Goal-Directed Temperature Management During Prolonged Abdominal Surgery

October 1, 2026 updated by: Kozlov Valentin Sergeevich, The Leningrad Regional Clinical Hospital

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Russia
      • Saint Petersburg, Russia, 194291
        • Recruiting
        • The Leningrad Regional Clinical Hospital
        • Contact:
        • Sub-Investigator:
          • Alexey S Rumyantsev-Aleksandrov, MD
        • Principal Investigator:
          • Valentin S Kozlov, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed written informed consent
  • Age 18 years or older
  • Scheduled abdominal surgery with an expected duration of at least 3 hours

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control group

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.
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.

Other Names:
  • WarmTouch WT-5900
Other: Unwarmed intravenous fluids

Balanced crystalloid solutions stored at an ambient temperature of 23 °C and administered intravenously without additional warming.
Experimental: Study group

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.
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.

Other Names:
  • WarmTouch WT-5900
Device: 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.

Other Names:
  • IRIS medical fluid warmer

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At transfer to the intensive care unit, up to 12 hours after skin incision

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perioperative axillary temperature
Time Frame: Before induction of anaesthesia, hourly during surgery, and at admission to the intensive care unit, up to 12 hours

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
Perioperative oesophageal temperature
Time Frame: Hourly from 1 hour after start of surgery until admission to the intensive care unit, up to 12 hours

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
Proportion of participants requiring norepinephrine infusion
Time Frame: Intraoperative period, up to 12 hours

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
Time from skin incision to initiation of norepinephrine infusion
Time Frame: Intraoperative period, up to 12 hours

Interval between skin incision and the start of norepinephrine infusion, assessed only in participants who received norepinephrine. Measured in minutes.
Intraoperative period, up to 12 hours
Norepinephrine infusion rate
Time Frame: Intraoperative period, up to 12 hours

Rate of intraoperative norepinephrine infusion, assessed only in participants who received norepinephrine. Measured in micrograms per kilogram per minute.
Intraoperative period, up to 12 hours
Volume of intraoperative crystalloid infusion
Time Frame: From skin incision to end of surgery, up to 12 hours

Total volume of balanced crystalloid solutions administered intravenously during surgery. Measured in millilitres.
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

Total volume of urine collected during surgery. Measured in millilitres.
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

Stroke volume assessed non-invasively by tetrapolar impedance rheography. Measured in millilitres.
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

Cardiac output assessed non-invasively by tetrapolar impedance rheography. Measured in litres per minute.
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

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
Base excess in venous blood
Time Frame: Postoperative day 1

Base excess determined by venous blood gas analysis. Measured in millimoles per litre.
Postoperative day 1
Plasma lactate concentration
Time Frame: Postoperative day 1

Lactate concentration determined in venous blood. Measured in millimoles per litre.
Postoperative day 1
Serum C-reactive protein concentration
Time Frame: Postoperative day 1

C-reactive protein concentration determined in venous blood. Measured in milligrams per litre.
Postoperative day 1
Total SOFA score
Time Frame: Postoperative day 1

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.
Postoperative day 1

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of screened participants who were randomised
Time Frame: From start of enrolment through study completion, up to 32 months

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
Proportion of eligible participants who provided informed consent
Time Frame: From start of enrolment through study completion, up to 32 months

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.
From start of enrolment through study completion, up to 32 months
Recruitment rate
Time Frame: From start of enrolment through study completion, up to 32 months

Feasibility outcome. Number of randomised participants per month of enrolment.
From start of enrolment through study completion, up to 32 months
Adherence to the allocated intervention
Time Frame: From start of enrolment through study completion, up to 32 months

Feasibility outcome. Number of randomised participants who received the allocated intervention in full, divided by the number of randomised participants, expressed as a percentage.
From start of enrolment through study completion, up to 32 months
Proportion of randomised participants with analysable data
Time Frame: From start of enrolment through study completion, up to 32 months

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.
From start of enrolment through study completion, up to 32 months
Completeness of data for the primary outcome measure
Time Frame: From start of enrolment through study completion, up to 32 months

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.
From start of enrolment through study completion, up to 32 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Leningrad Regional Clinical Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
North-Western State Medical University named after I.I.Mechnikov

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Valentin S Kozlov, MD, The Leningrad Regional Clinical Hospital
  • Principal Investigator: Ionas S Simutis, MD, Dsc, North-Western State Medical University named after I.I.Mechnikov

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LOKB-TTM-2024-01
  • Protocol N. 9 dated 23.10.2024 (Other Identifier: Local Ethics Committee, North-Western State Medical University named after I.I. Mechnikov)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Beginning 6 months after publication of the main results and ending 3 years thereafter.

IPD Sharing Access Criteria

Requests should be directed to the corresponding author and will be evaluated on the basis of scientific merit. Data will be shared after approval of a proposal and completion of a data access agreement.

Study Data/Documents

  1. Study Protocol
    Information identifier: OSF.IO/4GCFX
    Information comments:

    Study protocol summary, version 1.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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