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

Charles University, Czech Republic

Status: Completed

Conditions: Hyperglycemia

Treatments: Drug: insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT00764712

POINT-protocols

GAUK no. 44407

Details and patient eligibility

About

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)

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients admitted to the postoperative ICU after elective cardiac surgery

Exclusion criteria

• insulin allergy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Matias protocol

Active Comparator group

Description:

A protocol based on the absolute glucose value - Matias protocol (Matias)

Treatment:

Drug: insulin

Bath protocol

Active Comparator group

Description:

A protocol based on the relative glucose change - Bath protocol (Bath)

Treatment:

Drug: insulin

eMPC

Active Comparator group

Description:

a computer-based model predictive control algorithm with variable sampling rate (eMPC)

Treatment:

Drug: insulin