NCT00596128

Brief Summary

Primary study endpoint: blood sugar values Patients: Patients admitted to an ICU 5 steps:

  1. 1.Routine treatment,
  2. 2.Implementation of SOP for blood sugar monitoring and intervention,
  3. 3.Education of intensive care nurses,
  4. 4.6 months free interval without further education or check-up of SOP implementation,
  5. 5.Check of SOP implementation and clinical outcome concerning range of blood sugar

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

June 5, 2008

Status Verified

June 1, 2008

Enrollment Period

1.3 years

First QC Date

January 7, 2008

Last Update Submit

June 4, 2008

Conditions

Blood Glucose

Keywords

Blood glucoseClinical pathways

Outcome Measures

Primary Outcomes (1)

  • blood sugar range

    4 times a day for total ICU stay

Secondary Outcomes (1)

  • ICU length of stay

    After discharge from ICU

Study Arms (2)

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

Implementation of SOPBEHAVIORAL

SOP for blood sugar monitoring and intervention will be defined and ICU nurses will be educated to use this SOP in clinical routine

Also known as: Insulin
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted to an ICU

You may not qualify if:

  • Patient's or close relative's refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology and Intensive Care Medicine, UK S-H Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Location

MeSH Terms

Interventions

Insulin

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • jens Scholz, MD, Chair

    Department of Anaesthesiology and Intensive Care Medicine, UK S-H Campus Kiel, kiel, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 7, 2008

First Posted

January 16, 2008

Study Start

December 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

June 5, 2008

Record last verified: 2008-06

Locations

DE(1)