Standard Operating Procedures in Daily Clinical Routine | NCT00596128

Studies
Standard Operating Procedures in Daily Clinical Routine

NCT00596128

Sponsor

University Hospital Schleswig-Holstein

Status

Completed

Last Update Posted

Jun 5, 2008Estimated

Enrollment

800Actual

Phase

Not Applicable

Conditions

Blood Glucose

Interventions

Implementation of SOP

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Apr 2008Actual

Completion Date

Apr 2008Actual

First Submitted Date

Jan 7, 2008

First Submission Date that Met QC Criteria

Jan 15, 2008

First Posted Date

Jan 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2008

Last Update Posted Date

Jun 5, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

800Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Behavioral: Implementation of SOP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Implementation of SOP	Behavioral	SOP for blood sugar monitoring and intervention will be defined and ICU nurses will be educated to use this SOP in clinical routine	2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
ICU length of stay		After discharge from ICU

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients admitted to an ICU

Exclusion Criteria:

Patient's or close relative's refusal

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anaesthesiology and Intensive Care Medicine, UK S-H Campus Kiel		Kiel	Schleswig-Holstein	24105	Germany

Intervention Browse Module

MeSH Terms

ID	Term
D007328	Insulin

Ancestor Terms

ID	Term
D011384	Proinsulin
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones

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