[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658649":3},{"organization":4,"outcomesModule":7,"designInfo":83,"detailedDescription":91,"studyPopulation":88,"armGroups":92,"interventions":106,"overallOfficials":125,"centralContacts":132,"locations":137,"responsibleParty":156,"collaborators":159,"id":161,"slug":162,"hasResults":163,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":88,"eligibilityCriteria":167,"healthyVolunteers":163,"sex":168,"minAge":169,"maxAge":88,"enrollmentInfo":170,"targetDuration":88,"studyType":173,"phases":174,"briefSummary":176,"conditions":177,"keywords":182,"overallStatus":139,"whyStopped":88,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":201},{"fullName":5,"class":6},"The Leningrad Regional Clinical Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":63},[9],{"measure":10,"description":11,"timeFrame":12},"Core body temperature at admission to the intensive care unit","Oesophageal temperature measured at the time of transfer of the participant from the operating room to the intensive care unit, in degrees Celsius.","At transfer to the intensive care unit, up to 12 hours after skin incision",[14,18,22,26,29,32,36,39,43,46,50,54,57,60],{"measure":15,"description":16,"timeFrame":17},"Perioperative axillary temperature","Axillary temperature measured with a contact thermometer. Measured in degrees Celsius.","Before induction of anaesthesia, hourly during surgery, and at admission to the intensive care unit, up to 12 hours",{"measure":19,"description":20,"timeFrame":21},"Perioperative oesophageal temperature","Core temperature measured with an oesophageal probe. Measured in degrees Celsius.","Hourly from 1 hour after start of surgery until admission to the intensive care unit, up to 12 hours",{"measure":23,"description":24,"timeFrame":25},"Proportion of participants requiring norepinephrine infusion","Number of participants who received an intraoperative norepinephrine infusion, divided by the number of participants analysed in the group, expressed as a percentage.","Intraoperative period, up to 12 hours",{"measure":27,"description":28,"timeFrame":25},"Time from skin incision to initiation of norepinephrine infusion","Interval between skin incision and the start of norepinephrine infusion, assessed only in participants who received norepinephrine. Measured in minutes.",{"measure":30,"description":31,"timeFrame":25},"Norepinephrine infusion rate","Rate of intraoperative norepinephrine infusion, assessed only in participants who received norepinephrine. Measured in micrograms per kilogram per minute.",{"measure":33,"description":34,"timeFrame":35},"Volume of intraoperative crystalloid infusion","Total volume of balanced crystalloid solutions administered intravenously during surgery. Measured in millilitres.","From skin incision to end of surgery, up to 12 hours",{"measure":37,"description":38,"timeFrame":35},"Intraoperative urine output","Total volume of urine collected during surgery. Measured in millilitres.",{"measure":40,"description":41,"timeFrame":42},"Stroke volume measured by tetrapolar impedance rheography","Stroke volume assessed non-invasively by tetrapolar impedance rheography. Measured in millilitres.","From before induction of anaesthesia, hourly during surgery, up to 12 hours",{"measure":44,"description":45,"timeFrame":42},"Cardiac output measured by tetrapolar impedance rheography","Cardiac output assessed non-invasively by tetrapolar impedance rheography. Measured in litres per minute.",{"measure":47,"description":48,"timeFrame":49},"Change in extracellular fluid volume measured by tetrapolar impedance rheography","Relative change in extracellular fluid volume assessed by tetrapolar impedance rheography. Expressed as a percentage.","From start of surgery to end of surgery, up to 12 hours",{"measure":51,"description":52,"timeFrame":53},"Base excess in venous blood","Base excess determined by venous blood gas analysis. Measured in millimoles per litre.","Postoperative day 1",{"measure":55,"description":56,"timeFrame":53},"Plasma lactate concentration","Lactate concentration determined in venous blood. Measured in millimoles per litre.",{"measure":58,"description":59,"timeFrame":53},"Serum C-reactive protein concentration","C-reactive protein concentration determined in venous blood. Measured in milligrams per litre.",{"measure":61,"description":62,"timeFrame":53},"Total SOFA score","Sequential Organ Failure Assessment score, calculated as the sum of six organ system subscores. Total score ranges from 0 to 24, with higher scores indicating greater organ dysfunction.",[64,68,71,74,77,80],{"measure":65,"description":66,"timeFrame":67},"Proportion of screened participants who were randomised","Feasibility outcome. Number of randomised participants divided by the number of patients screened for eligibility, expressed as a percentage.","From start of enrolment through study completion, up to 32 months",{"measure":69,"description":70,"timeFrame":67},"Proportion of eligible participants who provided informed consent","Feasibility outcome. Number of participants who provided written informed consent divided by the number of patients who met the