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Comparison of Three Protocols for Tight Glycemic Control in Cardiac Surgery Patients

Comparison of Three Protocols for Tight Glycemic Control in Cardiac Surgery Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00764712
Enrollment
120
Registered
2008-10-02
Start date
2008-02-29
Completion date
2008-04-30
Last updated
2012-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycemia

Keywords

Tight glycemia control, cardiac surgery patients

Brief summary

A randomized trial to compare three insulin-titration protocols for tight glycemic control in surgical ICU: an absolute glucose (Matias) protocol, a relative glucose change (Bath) protocol, and an enhanced model predictive control algorithm (eMPC)

Detailed description

120 consecutive post-cardiac surgery patients randomized to the three protocols with a target glycemia range from 4.4 to 6.1 mmol/l. Intravenous insulin was administered continuously or in combination with insulin boluses (Matias protocol). Blood glucose was measured in 1-4 hour intervals as requested by protocols.

Interventions

DRUGinsulin

Insulin was was administered according to each protocol rules/suggestions into a central venous line as a continuous infusion (Bath and eMPC protocols) or as a combination of a continuous infusion and boluses (Matias protocol). A standard concentration of 50 IU of insulin in 50 ml of 0.9% NaCl was used. In all patients, infusion of 10% glucose solution was initiated upon admission to ICU with glucose dose of 2.5 g/kg of ideal body weight (height in centimetres minus 100) per hour and lasted for 18 hours, when normal oral food intake was started. In ventilated patients, the glucose infusion lasted for 48 hours, and then standard enteral nutrition was initiated.

Sponsors

Charles University, Czech Republic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* patients admitted to the postoperative ICU after elective cardiac surgery

Exclusion criteria

* insulin allergy

Design outcomes

Primary

MeasureTime frame
The effectiveness of different TGC management protocolsICU stay

Secondary

MeasureTime frame
The safety with respect to hypoglycemiaICU stay

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026