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Standard Operating Procedures in Daily Clinical Routine

This study has been completed.
Sponsor:
Information provided by:
University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT00596128
First received: January 7, 2008
Last updated: June 4, 2008
Last verified: June 2008
History of Changes
  Purpose

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

Condition Intervention
Blood Glucose
 Behavioral: Implementation of SOP

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does Implementation of a Standard Operating Procedure for Blood Sugar Control Into Daily Clinical Routine Improve Care of Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • blood sugar range [ Time Frame: 4 times a day for total ICU stay ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ICU length of stay [ Time Frame: After discharge from ICU ] [ Designated as safety issue: No ]

Enrollment: 800
Study Start Date: December 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Blood sugar monitoring and intervention as clinical routine, no SOP defined and implemented
Experimental: 2
Blood sugar monitoring after implementation of SOP
 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
Other Name: Insulin

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients admitted to an ICU

Exclusion Criteria:

  • Patient's or close relative's refusal
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00596128

Locations
Germany
Department of Anaesthesiology and Intensive Care Medicine, UK S-H Campus Kiel
Kiel, Schleswig-Holstein, Germany, 24105
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
Principal Investigator: jens Scholz, MD, Chair Department of Anaesthesiology and Intensive Care Medicine, UK S-H Campus Kiel, kiel, Germany
  More Information

No publications provided

Responsible Party: Jens Scholz, Department of Anaesthesiology, UK S-H Campus Kiel
ClinicalTrials.gov Identifier: NCT00596128     History of Changes
Other Study ID Numbers: UK-SH_Hanss_2008/01
Study First Received: January 7, 2008
Last Updated: June 4, 2008
Health Authority: Germany: Ethics Commission

Keywords provided by University of Schleswig-Holstein:
Blood glucose
Clinical pathways

ClinicalTrials.gov processed this record on June 17, 2013