Evaluation of Relationship Between Preoperative Fibrinogen/Albumin Ratio and Morbidity After Hip Fracture Operations in Oldest Old Patients: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Morbidity
研究概览
简要总结
Due to the aging of populations, hip fracture operations are increasing from year to year. This operations have many complications also high morbidity and the mortality. Population of this study is oldest old age patients who will have an operation because of hip fracture.
The primary outcome of this study is evaluation of relationship between preoperative fibrinogen/albumin ratio and the morbidity after hip fracture operations. The secondary outcomes of this study is evaluation of relationships between fibrinogen/albumin ratio and mortality, length of stay in ICU, length of stay in hospital, postoperative complications, blood product consumption. The study will be completed after the records of preoperative, intraoperative data and the data of the first 30 days postoperatively in this population.
详细描述
Due to the aging of populations, hip fracture operations are increasing from year to year. This operations have many complications also high morbidity and the mortality. Elderly people are divided into 3 groups according to their age. Elderly people whose aged over 85 years as oldest-old. Population of this study is oldest old patients who will have an operation because of hip fracture.
The research is as a single-center, prospective observational study. The primary outcome of this study is evaluation of relationship between preoperative fibrinogen/albumin ratio and the morbidity after hip fracture operations. Age-Adjusted Charlson Comorbidity Index, Nottingham Hip Fracture Score and Clinical Frailty Scale Score will be calculated at the preoperative visit for each patient before operation. Investigators planned to use these three scores to determine morbidity.
Age-Adjusted Charlson Comorbidity Index AACCI): Age-modified version of the Charlson Comorbidity Index. Charlson Comorbidity Index predicts the ten-year mortality for a patient who may have a range of comorbid conditions for example diabetes, myocardial infarction, dementia, liver disease, lymphoma. Each comorbid condition has a separate point. 71 years old and older patients have +4 points for scoring of Age-Adjusted Charlson Comorbidity Index. The sum of the scores gives the total score. The minimum score is 4 for oldest old patients. Higher scores mean a worse outcome.
Nottingham Hip Fracture Score (NHFS) is a scoring system that reliably predicts 30 day mortality for patients after hip fracture. Development and validation of a preoperative scoring system to predict 30 day mortality in patients undergoing hip fracture surgery. To calculate the NHFS, it is necessary to calculate the abbreviated mental test score of 10 points in total. The minimum score is 3 for oldest old patients. The maximum score is 10. Higher scores mean a worse outcome.
The Clinical Frailty Scale (CFS) is a judgement-based frailty tool that evaluates specific domains including comorbidity, function, and cognition to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill). Higher scores mean a worse outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 85 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥85 years old patients
- •Primary operation
- •Undergoing hip fracture surgery
- •Receiving consent from patients or guardians that they accept regional anesthesia
- •Not having active infection
- •American Society of Anesthesiologists (ASA) 1-4
- •BMI< 40 kg/m²
排除标准
- •Refusal regional anesthesia
- •Infection on regional anesthesia application area
- •Infection in the central nervous system
- •Coagulopathy
- •Known allergy against local anesthetics
- •Severe hepatic insufficiency
- •Haematologic disease
- •Rheumatological disease
- •Autoimmune disease
结局指标
主要结局
Morbidity
时间窗: Preoperative (before induction of anesthesia)
Age Adjusted Charlson Comorbidity Index will be calculated for morbidity estimation. This score predicts the ten-year mortality for a patient who may have a range of comorbid conditions. The minimum score is 4 for oldest old patients. The maximum score is 34. Higher scores mean a worse outcome.
次要结局
- Nottingham Hip Fracture Score(Preoperative (before induction of anesthesia))
- Clinical Frailty Scale Score(Preoperative (before induction of anesthesia))
- Length of stay in ICU(Up to 30 days)
- Amount of intraoperative and postoperative blood product replacement(Up to discharge (up to 30 days))
- Mortality(Up to 30 days)
- Length of stay in hospital(Up to 30 days)
- Postoperative complications(Up to discharge (up to 30 days))
研究者
Nur Canbolat
Principal Investigator, M.D.
Istanbul University