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Standard Operating Procedures in Daily Clinical Routine

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ClinicalTrials.gov Identifier: NCT00596128
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : June 5, 2008
Sponsor:
Information provided by:
University of Schleswig-Holstein

Brief 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

Condition or disease Intervention/treatment Phase
Blood Glucose Behavioral: Implementation of SOP Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 800 participants
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
Study Start Date : December 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. blood sugar range [ Time Frame: 4 times a day for total ICU stay ]

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


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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

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

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 Posted: January 16, 2008    Key Record Dates
Last Update Posted: June 5, 2008
Last Verified: June 2008

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