The primary objective of this study is to investigate the peri-operative accuracy and safety of the RT-CGMS in cardiac surgical patients.The secondary objective is to identify and define possible factors interfering with reliable and adequate…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Correlation between data obtained with the RT-CGMS and the conventional method.
Pairs of data will be analysed using correlation coefficients and Continuous
Glucose Error Grid Analysis.
Adverse effects of the RT-CGMS : irritation of skin, disconnection etc.
Secondary outcome
Degree of glucose control defined as the percent and time of blood glucose
measurements in normoglycaemia, hypoglycaemia and hyperglycaemia, as recorded
both with sensor measurements and ward measurements; insulin dose; frequency of
insulin dose adjustments; time to reach normoglycaemia.
Occurrence of clinical events; hypothermia (Temperature < 36 degrees Celsius),
shock (systolic blood pressure<100 mm Hg), acidosis (pH <7.35), other events
deemed significant in glucose metabolism and its effect on RT-CGMS.
Other study parameters: sex, age, body weight, body height, BMI, history of
diabetes mellitus, presence of risk factors for diabetes mellitus, Severity
score, reasons for ICU admission, use of relevant clinical intervention
(nutrition therapy, corticosteroid, vasopressors, etc)
Background summary
Strict glycemic control improves outcome of patients admitted to the intensive
care (ICU). Real Time Continuous Glucose monitoring System (RT-CGMS) is a novel
system which can provide health care professionals with real time information
about the blood glucose level without the need for multiple invasive
measurements. Furthermore, with continuous monitoring it is possible to
identify trends in glycemic profiles. Its peri-operative accuracy and safety
have never been tested in a population of patients admitted for elictive
cardiac surgery.
Study objective
The primary objective of this study is to investigate the peri-operative
accuracy and safety of the RT-CGMS in cardiac surgical patients.
The secondary objective is to identify and define possible factors interfering
with reliable and adequate glucose measurements and to incestigate its effect
on glucose control.
Study design
Open label, randomized controlled trial
Study burden and risks
The RT-CGMS sensor will be inserted once in the abdominal skin. This sensor can
stay in situ for 3 days. There is a small risk of skin irritation, infection,
haematoma or bleeding involved with the insertion of the sensor.
Because all therapy adjustments will be based on the standard ICU blood glucose
protocol, no greater risk of hypoglycaemia is present in the active group than
in the control group. The amount of extra glucose measurements in the Active
Group will depend on the number of alerts given by the RT-CGMS.
postbus 10400
8000 GK Zwolle
Nederland
postbus 10400
8000 GK Zwolle
Nederland
Listed location countries
Age
Inclusion criteria
scheduled for elective cardiac surgery
age over 18
expected stay in hospital > 3 days
Exclusion criteria
failure to obtain informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL12530.075.06 |