Recognition and Treatment of Dysglycemia. AGS - Acute Glucose Service (AGS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Arthroplasty Complications; Dysglycemia
• Intervention / Treatment: Other: AG service

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marianne Ylikoski, MD; Phone Number: +358447195268; Email: marianne.ylikoski@phhyky.fi
• Study Contact Backup: Name: Raine Tiihonen, MD, PhD; Phone Number: +358444406151; Email: raine.tiihonen@phhyky.fi

Study Locations

• Finland
  • Lahti, Finland, 15850
    • Recruiting
    • Päijät-Häme Central hospital
    • Contact: Marianne Ylikoski, MD; Phone Number: +358447195268; Email: marianne.ylikoski@phhyky.fi
    • Contact: Raine Tiihonen, MD, PhD; Phone Number: +3584406151; Email: raine.tiihonen@phhyky.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AG service; In the "Active Comparator Arm": Screening, follow-up and treatment of dysglycemias in the elective orthopedic prosthetic surgery (knee / hip) patients in the Päijät-Häme Central hospital will be optimized and individualized in the patients in personal manner.	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.
No Intervention: Without AG service; In the "No intervention Arm": Screening, follow-up and treatment of dysglycemias in the elective orthopedic prosthetic surgery (knee / hip) patients follows the current protocol of Päijät-Häme Central hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Improved survival	1-5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Less complications after AG-service	1-5 years

Collaborators and Investigators

• Sponsor: Joint Authority for Päijät-Häme Social and Health Care
• Investigators: Principal Investigator: Marianne Ylikoski, MD, Päijät-Häme Central hospital

Publications and helpful links

General Publications

• Ylikoski M, Jokinen JJ, Lahtela J, Kauppi MJ, Huhtala H, Immonen H, Tiihonen R. Perioperative hyperglycaemia in elective arthroplasties. Should we do better? Acta Anaesthesiol Scand. 2020 Oct;64(9):1253-1261. doi: 10.1111/aas.13666. Epub 2020 Jul 30.

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2017
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: September 19, 2017
• First Submitted That Met QC Criteria: October 10, 2017
• First Posted (Actual): October 11, 2017

Study Record Updates

• Last Update Posted (Actual): October 11, 2017
• Last Update Submitted That Met QC Criteria: October 10, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Hospital; Perioperative complications; Dysglycemia management team; Nurse Practitioner
• Other Study ID Numbers: Q321dnro 47/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No