- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05325892
Analysis of Influencing Factors of Hypotension in Diabetic Patients Undergoing Dialysis
Prospective Analysis of Influencing Factors of Hypotension in Diabetic Patients Undergoing Dialysis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: weihua yao, Bachelor
- Phone Number: 13521359976
- Email: 13521359976@139.com
Study Contact Backup
- Name: wenhu liu, doctor
- Phone Number: 13901163354
- Email: wenhuliu@mail.ccmu.edu.cn
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100050
- Recruiting
- Beijing Friendship Hospital, Capital Medical University
-
Contact:
- weihua yao, Bachelor
- Phone Number: 13521359976
- Email: 13521359976@139.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
IDH
Diabetic patients with maintenance hemodialysis who developed hypotension during hemodialysis therapy.Intradialytic hypotension (IDH) is defined as a decrease in systolic blood pressure by ≥20 mm Hg or a decrease in MAP by ≥10 mm Hg associated with symptoms that include: abdominal discomfort; yawning; sighing; nausea; vomiting; muscle cramps; restlessness; dizziness or fainting; and anxiety.
|
This is an observational study
|
non-IDH
Diabetic patients with maintenance hemodialysis who did not develop hypotension during hemodialysis treatment.Intradialytic hypotension (IDH) is defined as a decrease in systolic blood pressure by ≥20 mm Hg or a decrease in MAP by ≥10 mm Hg associated with symptoms that include: abdominal discomfort; yawning; sighing; nausea; vomiting; muscle cramps; restlessness; dizziness or fainting; and anxiety.
|
This is an observational study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IDH
Time Frame: during dialysis
|
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
|
during dialysis
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: zongli diao, doctor, Beijing Friendship Hospital
- Study Director: peiyi zhou, doctor, People's Hospital of Beijing Daxing District
- Study Director: guo liu, bachelor, Beijing Zhongnengjian Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200202 (Other Identifier: IGTD Protocol no.)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
Guang NingRecruitingType 2 Diabetes Mellitus | Type1 Diabetes Mellitus | Monogenetic Diabetes | Pancreatogenic Diabetes | Drug-Induced Diabetes Mellitus | Other Forms of Diabetes MellitusChina
-
University of Trás-os-Montes and Alto DouroCompletedType 2 Diabetes Mellitus | Diabetes-Related ComplicationsPortugal
-
Northern Care Alliance NHS Foundation TrustBrighter ABCompletedDiabetes type1 | Diabetes type2United Kingdom
-
VeraLight, Inc.InLight SolutionsUnknownGestational Diabetes | Insulin Dependent Diabetes | Non Insulin Dependent DiabetesUnited States
-
Garvan Institute of Medical ResearchWeizmann Institute of ScienceActive, not recruitingType 2 Diabetes Mellitus | Pre DiabetesAustralia
-
Oregon State UniversitySanofiCompletedType I or Type II Diabetes (Excludes Gestational Diabetes)
-
Taichung Veterans General HospitalNational Health Research Institutes, TaiwanRecruitingDiabetes Complications | Type 2 Diabetes | Maturity-Onset Diabetes of the Young (MODY)Taiwan
-
University of RoehamptonRecruitingType2 Diabetes Mellitus | Pre DiabetesUnited Kingdom
-
Peking Union Medical College HospitalUnknownType 2 Diabetes Mellitus | Type 1 Diabetes Mellitus | Gestational Diabetes Mellitus | Pancreatogenic Diabetes Mellitus | Pregestational Diabetes Mellitus | Diabetes Patients in Perioperative PeriodChina
Clinical Trials on This is an observational study
-
Isabelle Herter-AeberliBerner FachhochschuleRecruiting
-
Swiss Federal Institute of TechnologyAlzheimer's Drug Discovery FoundationRecruiting
-
Asklepios Biopharmaceutical, Inc.RecruitingParkinson's Disease | Multiple System Atrophy | Multiple System Atrophy, Parkinson VariantUnited States, Poland
-
Hadassah Medical OrganizationSuspended
-
Universidad de GranadaInstitut d'Investigació Biomèdica de Bellvitge; University of Seville; National... and other collaboratorsRecruitingCancer | Dietary Habits | Metabolic Disease | Food Habits | Nutrition, HealthySpain
-
Swiss Federal Institute of TechnologyAlzheimer's Drug Discovery FoundationRecruiting
-
Beijing Friendship HospitalRecruitingCognitive Dysfunction | Kidney Failure, Chronic | Magnetic Resonance ImagingChina
-
University Hospital HeidelbergCompletedMucopolysaccharidosis Type I | Mucopolysaccharidosis Type II | Coping Behavior | Mucopolysaccharidosis Type III | Behavior DisordersGermany
-
Linkoeping UniversityCompletedFrailty | Non ST Elevation Myocardial Infarction (NSTEMI)Sweden
-
University of LeicesterCompletedAcute Kidney InjuryUnited Kingdom