Analysis of Influencing Factors of Hypotension in Diabetic Patients Undergoing Dialysis

NCT05325892 | Unknown

• 1 other identifier: 200202
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemodialysis; Diabetes

Keywords

Intradialytic hypotension

Outcome Measures

Primary Outcomes (1)

• 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

  during dialysis

Study Arms (2)

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.

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.

Combination Product: This is an observational study

Interventions

This is an observational study COMBINATION_PRODUCT

This is an observational study

IDH; non-IDH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

diabetic patients with maintenance hemodialysis.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• 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 DIRECTOR

Central Study Contacts

weihua yao, bachelor

CONTACT

13521359976; 13521359976@139.com

wenhu liu, doctor

CONTACT

13901163354; wenhuliu@mail.ccmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 13, 2022
• Study Start: March 1, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: April 13, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)