Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05272072 |
| Other study ID # |
2021/1968 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 30, 2022 |
| Est. completion date |
March 1, 2023 |
Study information
| Verified date |
March 2023 |
| Source |
Istanbul University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
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.
Description:
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.
The secondary outcomes of this study is evaluation of relationships between
fibrinogen/albumin ratio and Nottingham Hip Fracture Score, Clinical Frailty Scale Score,
mortality, length of stay in ICU, length of stay in hospital, blood product consumption,
postoperative complications. Postoperative complications are divided into pulmonary,
cardiovascular, hepatic, renal complications, bleeding, electrolyte imbalance, wound site
infections, delirium and other. Postoperative pulmonary complications (PPC) encompass almost
any complication affecting the respiratory system after anaesthesia and surgery. PPCs are
bronchospasm, aspiration pneumonia, atelectasis, pneumonia, pleural effusion, pneumothorax,
pulmonary embolism, respiratory failure, acute respiratory distress syndrome,
tracheobronchitis etc. Postoperative cardiac complications are resistant hypotension-
hypertension, new onset of dysrhythmias like atrial fibrillation, acute coronary syndromes,
cardiac failure, cardiogenic shock. Investigators will follow up postoperative hemogram and
record amount of blood transfused to investigate bleeding. Investigators will follow up serum
creatinin and urea level, use Kidney Disease Improving Global Outcomes (KDIGO) criteria for
acute renal failure and note necessity of hemodialysis or hemodiafiltration.
Before the study, it was determined that at least 108 patients should be collected in the
power analysis performed with the help of similar literature data. After collecting the
demographic and peroperative data up to postoperative 30 days of the patients, the data will
be transferred to the statistical program called SPSS and statistical analysis will be made.
The investigators study does not contain any modifications other than the investigators daily
routine practices.