eligibility criteria, expressed as a percentage.",{"measure":72,"description":73,"timeFrame":67},"Recruitment rate","Feasibility outcome. Number of randomised participants per month of enrolment.",{"measure":75,"description":76,"timeFrame":67},"Adherence to the allocated intervention","Feasibility outcome. Number of randomised participants who received the allocated intervention in full, divided by the number of randomised participants, expressed as a percentage.",{"measure":78,"description":79,"timeFrame":67},"Proportion of randomised participants with analysable data","Feasibility outcome. Number of randomised participants whose data were available for analysis of the clinical outcome measures, divided by the number of randomised participants, expressed as a percentage.",{"measure":81,"description":82,"timeFrame":67},"Completeness of data for the primary outcome measure","Feasibility outcome. Number of analysed participants with a recorded value of the primary outcome measure, divided by the number of analysed participants, expressed as a percentage.",{"allocation":84,"interventionModel":85,"interventionModelDescription":86,"primaryPurpose":87,"observationalModel":88,"timePerspective":88,"maskingInfo":89},"RANDOMIZED","PARALLEL","Two parallel groups; all participants receive forced-air warming, with the study group additionally receiving actively warmed intravenous fluids.","PREVENTION",null,{"masking":90,"maskingDescription":88,"whoMasked":88},"NONE","Design and setting.\n\nSingle-centre, randomised, parallel-group, open-label pilot trial conducted at a regional clinical hospital in Saint Petersburg, Russian Federation. Participants are allocated in a 1:1 ratio to a control group or a study group.\n\nAnaesthesia and warming protocol.\n\nAll participants receive general anaesthesia according to a standardised institutional protocol, and ambient operating room temperature is kept constant. In both groups, forced-air warming is applied through an upper body blanket at an airflow temperature of 37 °C from induction of anaesthesia until the end of surgery. In the control group, balanced crystalloid solutions are stored at 23 °C and infused without additional warming. In the study group, the same solutions are actively warmed to a target temperature of 39 °C using a medical fluid warmer positioned as close as possible to the venous access site.\n\nMeasurements.\n\nAxillary and oesophageal temperature are recorded before induction of anaesthesia, hourly during surgery, and at transfer to the intensive care unit. Haemodynamic variables, the use and infusion rate of norepinephrine, intraoperative crystalloid volume and urine output are recorded throughout surgery. Stroke volume, cardiac output and extracellular fluid volume are assessed by tetrapolar impedance rheography. Base excess, plasma lactate, C-reactive protein and the SOFA score are recorded on the first postoperative day.\n\nRandomisation and allocation concealment.\n\nThe allocation sequence is generated using random number tables. Allocation is concealed by sequentially numbered, sealed, opaque envelopes, opened after eligibility is confirmed and written informed consent is obtained. Blinding of the anaesthesia team is not feasible because of the nature of the intervention.\n\nWithdrawal criteria.\n\nParticipants are withdrawn from analysis in case of withdrawal of informed consent, errors in data recording, or intraoperative change in the extent of the planned surgical procedure.\n\nFeasibility assessment.\n\nIn addition to the clinical outcome measures, the following feasibility parameters are recorded: the proportion of screened patients who are eligible and randomised, the proportion of eligible patients who consent, adherence to the allocated intervention, the proportion of randomised participants with analysable data, and completeness of data for the primary outcome measure. These parameters will be used to determine whether a definitive multicentre trial is feasible and to inform its sample size.",[93,100],{"label":94,"type":95,"description":96,"interventionNames":97},"Control group","ACTIVE_COMPARATOR","Forced-air warming applied through an upper body blanket at an airflow temperature of 37 °C from induction of anaesthesia until the end of surgery, combined with intravenous infusion of balanced crystalloid solutions stored at 23 °C and administered without additional warming.",[98,99],"Device: Forced-air warming","Other: Unwarmed intravenous fluids",{"label":101,"type":102,"description":103,"interventionNames":104},"Study group","EXPERIMENTAL","Forced-air warming applied through an upper body blanket at an airflow temperature of 37 °C from induction of anaesthesia until the end of surgery, combined with intravenous infusion of the same balanced crystalloid solutions actively warmed to a target temperature of 39 °C by a medical fluid warmer positioned as close as possible to the venous access site.",[98,105],"Device: Intravenous fluid warming",[107,114,120],{"type":108,"name":109,"description":110,"armGroupLabels":111,"otherNames":112},"DEVICE","Forced-air warming","Forced-air warming system with an upper body blanket; airflow