HemodialysisNCT05325892
Analysis of Influencing Factors of Hypotension in Diabetic Patients Undergoing Dialysis
An observational study of Hemodialysis and Diabetes, run by Beijing Friendship Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, Diabetes
- What is being tested?
- This is an observational study
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: diabetic patients with maintenance hemodialysis.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
weihua yao, Bachelor, 13521359976, 13521359976@139.com
About this study
Official title: Prospective Analysis of Influencing Factors of Hypotension in Diabetic Patients Undergoing Dialysis
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.
Read the 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.
- 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.
- Conditions
- Hemodialysis, Diabetes
- Being tested
- This is an observational study
- Keywords
- Intradialytic hypotension
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is an observational studyCombination product
This is an observational study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: 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. Receives: Combination Product: This is an observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
IDH
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
Measured: during dialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start1 Mar 2022
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- zongli diao, doctor, Study director, Beijing Friendship Hospitalpeiyi zhou, doctor, Study director, People's Hospital of Beijing Daxing Districtguo liu, bachelor, Study director, Beijing Zhongnengjian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325892
- Sponsor's protocol ID
- 200202
- Status last verified
- Mar 2022
- First submitted
- 6 Apr 2022
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Influencing Factors of Hypotension in Diabetic Patients Undergoing Dialysis
- ClinicalTrials.gov ID
- NCT05325892
- Acronym / sponsor ID
- 200202
- Conditions
- Hemodialysis, Diabetes
- Keywords
- Intradialytic hypotension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDH | – | Combination Product: This is an observational studyDiabetic 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. |
| non-IDH | – | Combination Product: This is an observational studyDiabetic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- diabetic patients with maintenance hemodialysis.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is an observational studyThis is an observational study | Combination product | IDH, non-IDH |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zongli diao, doctor study director
Beijing Friendship Hospital
peiyi zhou, doctor study director
People's Hospital of Beijing Daxing District
guo liu, bachelor study director
Beijing Zhongnengjian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodialysis and Diabetes, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact weihua yao, bachelor (13521359976, 13521359976@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IDH (time frame: during dialysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.