Hypothermia Following AnesthesiaNCT07854704
Goal-Directed Temperature Management During Prolonged Abdominal Surgery
A study testing Forced-air warming, Intravenous fluid warming and Unwarmed intravenous fluids in people with Hypothermia Following Anesthesia and Intraoperative Complications, run by The Leningrad Regional Clinical Hospital at 1 site in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypothermia Following Anesthesia, Intraoperative Complications, Body Temperature Changes
- What is being tested?
- Forced-air warming, Intravenous fluid warming and Unwarmed intravenous fluids
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteRussia
- Study dates
- 15 Nov 2024to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- Age 18 years or older
- Scheduled abdominal surgery with an expected duration of at least 3 hours
Who cannot join
- Pregnancy or breastfeeding
- End-stage chronic somatic disease
- Axillary temperature above 37.0 °C before surgery
- Documented thermoregulatory disorder of any origin, including disorders due to ongoing infectious or autoimmune disease or traumatic brain injury
- Chronic heart failure stage 2 according to the classification of the Russian Society of Cardiology
- Active infection before surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
The Leningrad Regional Clinical Hospital
Saint Petersburg, 194291
Valentin S Kozlov, MD, +7-931-250-79-30, kozlov.vs@47lokb.ru
Alexey S Rumyantsev-Aleksandrov, MD
About this study
Official title: Goal-Directed Temperature Management During Prolonged Abdominal Interventions: A Randomized Prospective Pilot Study
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.
To 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.
Read more
This study compares two ways of keeping patients warm during operations on the abdomen that last three hours or longer.
Everyone 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.
Participants 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.
The 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.
This 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.
Read the detailed description
Design and setting.
Single-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.
Anaesthesia and warming protocol.
All 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.
Measurements.
Axillary 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.
Randomisation and allocation concealment.
The 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.
Withdrawal criteria.
Participants 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.
Feasibility assessment.
In 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.
- Conditions
- Hypothermia Following Anesthesia, Intraoperative Complications, Body Temperature Changes, Anesthesia, General
- Being tested
- Forced-air warming, Intravenous fluid warming, Unwarmed intravenous fluids
- Keywords
- perioperative hypothermia, inadvertent perioperative hypothermia, goal-directed temperature management, intravenous fluid warming, forced-air warming, normothermia, abdominal surgery, pilot study, feasibility study
- Medical subject headings
- Intraoperative Complications, Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forced-air warmingDevice
Also called WarmTouch WT-5900
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.
Intravenous fluid warmingDevice
Also called IRIS medical fluid warmer
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.
Unwarmed intravenous fluidsOther
Balanced crystalloid solutions stored at an ambient temperature of 23 °C and administered intravenously without additional warming.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Forced-air warming; Other: Unwarmed intravenous fluids |
| 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. Receives: Device: Forced-air warming; Device: Intravenous fluid warming |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At transfer to the intensive care unit, up to 12 hours after skin incision
Secondary outcomes (14)
Perioperative axillary temperature
Axillary temperature measured with a contact thermometer. Measured in degrees Celsius.
Measured: Before induction of anaesthesia, hourly during surgery, and at admission to the intensive care unit, up to 12 hours
Perioperative oesophageal temperature
Core temperature measured with an oesophageal probe. Measured in degrees Celsius.
Measured: Hourly from 1 hour after start of surgery until admission to the intensive care unit, up to 12 hours
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.
Measured: Intraoperative period, up to 12 hours
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.
Measured: Intraoperative period, up to 12 hours
Norepinephrine infusion rate
Rate of intraoperative norepinephrine infusion, assessed only in participants who received norepinephrine. Measured in micrograms per kilogram per minute.
Measured: Intraoperative period, up to 12 hours
Volume of intraoperative crystalloid infusion
Total volume of balanced crystalloid solutions administered intravenously during surgery. Measured in millilitres.
Measured: From skin incision to end of surgery, up to 12 hours
Intraoperative urine output
Total volume of urine collected during surgery. Measured in millilitres.
Measured: From skin incision to end of surgery, up to 12 hours
Stroke volume measured by tetrapolar impedance rheography
Stroke volume assessed non-invasively by tetrapolar impedance rheography. Measured in millilitres.
Measured: From before induction of anaesthesia, hourly during surgery, up to 12 hours
Cardiac output measured by tetrapolar impedance rheography
Cardiac output assessed non-invasively by tetrapolar impedance rheography. Measured in litres per minute.
Measured: From before induction of anaesthesia, hourly during surgery, up to 12 hours
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.
Measured: From start of surgery to end of surgery, up to 12 hours
Base excess in venous blood
Base excess determined by venous blood gas analysis. Measured in millimoles per litre.
Measured: Postoperative day 1
Plasma lactate concentration
Lactate concentration determined in venous blood. Measured in millimoles per litre.
Measured: Postoperative day 1
Serum C-reactive protein concentration
C-reactive protein concentration determined in venous blood. Measured in milligrams per litre.
Measured: Postoperative day 1
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.
Measured: Postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start15 Nov 2024
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothermia Following AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups; all participants receive forced-air warming, with the study group additionally receiving actively warmed intravenous fluids.
