Standard Operating Procedures in Daily Clinical Routine

June 4, 2008 updated by: University Hospital Schleswig-Holstein

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Department of Anaesthesiology and Intensive Care Medicine, UK S-H Campus Kiel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients admitted to an ICU

Exclusion Criteria:

  • Patient's or close relative's refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Insulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
blood sugar range
Time Frame: 4 times a day for total ICU stay
4 times a day for total ICU stay

Secondary Outcome Measures

Outcome Measure
Time Frame
ICU length of stay
Time Frame: After discharge from ICU
After discharge from ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Schleswig-Holstein

Investigators

  • Principal Investigator: jens Scholz, MD, Chair, Department of Anaesthesiology and Intensive Care Medicine, UK S-H Campus Kiel, kiel, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

January 7, 2008

First Submitted That Met QC Criteria

January 15, 2008

First Posted (Estimate)

January 16, 2008

Study Record Updates

Last Update Posted (Estimate)

June 5, 2008

Last Update Submitted That Met QC Criteria

June 4, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UK-SH_Hanss_2008/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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