NCT03306810

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 19, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

September 26, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

2.3 years

First QC Date

September 19, 2017

Last Update Submit

October 10, 2017

Conditions

Keywords

Perioperative complicationsDysglycemia management teamNurse PractitionerHospital

Outcome Measures

Primary Outcomes (1)

  • Survival

    Improved survival

    1-5 years

Secondary Outcomes (1)

  • Complications

    1-5 years

Study Arms (2)

AG service

ACTIVE COMPARATOR

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

Without AG service

NO INTERVENTION

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.

Interventions

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.

AG service

Eligibility Criteria

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

You may qualify if:

  • Patients aged \> 18 years
  • Elective knee and hip arthroplasty patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Päijät-Häme Central Hospital

Lahti, 15850, Finland

RECRUITING

Related Publications (1)

  • 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 Officials

  • Marianne Ylikoski, MD

    Päijät Häme Central Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianne Ylikoski, MD

CONTACT

Raine Tiihonen, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CRA

Study Record Dates

First Submitted

September 19, 2017

First Posted

October 11, 2017

Study Start

September 26, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2025

Last Updated

October 11, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations