Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05325892 |
| Other study ID # |
200202 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2022 |
| Est. completion date |
September 30, 2022 |
Study information
| Verified date |
March 2022 |
| Source |
Beijing Friendship Hospital |
| Contact |
weihua yao, bachelor |
| Phone |
13521359976 |
| Email |
13521359976[@]139.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Hypotension (IDH) during dialysis is a common complication in hemodialysis, and the incidence
is 20-50% in hemodialysis patients, the proportion of diabetic patients with IDH is 26.7%,
which is much higher than that of non-diabetic patients. Currently, there are few studies on
the influencing factors and related thresholds of IDH in diabetic patients.A total of 180
eligible patients were selected from Beijing Friendship Hospital, Beijing Nuclear Industry
Hospital, Beijing Daxing District People's Hospital, Beijing Zhongneng Jian Hospital. General
data of patients were collected. Dialysis prescription Blood pressure biochemical parameters
and cardiac color ultrasound parameters were divided into IDH group and non-IDH group
according to the incidence of IDH during dialysis Logistic regression was used to analyze the
influencing factors of IDH, and ROC curve was used to explore the threshold of related
factors.
Description:
research background：According to the executive summary of 2015 annual data report of China
Kidney Disease Network (CK-NET), hemodialysis is the main way of renal replacement therapy,
accounting for 91.0% of all dialysis patients, and the prevalence rate of diabetic dialysis
patients accounts for 26.7 of hemodialysis patients.Intradialytic hypotension (IDH) is a
common complication in hemodialysis, which is related to high morbidity and mortality.There
are significant differences in the incidence of IDH in patients with different diagnostic
criteria, and there are also significant differences in the incidence of IDH in different
populations with similar definitions.At present, Kidney Disease: Improving Global Outcomes
(KDIGO) has not provided the diagnostic criteria for IDH.China's nephrology community has not
reached a consensus on this.The diagnostic criteria for IDH recommended by KDOQI and European
Best Practice Guidelines (EBPG) are a 20 mmHg decrease in arterial systolic blood pressure
(SBP) during dialysis, or a 10 mmHg decrease in mean arterial blood pressure MmHg,
accompanied by headache, malaise, convulsions, nausea, vomiting, irritability and other
hypotension-related symptoms or related intervention measures during dialysis.In previous
retrospective studies, it is not easy for researchers to obtain the clinical symptoms and
related management measures of PATIENTS with IDH. Most retrospective studies take the value
of patients' blood pressure drop as the reference standard for the occurrence of IDH, and
further prospective studies are needed on the influencing factors of IDH.The majority of
diabetic patients with autonomic nervous dysfunction and decreased vascular regulation are at
high risk of IDH.A large number of studies have proved that IDH is more likely to occur in
patients with diabetes, but there are few prospective studies on the risk factors of IDH in
patients with diabetes.
By collecting the general information of diabetes patients, age of dialysis, history of
coronary heart disease, history of hypertension, current antihypertensive drugs, postural
hypotension, dry weight, ultrafiltration volume, ultrafiltration rate, pre-dialysis blood
pressure, blood pressure during dialysis, and blood pressure after dialysis, In dialysis
hypotension associated symptoms and treatment measures, albumin, hemoglobin, blood lipid,
BNP, before and after dialysis, blood sugar, blood biochemical indexes such as calcium, heart
colour to exceed the main parameters (EF %, E/A, aortic root diameter), statistical analysis,
to explore the influence factors of hypotension in dialysis patients with diabetes and
related threshold. The above examinations are all tests in the normal clinical treatment
process, and the frequency and items of patients' tests will not be increased.
4. Research scheme research design prospective cohort study Research object Study population:
Maintenance hemodialysis patients treated in Beijing Zhongnengjian Hospital, Beijing Daxing
District People's Hospital, Beijing Friendship Hospital, Capital Medical University, From
March 1, 2021 to September 30, 2022 Planned enrollment: 180 patients, including 60 patients
from Beijing Friendship Hospital affiliated to Capital Medical University, 40 patients from
Beijing Zhongnengjian Hospital and 40 patients from Beijing Daxing District People's Hospital
Inclusion criteria: ① Diagnosis of end-stage renal disease; ② Maintenance hemodialysis >3
months; ③ Age >18; ④ Dialysis 3 times a week; ⑤ Diagnosed with diabetes Exclusion criteria:
1.① Acute renal failure; ② Acute heart failure; ③ Dialysis with ultrafiltration curve or
sodium curve mode; ④ The upper limb blood pressure can not be measured ⑤ the systolic blood
pressure before penetration <90mmHg; ⑥ Malignant tumor fluid state.
research process A total of 180 patients eligible for inclusion were screened from Beijing
Friendship Hospital, Beijing Nuclear Industry Hospital, Beijing Daxing District People's
Hospital, Beijing Zhongnengjian Hospital, Capital Medical University, and their general data
from 2022-3-1 to 2022-9-30 were collected The main parameters of cardiac color ultrasound
were divided into IDH group and non-IDH group according to the occurrence of IDH in dialysis.
The influencing factors of IDH were analyzed by logistic regression, and the threshold of
related factors of IDH was explored by ROC curve.
Observation indexes: prospective collection history of dialysis age age and gender in
patients with coronary heart disease History of high blood pressure Present use of
antihypertensive drugs without orthostatic hypotension dry weight, ultrafiltration volume of
the ultrafiltration rate through blood pressure before dialysis after dialysis, blood
pressure and blood pressure in the dialysis hypotension related symptoms and treatment
measures Hemoglobin before and after the blood lipid albumin dialysis blood sugar Blood
calcium, BNP and other biochemical indicators Main parameters of cardiac color ultrasound
(EF% E/A aortic root diameter).
Determination of sample size: Combined with previous studies, estimate according to sample
size formula.
Informed consent This study was an observational study, in which data were recorded during
the diagnosis and treatment of patients, consent was solicited and informed consent was
signed.
Statistical methods: SPSS20.0 statistical software was used for statistical analysis,
normality test was performed for continuous variables, mean standard deviation was used for
numerical variables conforming to normal distribution, T test was used for inter-group
comparison, counting data was expressed as %, chi-square test was used for comparison and
multivariate Logistic regression was used to analyze the gender and age of patients in the
two groups Blood ALB blood Hb BNP blood lipid cardiac color ultrasound EF% E/A Blood pressure
UFR dry weight in the aortic root before transportion. ROC curve was used to analyze the
threshold of important factors influencing the incidence of hypotension during dialysis. 0.05
was considered statistically significant.
Quality control: This study is a prospective study. According to literature and clinical
experience, patient data are collected and input into the database. Experienced doctors check
and give feedback when problems are found. Develop daily plans and consistency check
procedures in advance to ensure accurate, complete and comprehensive data; Identify and
address errors and omissions; Keep records of relevant documents, especially the original
database, to trace back the quality control activities.
