Recognition and Treatment of Dysglycemia. AGS - Acute Glucose Service

Arthroplasty Complications Clinical Trial

— AGS  

Official title:

Recognition and Treatment of Dysglycemia in Elective Knee and Hip Arthroplasties. AGS - Acute Glucose Service

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03306810
• Other study ID #: Q321dnro 47/17
• Status: Recruiting
• Phase: N/A
• First received: September 19, 2017
• Last updated: October 10, 2017
• Start date: September 26, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2017
• Source: Joint Authority for Päijät-Häme Social and Health Care
• Contact: Marianne Ylikoski, MD
• Phone: +358447195268
• Email: marianne.ylikoski[@]phhyky.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

AGS (Acute Glucose Service ) is an inpatient glucose management service consisting of Nurse Practitioner and physician. Team manages not - consulted- based preoperative assessment, perioperative glucose control, patient education and supervision, but also transition of care postoperatively. The goal is to detect and treat dysglycemias , but also provide an active and constantly ongoing education to other hospital teams.

AGS improves better overall- survival of arthroplastic patients and is an effective way to recognize and treat dysglycemias and to organize constantly ongoing education.

Description:

600 elective knee and hip arthroplastic patients are collected. 200 patients before AG- service will be compared to 400 patients after AGS. The latter group is divided to two 200 patients groups: 1) with AGS 2) with AGS extended to first control in 3 months (AG- nurse may be contacted by phone). Patients are followed up up to 5 years. Controls will be held after 3 months, 1 year and 5 years after operation including B-Hba1c, 15 D Quality of life assessment and patient interview.

There are several aims of the team and study: to detect, diagnose and optimize treatment (including medication) of diabetic/ dysglycemic patients from preoperative assessment 1 week before operation to postoperative care. With blood glucose target 42 - 86 mmol/mol results better overall survival, lesser complications (i.e. infections, cardiovascular or renal complications) and shorter length of hospital stay. Other aim is to find undiagnosed diabetics or those at risk of developing diabetes. One aim is to find risk factors, which lead to stress hyperglycemia during perioperative period or diabetes in 5 years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged > 18 years

• Elective knee and hip arthroplasty patients

Exclusion Criteria:

• Patients who are incompetent to give informed consent

• Patients who are incompetent to assess their Quality-of-Life personally

Related Conditions & MeSH terms

• Arthroplasty Complications
• Dysglycemia

Intervention

Other:
• AG service
The AG service group is divided to two 200 patients groups: 1) with AGS 2) with AGS extended to first control in 3 months (AG- nurse may be contacted by phone). Patients are followed up up to 5 years.

Locations

Country	Name	City	State
Finland	Päijät-Häme Central Hospital	Lahti

Sponsors (1)

Lead Sponsor	Collaborator
Joint Authority for Päijät-Häme Social and Health Care

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Improved survival	1-5 years
Secondary	Complications	Less complications after AG-service	1-5 years