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

This study is currently recruiting participants.
Verified October 2017 by Marjo Soini, Joint Authority for Päijät-Häme Social and Health Care
Sponsor:
ClinicalTrials.gov Identifier:
NCT03306810
First Posted: October 11, 2017
Last Update Posted: October 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Marjo Soini, Joint Authority for Päijät-Häme Social and Health Care
  Purpose

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 Intervention
Dysglycemia Arthroplasty Complications Other: AG service

Study Type: Interventional
Study Design: 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

Further study details as provided by Marjo Soini, Joint Authority for Päijät-Häme Social and Health Care:

Primary Outcome Measures:
  • Survival [ Time Frame: 1-5 years ]
    Improved survival


Secondary Outcome Measures:
  • Complications [ Time Frame: 1-5 years ]
    Less complications after AG-service


Estimated Enrollment: 600
Actual Study Start Date: September 26, 2017
Estimated Study Completion Date: December 31, 2025
Estimated Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03306810


Contacts
Contact: Marianne Ylikoski, MD +358447195268 marianne.ylikoski@phhyky.fi
Contact: Raine Tiihonen, MD, PhD +358444406151 raine.tiihonen@phhyky.fi

Locations
Finland
Päijät-Häme Central Hospital Recruiting
Lahti, Finland, 15850
Contact: Marianne Ylikoski, MD    +358447195268    marianne.ylikoski@phhyky.fi   
Contact: Raine Tiihonen, MD, PhD    +3584406151    raine.tiihonen@phhyky.fi   
Sponsors and Collaborators
Joint Authority for Päijät-Häme Social and Health Care
Investigators
Principal Investigator: Marianne Ylikoski, MD Päijänne Tavastia Central Hospital
  More Information

Responsible Party: Marjo Soini, CRA, Joint Authority for Päijät-Häme Social and Health Care
ClinicalTrials.gov Identifier: NCT03306810     History of Changes
Other Study ID Numbers: Q321dnro 47/17
First Submitted: September 19, 2017
First Posted: October 11, 2017
Last Update Posted: October 11, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
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, Joint Authority for Päijät-Häme Social and Health Care:
Perioperative complications
Dysglycemia management team
Nurse Practitioner
Hospital