跳至主要内容
临床试验/NCT03306810
NCT03306810招募中不适用

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

Joint Authority for Päijät-Häme Social and Health Care1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2017年9月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
600
试验地点
1
主要终点
Survival

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

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

研究组 & 干预措施

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.

干预措施: AG service (Other)

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.

结局指标

主要结局

Survival

时间窗: 1-5 years

Improved survival

次要结局

  • Complications(1-5 years)

研究者

发起方
Joint Authority for Päijät-Häme Social and Health Care
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marjo Soini

CRA

Joint Authority for Päijät-Häme Social and Health Care

研究点 (1)

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