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Standard Operating Procedures in Daily Clinical Routine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00596128
First Posted: January 16, 2008
Last Update Posted: June 5, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Schleswig-Holstein
  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: Intervention Model: Single Group Assignment
Masking: None (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:


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 ]

Secondary Outcome Measures:
  • ICU length of stay [ Time Frame: After discharge from ICU ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients admitted to an ICU

Exclusion Criteria:

  • Patient's or close relative's refusal
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 7, 2008
First Posted: January 16, 2008
Last Update Posted: June 5, 2008
Last Verified: June 2008

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