Recognition and Treatment of Dysglycemia. AGS - Acute Glucose Service

Sponsor
Joint Authority for Päijät-Häme Social and Health Care (Other)
Overall Status
Recruiting
CT.gov ID
NCT03306810
Collaborator
(none)
600
1
2
99.2
6.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: AG service
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Recognition and Treatment of Dysglycemia in Elective Knee and Hip Arthroplasties. AGS - Acute Glucose Service
Actual Study Start Date :
Sep 26, 2017
Anticipated Primary Completion Date :
Dec 31, 2019
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Survival [1-5 years]

    Improved survival

Secondary Outcome Measures

  1. Complications [1-5 years]

    Less complications after AG-service

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Päijät-Häme Central Hospital Lahti Finland 15850

Sponsors and Collaborators

  • Joint Authority for Päijät-Häme Social and Health Care

Investigators

  • Principal Investigator: Marianne Ylikoski, MD, Päijänne Tavastia Central Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marjo Soini, CRA, Joint Authority for Päijät-Häme Social and Health Care
ClinicalTrials.gov Identifier:
NCT03306810
Other Study ID Numbers:
  • Q321dnro 47/17
First Posted:
Oct 11, 2017
Last Update Posted:
Oct 11, 2017
Last Verified:
Oct 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marjo Soini, CRA, Joint Authority for Päijät-Häme Social and Health Care

Study Results

No Results Posted as of Oct 11, 2017