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RECRUITING
NCT07854704
NA

Goal-Directed Temperature Management During Prolonged Abdominal Surgery

Sponsor: The Leningrad Regional Clinical Hospital

View on ClinicalTrials.gov

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.

Official title: Goal-Directed Temperature Management During Prolonged Abdominal Interventions: A Randomized Prospective Pilot Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

61

Start Date

2024-11-15

Completion Date

2027-06-15

Last Updated

2026-10-02

Healthy Volunteers

No

Interventions

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.

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

Unwarmed intravenous fluids

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

Locations (1)

The Leningrad Regional Clinical Hospital

Saint Petersburg, Russia