temperature set at 37 °C; applied identically in both groups from induction of anaesthesia until the end of surgery.",[94,101],[113],"WarmTouch WT-5900",{"type":108,"name":115,"description":116,"armGroupLabels":117,"otherNames":118},"Intravenous fluid warming","Balanced crystalloid solutions actively warmed to a target temperature of 39 °C using a medical fluid warmer; the infusion line is placed inside the heating element as close as possible to the venous access site.",[101],[119],"IRIS medical fluid warmer",{"type":121,"name":122,"description":123,"armGroupLabels":124,"otherNames":88},"OTHER","Unwarmed intravenous fluids","Balanced crystalloid solutions stored at an ambient temperature of 23 °C and administered intravenously without additional warming.",[94],[126,129],{"name":127,"affiliation":5,"role":128},"Valentin S Kozlov, MD","PRINCIPAL_INVESTIGATOR",{"name":130,"affiliation":131,"role":128},"Ionas S Simutis, MD, Dsc","North-Western State Medical University named after I.I.Mechnikov",[133],{"name":127,"role":134,"phone":135,"phoneExt":88,"email":136},"CONTACT","+7-931-250-79-30","kozlov.vs@47lokb.ru",[138],{"facility":5,"status":139,"city":140,"state":88,"zip":141,"country":142,"countryCode":143,"cosmosGeoPoint":144,"geoPoint":149,"contacts":150},"RECRUITING","Saint Petersburg","194291","Russia","RU",{"type":145,"coordinates":146},"Point",[147,148],30.31413,59.93863,{"lat":148,"lon":147},[151,152,155],{"name":127,"role":134,"phone":135,"phoneExt":88,"email":136},{"name":153,"role":154,"phone":88,"phoneExt":88,"email":88},"Alexey S Rumyantsev-Aleksandrov, MD","SUB_INVESTIGATOR",{"name":127,"role":128,"phone":88,"phoneExt":88,"email":88},{"type":128,"investigatorFullName":157,"investigatorTitle":158,"investigatorAffiliation":5,"oldNameTitle":88,"oldOrganization":88},"Kozlov Valentin Sergeevich","Anesthesiologist, Department of Anesthesiology and Intensive Care",[160],{"name":131,"class":121},"100658649","goal-directed-temperature-management-during-prolonged-abdominal-surgery-100658649",false,"NCT07854704","Goal-Directed Temperature Management During Prolonged Abdominal Surgery","Goal-Directed Temperature Management During Prolonged Abdominal Interventions: A Randomized Prospective Pilot Study","Inclusion Criteria:\n\n* Signed written informed consent\n* Age 18 years or older\n* Scheduled abdominal surgery with an expected duration of at least 3 hours\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* End-stage chronic somatic disease\n* Axillary temperature above 37.0 °C before surgery\n* Documented thermoregulatory disorder of any origin, including disorders due to ongoing infectious or autoimmune disease or traumatic brain injury\n* Chronic heart failure stage 2 according to the classification of the Russian Society of Cardiology\n* Active infection before surgery","ALL","18 Years",{"count":171,"type":172},61,"ESTIMATED","INTERVENTIONAL",[175],"NA","During long operations on the abdomen, patients often get cold. Doctors call this perioperative hypothermia. Even a small drop in body temperature can cause problems, such as more bleeding, wound infection, and a longer stay in hospital.\n\nTo keep patients warm during surgery, doctors usually blow warm air over the body through a special blanket. However, the fluids that patients receive through a vein during surgery are normally at room temperature. These cool fluids may lower the body temperature from the inside.\n\nThis study compares two ways of keeping patients warm during operations on the abdomen that last three hours or longer.\n\nEveryone taking part receives warm air blown over the body. In addition, one group receives fluids into a vein at room temperature, about 23 °C, which is the usual practice. The other group receives the same fluids warmed to 39 °C by a special device just before the fluid enters the vein.\n\nParticipants are placed into one of the two groups by chance, like flipping a coin. Because of the nature of the treatment, the doctors caring for the patient know which group the patient is in.\n\nThe researchers measure body temperature before, during, and at the end of surgery. They also record blood pressure, the medicines used to support blood pressure, the amount of fluid given, the amount of urine produced, and blood tests taken on the day after surgery.\n\nThis is a pilot study. Its main purpose is to find out whether a larger study would be possible. The researchers want to learn how many patients can be enrolled, whether the treatment can be given exactly as planned, and how complete the collected information is. The results will be used to plan a larger study.",[178,179,180,181],"Hypothermia Following Anesthesia","Intraoperative Complications","Body Temperature Changes","Anesthesia, General",[183,184,185,186,187,188,189,190,191],"perioperative hypothermia","inadvertent perioperative hypothermia","goal-directed temperature management","intravenous fluid warming","forced-air warming","normothermia","abdominal surgery","pilot study","feasibility study","2026-10-01",{"date":194,"type":195},"2026-10-02","ACTUAL",{"date":197,"type":195},"2024-11-15",{"date":199,"type":172},"2027-06-15",{"name":5,"class":6},1]