Accuracy and feasibility of real-time continuous glucose monitoring in early postoperative intensive care after liver transplantation.
Marek Protus, Barbora Voglová Hagerf, Antonin Jabor...
https://pubmed.ncbi.nlm.nih.gov/41523586Actively Recruiting
Led by Institute for Clinical and Experimental Medicine · Updated on 2024-03-05
500
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are evaluating the use of continuous glucose monitors (CGM) in patients in intensive care units (ICU) who have undergone major surgeries such as pancreas surgery, liver transplantation, or simultaneous pancreas and kidney transplantation, including those with diabetes mellitus. The study aims to determine if CGM helps maintain blood glucose within the recommended target range and to compare the accuracy of CGM sensors with standard blood glucose measurement methods. This non-commercial, randomized, open-label study is conducted to address the challenges of glucose control in ICU patients and reduce the burden on nursing staff. Participants will be randomized into two groups: one group will use an active CGM device (Dexcom G6) to guide insulin therapy, while the control group will receive standard care with blinded CGM monitoring without influencing treatment. Continuous glucose monitoring begins after surgery to avoid interference during procedures, and insulin doses will be adjusted according to the standard ICU protocol. Each surgical patient group will be randomized and analyzed independently. During the approximately 5 to 7 days in the postoperative ICU, participants will have their glucose levels continuously monitored and insulin doses recorded. Researchers will measure the time spent in the target glucose range, episodes of high or low blood sugar, glycemic variability, surgical and infectious complications, and duration of hospital stay. Blood glucose will also be measured using standard biochemistry methods. This comprehensive monitoring aims to compare the performance and benefits of CGM in maintaining glucose control during critical postoperative care.
CONDITIONS
Continuous Glucose Monitoring in Intensive Care Unit
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day plus approximately 5 to 7 days in postoperative ICU
Participants undergo the planned major surgery. Continuous glucose monitoring is initiated after surgery upon admission to the postoperative ICU.
Continuous monitoring during ICU stay
Duration - Approximately 10 to 15 days from ICU admission until hospital discharge
Participants are monitored for surgical and infectious complications and overall recovery until hospital discharge.
Follow-up visits during hospital stay
Total: 1 location
1
Institute for Clinical and Experimental Medicine
Prague, Czechia
Actively Recruiting
B
Barbora Hagerf, MD
M
Marek Protuš, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Marek Protus, Barbora Voglová Hagerf, Antonin Jabor...
https://pubmed.ncbi.nlm.nih.gov/41523586