- Masking
- None (open label)
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leningrad Regional Clinical Hospital
- Sponsor type
- Other government
- Collaborators
- North-Western State Medical University named after I.I.Mechnikov
- Responsible party
- Principal investigator, Kozlov Valentin Sergeevich, The Leningrad Regional Clinical Hospital
- Investigators
- Valentin S Kozlov, MD, Principal investigator, The Leningrad Regional Clinical HospitalIonas S Simutis, MD, Dsc, Principal investigator, North-Western State Medical University named after I.I.Mechnikov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854704
- Sponsor's protocol ID
- LOKB-TTM-2024-01
- Other IDs
- Protocol N. 9 dated 23.10.2024
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results will be made available to qualified researchers upon reasonable request to the corresponding author, following approval of a methodologically sound proposal.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal-Directed Temperature Management During Prolonged Abdominal Interventions: A Randomized Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT07854704
- Acronym / sponsor ID
- LOKB-TTM-2024-01
- Conditions
- Hypothermia Following Anesthesia, Intraoperative Complications, Body Temperature Changes, Anesthesia, General
- Keywords
- perioperative hypothermia, inadvertent perioperative hypothermia, goal-directed temperature management, intravenous fluid warming, forced-air warming, normothermia, abdominal surgery, pilot study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- The Leningrad Regional Clinical HospitalOther government
- Collaborators
- North-Western State Medical University named after I.I.Mechnikov
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
To 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.
This study compares two ways of keeping patients warm during operations on the abdomen that last three hours or longer.
Everyone 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.
Participants 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.
The 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.
This 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.
Detailed description
Design and setting.
Single-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.
Anaesthesia and warming protocol.
All 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.
Measurements.
Axillary 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.
Randomisation and allocation concealment.
The 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.
Withdrawal criteria.
Participants 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.
Feasibility assessment.
In 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two parallel groups; all participants receive forced-air warming, with the study group additionally receiving actively warmed intravenous fluids.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Device: Forced-air warming, Other: Unwarmed intravenous fluidsForced-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. |
| Study group | Experimental | Device: Forced-air warming, Device: Intravenous fluid warmingForced-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed written informed consent
- Age 18 years or older
- Scheduled abdominal surgery with an expected duration of at least 3 hours
Key exclusion criteria (6 listed)
- Pregnancy or breastfeeding
- End-stage chronic somatic disease
- Axillary temperature above 37.0 °C before surgery
- Documented thermoregulatory disorder of any origin, including disorders due to ongoing infectious or autoimmune disease or traumatic brain injury
- Chronic heart failure stage 2 according to the classification of the Russian Society of Cardiology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forced-air warmingAlso: WarmTouch WT-5900Forced-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. | Device | Control group, Study group |
| Intravenous fluid warmingAlso: IRIS medical fluid warmerBalanced 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. | Device | Study group |
| Unwarmed intravenous fluidsBalanced crystalloid solutions stored at an ambient temperature of 23 °C and administered intravenously without additional warming. | Other | Control group |
Primary outcome
Core body temperature at admission to the intensive care unit
Time frame: At transfer to the intensive care unit, up to 12 hours after skin incision
Oesophageal temperature measured at the time of transfer of the participant from the operating room to the intensive care unit, in degrees Celsius.
14 secondary outcomes
Perioperative axillary temperature
Time frame: Before induction of anaesthesia, hourly during surgery, and at admission to the intensive care unit, up to 12 hours
Perioperative oesophageal temperature
Time frame: Hourly from 1 hour after start of surgery until admission to the intensive care unit, up to 12 hours
Proportion of participants requiring norepinephrine infusion
Time frame: Intraoperative period, up to 12 hours
Time from skin incision to initiation of norepinephrine infusion
Time frame: Intraoperative period, up to 12 hours
Norepinephrine infusion rate
Time frame: Intraoperative period, up to 12 hours
Volume of intraoperative crystalloid infusion
Time frame: From skin incision to end of surgery, up to 12 hours
Intraoperative urine output
Time frame: From skin incision to end of surgery, up to 12 hours
Stroke volume measured by tetrapolar impedance rheography
Time frame: From before induction of anaesthesia, hourly during surgery, up to 12 hours
Cardiac output measured by tetrapolar impedance rheography
Time frame: From before induction of anaesthesia, hourly during surgery, up to 12 hours
Change in extracellular fluid volume measured by tetrapolar impedance rheography
Time frame: From start of surgery to end of surgery, up to 12 hours
Base excess in venous blood
Time frame: Postoperative day 1
Plasma lactate concentration
Time frame: Postoperative day 1
Serum C-reactive protein concentration
Time frame: Postoperative day 1
Total SOFA score
Time frame: Postoperative day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results will be made available to qualified researchers upon reasonable request to the corresponding author, following approval of a methodologically sound proposal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valentin S Kozlov, MD principal investigator
The Leningrad Regional Clinical Hospital
Ionas S Simutis, MD, Dsc principal investigator
North-Western State Medical University named after I.I.Mechnikov
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forced-air warming, Intravenous fluid warming and Unwarmed intravenous fluids in people with Hypothermia Following Anesthesia and Intraoperative Complications, run by The Leningrad Regional Clinical Hospital at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valentin S Kozlov, MD (+7-931-250-79-30, kozlov.vs@47lokb.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core body temperature at admission to the intensive care unit (time frame: At transfer to the intensive care unit, up to 12 hours after skin incision). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.