Recognition and Treatment of Dysglycemia. AGS - Acute Glucose Service

NCT ID: NCT03306810

Last Updated: 2017-10-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-26
• Study Completion Date: 2025-12-31

Brief 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.

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.

Conditions

Dysglycemia; Arthroplasty Complications

Keywords

Perioperative complications; Dysglycemia management team; Nurse Practitioner; Hospital

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

AG service

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Joint Authority for Päijät-Häme Social and Health Care

OTHER

Sponsor Role: lead

Responsible Party

Marjo Soini

CRA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marianne Ylikoski, MD

Role: PRINCIPAL_INVESTIGATOR

Päijät Häme Central Hospital

Locations

Päijät-Häme Central Hospital

Lahti, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Marianne Ylikoski, MD

Role: CONTACT

Phone: +358447195268

Email: marianne.ylikoski@phhyky.fi

Raine Tiihonen, MD, PhD

Role: CONTACT

Phone: +358444406151

Email: raine.tiihonen@phhyky.fi

Facility Contacts

Marianne Ylikoski, MD

Role: primary

Raine Tiihonen, MD, PhD

Role: backup

References

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.

Reference Type: DERIVED

PMID: 32615649 (View on PubMed)

Other Identifiers

Q321dnro 47/17

Identifier Type: -

Identifier Source: org_study_id