Clinical trial NCT06333574: Weight Management of Dialysis Patients
Official title: Clinical Randomized Controlled Trial of Weight Intervention to Improve Volumetric Load in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemodialysis
Life Quality
Interdialytic Weight Gain
Cardiovascular Events
Hypertension
Dry Weight
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to Improve the quality of life in Hemodialysis patient. The main questions it aims to answer are:

* \[Improve the self-compliance of dialysis patients with weight management\]
* \[alleviate the volume load of dialysis patients and reduce cardiovascular complications\] Participants will be divided into two groups based on a weight management regimen： Control group: received routine outpatient management. Specific methods: The dialysis doctor registered the information of the patient\&#39;s weight and blood pressure at the end of dialysis, and informed the patient of the purpose, role and importance of weight management.

Intervention group: On the basis of routine outpatient management, patients or their family members were subjected to remote follow-up management based on wechat, and the follow-up time was 6 months. Specific methods: Same as the control group, the information of weight and blood pressure of the patients was registered at the end of dialysis, and the purpose, role and importance of weight management were informed to the patients. On this basis, a special wechat signal is set up to add patients or patients\&#39; family members as wechat friends and establish a wechat interaction platform with patients. In the interdialysis period, remind patients to weigh themselves through wechat (the time of each weighing is fixed, preferably consistent with the time of weighing in the hemodialysis center), control the weight gain during the interdialysis period not to exceed 4.5% of dry weight, and inform patients again about the purpose, role and importance of weight management.


Eligibility criteria: Inclusion Criteria:

* Age ≥18;
* Dialysis age ≥3 months;
* Survival ≥12 months;
* Patients themselves or family members can use wechat;
* Informed consent

Exclusion Criteria:

* Have a cognitive or intellectual disability unable to read and understand SMS;
* Have mental illness;
* Other serious complications occurred

Primary outcomes:
measure: Adverse event rate
timeFrame: 4, 8, and 12 weeks after intervention
measure: Rate of completion
timeFrame: 4, 8, and 12 weeks after intervention
Secondary outcomes:
measure: dialysis related symptoms
timeFrame: 4, 8, and 12 weeks after treatment
measure: Laboratory index
timeFrame: 4, 8, and 12 weeks after treatment
measure: level of Ga
timeFrame: 4, 8, and 12 weeks after treatment
measure: level of P
timeFrame: 4, 8, and 12 weeks after treatment
measure: level of PTH
timeFrame: 4, 8, and 12 weeks after treatment
measure: level of K
timeFrame: 4, 8, and 12 weeks after treatment
measure: level of Na
timeFrame: 4, 8, and 12 weeks after treatment
measure: level of Cl
timeFrame: 4, 8, and 12 weeks after treatment
measure: concentration of albumin and prealbumin
timeFrame: 4, 8, and 12 weeks after treatment
measure: Laboratory index of total protein
timeFrame: 4, 8, and 12 weeks after treatment
measure: Dialysis efficiency \ dialysis adequacy (KTV)
timeFrame: 4, 8, and 12 weeks after treatment
Other outcomes:
Locations:
Study officials:
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