing","Jiangsu","210009",{"type":63,"coordinates":81},[82,83],118.77778,32.06167,{"lat":83,"lon":82},[86,89],{"name":70,"role":44,"phone":87,"phoneExt":46,"email":88},"+86-025-83272015","ZDLL2015@163.com",{"name":90,"role":40,"phone":46,"phoneExt":46,"email":46},"Jie Sun",{"facility":92,"status":56,"city":93,"state":78,"zip":94,"country":60,"countryCode":61,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"The First Affiliated Hospital of Soochow University","Suzhou","215006",{"type":63,"coordinates":96},[97,98],120.59538,31.30408,{"lat":98,"lon":97},[101,104],{"name":70,"role":44,"phone":102,"phoneExt":46,"email":103},"+86-0512-67972858","sdfyy8040@126.com",{"name":105,"role":40,"phone":46,"phoneExt":46,"email":46},"Fuhai Ji",{"facility":107,"status":56,"city":108,"state":78,"zip":109,"country":60,"countryCode":61,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Affiliated Hospital of Xuzhou Medical University","Xuzhou","221000",{"type":63,"coordinates":111},[112,113],117.28386,34.20442,{"lat":113,"lon":112},[116,119],{"name":70,"role":44,"phone":117,"phoneExt":46,"email":118},"+86-0516-85609999","xyfyec@163.com",{"name":120,"role":40,"phone":46,"phoneExt":46,"email":46},"Zhiping Wang",{"facility":122,"status":123,"city":124,"state":125,"zip":126,"country":60,"countryCode":61,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Zhongshan Hospital, Fudan University","RECRUITING","Shanghai","Shanghai Municipality","200032",{"type":63,"coordinates":128},[129,130],121.45806,31.22222,{"lat":130,"lon":129},[133,134,135,136,138],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},{"name":49,"role":44,"phone":50,"phoneExt":51,"email":52},{"name":38,"role":40,"phone":46,"phoneExt":46,"email":46},{"name":49,"role":137,"phone":46,"phoneExt":46,"email":46},"SUB_INVESTIGATOR",{"name":43,"role":137,"phone":46,"phoneExt":46,"email":46},{"facility":140,"status":56,"city":141,"state":142,"zip":143,"country":60,"countryCode":61,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"West China Hospital of Sichuan University","Chengdu","Sichuan","610041",{"type":63,"coordinates":145},[146,147],104.06667,30.66667,{"lat":147,"lon":146},[150,153],{"name":70,"role":44,"phone":151,"phoneExt":46,"email":152},"+86-028-85422851","hxlcyjglb@163.com",{"name":154,"role":40,"phone":46,"phoneExt":46,"email":46},"Tao Zhu",{"facility":156,"status":56,"city":157,"state":157,"zip":158,"country":60,"countryCode":61,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Tianjin Medical University General Hospital","Tianjing","300052",{"type":63,"coordinates":160},[161,162],120.77196,31.46583,{"lat":162,"lon":161},[165,168],{"name":70,"role":44,"phone":166,"phoneExt":46,"email":167},"+86-022-60362237","keyanchu@yahoo.com.cn",{"name":169,"role":40,"phone":46,"phoneExt":46,"email":46},"Yonghao Yu",{"facility":171,"status":56,"city":172,"state":173,"zip":174,"country":60,"countryCode":61,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"The Second Affiliated Hospital, Zhejiang University School of Medicine","Hangzhou","Zhejiang","310058",{"type":63,"coordinates":176},[177,178],120.16142,30.29365,{"lat":178,"lon":177},[181,184],{"name":70,"role":44,"phone":182,"phoneExt":46,"email":183},"+86-0571-8820810","global_zusm@zju.edu.cn",{"name":185,"role":40,"phone":46,"phoneExt":46,"email":46},"Min Yan",{"facility":187,"status":56,"city":188,"state":173,"zip":189,"country":60,"countryCode":61,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University (WMU)","Wenzhou","325000",{"type":63,"coordinates":191},[192,193],120.66682,27.99942,{"lat":193,"lon":192},[196,199],{"name":70,"role":44,"phone":197,"phoneExt":46,"email":198},"+86-0577-85676879","feykjkcy@126.com",{"name":200,"role":40,"phone":46,"phoneExt":46,"email":46},"Wangning Shangguan",{"type":202,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR",[204],{"name":205,"class":206},"B. Braun Medical International Trading Company Ltd.","INDUSTRY","100606199","phase-4-gelaspan-vs-crystalloid-therapy-in-sepsis-100606199",false,"NCT07172451","Gelaspan vs Crystalloid Therapy in Sepsis","Efficacy and Safety of Balanced Gelatin Solution for Fluid Infusion in Sepsis Patients Undergoing Emergency Abdominal Surgery: A Multicenter, Adaptive Designed, Randomized Controlled Trial","SPACES","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Diagnosis of sepsis according to the Sepsis-3 definition, caused by intra-abdominal infection, and requiring emergency abdominal surgery for source control.