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NCT07854704
Goal-Directed Temperature Management During Prolonged Abdominal Surgery
Conditions: Hypothermia Following Anesthesia, Intraoperative Complications, Body Temperature Changes, Anesthesia, General
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 61
Sponsor: The Leningrad Regional Clinical Hospital
Location: The Leningrad Regional Clinical Hospital Saint Petersburg
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.
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07854704). StuddyBuddy aggregates publicly available trial information.