Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID05585801

Continuous Glucose Monitoring in Intensive Care Unit to Evaluate Glucose Control After Major Surgery

Led by Institute for Clinical and Experimental Medicine · Updated on 2024-03-05

500

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

Continuous Glucose Monitoring in Intensive Care Unit

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients aged 18 to 80 years
  • Undergoing pancreas surgery (total or partial resection), orthotopic liver transplantation, simultaneous pancreas and kidney transplantation, or major surgery with diabetes mellitus
  • Receiving postoperative care in ICU
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Any condition that prevents the surgical procedures involved

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

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

Post-operative Follow-up

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

Trial Site Locations

Total: 1 location

1

Institute for Clinical and Experimental Medicine

Prague, Czechia

Actively Recruiting

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Research Team

B

Barbora Hagerf, MD

M

Marek Protuš, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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/41523586