Blood GlucoseNCT00596128
Standard Operating Procedures in Daily Clinical Routine
A study testing Implementation of SOP in people with Blood Glucose, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Glucose
- What is being tested?
- Implementation of SOP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2006to Apr 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to an ICU
Who cannot join
- Patient's or close relative's refusal
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anaesthesiology and Intensive Care Medicine, UK S-H Campus Kiel
Kiel, Schleswig-Holstein, 24105
About this study
Official title: 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:
- Routine treatment,
- Implementation of SOP for blood sugar monitoring and intervention,
- Education of intensive care nurses,
- 6 months free interval without further education or check-up of SOP implementation,
- Check of SOP implementation and clinical outcome concerning range of blood sugar
Read the 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.
- Conditions
- Blood Glucose
- Being tested
- Implementation of SOP
- Keywords
- Blood glucose, Clinical pathways
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of SOPBehavioural
Also called Insulin
SOP for blood sugar monitoring and intervention will be defined and ICU nurses will be educated to use this SOP in clinical routine
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Blood sugar monitoring and intervention as clinical routine, no SOP defined and implemented |
| 2 | Experimental | Blood sugar monitoring after implementation of SOP Receives: Behavioral: Implementation of SOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood sugar range
Measured: 4 times a day for total ICU stay
Secondary outcomes (1)
ICU length of stay
Measured: After discharge from ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startDec 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood GlucoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Investigators
- jens Scholz, MD, Chair, Principal investigator, Department of Anaesthesiology and Intensive Care Medicine, UK S-H Campus Kiel, kiel, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596128
- Sponsor's protocol ID
- UK-SH_Hanss_2008/01
- Status last verified
- Jun 2008
- First submitted
- 7 Jan 2008
- Last updated
- 5 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Implementation of a Standard Operating Procedure for Blood Sugar Control Into Daily Clinical Routine Improve Care of Patients
- ClinicalTrials.gov ID
- NCT00596128
- Acronym / sponsor ID
- UK-SH_Hanss_2008/01
- Conditions
- Blood Glucose
- Keywords
- Blood glucose, Clinical pathways
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary study endpoint: blood sugar values
Patients: Patients admitted to an ICU
5 steps:
- Routine treatment,
- Implementation of SOP for blood sugar monitoring and intervention,
- Education of intensive care nurses,
- 6 months free interval without further education or check-up of SOP implementation,
- Check of SOP implementation and clinical outcome concerning range of blood sugar
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Blood sugar monitoring and intervention as clinical routine, no SOP defined and implemented |
| 2 | Experimental | Behavioral: Implementation of SOPBlood sugar monitoring after implementation of SOP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted to an ICU
Key exclusion criteria (1 listed)
- Patient's or close relative's refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation of SOPAlso: InsulinSOP for blood sugar monitoring and intervention will be defined and ICU nurses will be educated to use this SOP in clinical routine | Behavioural | 2 |
Primary outcome
blood sugar range
Time frame: 4 times a day for total ICU stay
1 secondary outcome
ICU length of stay
Time frame: After discharge from ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jens Scholz, MD, Chair principal investigator
Department of Anaesthesiology and Intensive Care Medicine, UK S-H Campus Kiel, kiel, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of SOP in people with Blood Glucose, run by University Hospital Schleswig-Holstein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood sugar range (time frame: 4 times a day for total ICU stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2008; AzTrials last refreshed its copy on 29 Oct 2026.