\n* Sequential Organ Failure Assessment (SOFA-2) score ≥ 2 (determined by the most recent available clinical data) and blood lactate \\> 2 mmol\u002FL (measured within 6 hours prior to enrollment).\n* Subject or legal representative can understand the study purpose and provide written informed consent.\n\nExclusion Criteria:\n\n* Received any dose of artificial colloids within 24 hours prior to randomization.\n* Predicted mortality within 48 hours (ASA physical status class ≥ V).\n* Atrial fibrillation or congestive heart failure.\n* Severe Acute Respiratory Distress Syndrome (ARDS).\n* Preoperative coagulation dysfunction or receiving anticoagulant therapy.\n* Preoperative requirement for renal replacement therapy (long-term or intermittent, including hemodialysis or peritoneal dialysis).\n* Acute burns exceeding 10% of the total body surface area.\n* Severe hepatic impairment.\n* Severe electrolyte disturbance.\n* Pregnancy or breastfeeding.\n* Known allergy to gelatin.\n* Current participation in other interventional clinical trials.\n* Other conditions that the investigator considers inappropriate for inclusion.","ALL","18 Years",{"count":218,"type":219},318,"ESTIMATED","INTERVENTIONAL",[222],"PHASE4","The goal of this randomized clinical trial is to evaluate whether balanced gelatin solution is more effective and safe than balanced crystalloid solution for perioperative fluid management in adults with sepsis undergoing emergency abdominal surgery. Sepsis often causes severe fluid loss from the bloodstream into tissues, leading to low blood pressure, impaired organ function, and the need for urgent fluid resuscitation. Balanced gelatin, a colloid solution, may help maintain intravascular volume more effectively than crystalloid alone.\n\nIn this study, participants are randomly assigned in a 1:1 ratio to receive either balanced gelatin or Ringer's acetate during surgery and in the first 24 hours afterward. All patients receive standardized anesthesia care, goal-directed fluid therapy, and protocolized use of vasoactive drugs. The main questions the study aims to answer are:\n\n* Does balanced gelatin reduce positive fluid balance within 24 hours after surgery?\n* Does it improve hemodynamic stability during the early postoperative period?\n* What effects does balanced gelatin have on kidney function, microcirculation, postoperative recovery, and other clinical outcomes?\n\nParticipants will be followed throughout hospitalization and contacted again on postoperative day 28 and day 90 to assess survival, complications, and health-related quality of life. The trial is double-blind, meaning that patients, clinicians, and outcome assessors do not know which fluid is being used. An independent Data and Safety Monitoring Board will oversee patient safety during the study.\n\nThe findings of this trial are expected to provide important evidence to guide perioperative fluid resuscitation strategies for septic patients undergoing emergency surgery.",[225,226],"Sepsis","Intra-Abdominal Infections",[228,229,230,231,232,233,234,235,236,237,238,239],"Balanced gelatin solution","Succinylated gelatin","Crystalloid","Ringer's acetate","Fluid resuscitation","Goal-directed fluid therapy","Emergency abdominal surgery","Microcirculation","Hemodynamic stabilization","SOFA score","Lactate clearance","Randomized controlled trial","2026-03-17",{"date":242,"type":243},"2026-03-20","ACTUAL",{"date":245,"type":243},"2026-02-13",{"date":247,"type":219},"2028-12-30",{"name":5,"class":6},9]