Standard Operating Procedures in Daily Clinical Routine

Blood Glucose Clinical Trial

Official title:

Does Implementation of a Standard Operating Procedure for Blood Sugar Control Into Daily Clinical Routine Improve Care of Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00596128
• Other study ID #: UK-SH_Hanss_2008/01
• Status: Completed
• Phase: N/A
• First received: January 7, 2008
• Last updated: June 4, 2008
• Start date: December 2006
• Est. completion date: April 2008

Study information

• Verified date: June 2008
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Primary study endpoint: blood sugar values

Patients: Patients admitted to an ICU

5 steps:

1. Routine treatment,

2. Implementation of SOP for blood sugar monitoring and intervention,

3. Education of intensive care nurses,

4. 6 months free interval without further education or check-up of SOP implementation,

5. Check of SOP implementation and clinical outcome concerning range of blood sugar

Description:

SOP for blood glucose monitoring and treatment was implemented on an intensive care unit. Staff was trained. After a free interval patient's outcome was monitored in terms of daily blood sugar profile prior implementation of SOP and after implementation+free interval of SOP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients admitted to an ICU

Exclusion Criteria:

• Patient's or close relative's refusal

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Glucose

Intervention

Behavioral:
• Implementation of SOP
SOP for blood sugar monitoring and intervention will be defined and ICU nurses will be educated to use this SOP in clinical routine

Locations

Country	Name	City	State
Germany	Department of Anaesthesiology and Intensive Care Medicine, UK S-H Campus Kiel	Kiel	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood sugar range		4 times a day for total ICU stay	No
Secondary	ICU length of stay		After discharge from ICU	No