Epidemiology And Risk Factors Of Intradialytic Hypotension In Maintenance Hemodialysis Patients

NCT07545629 | Completed

• 1 other identifier: 2025-61-02
• Study Type: observational
• Target: 395
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, multicenter observational study aims to describe how often intradialytic hypotension (IDH) occurs and to identify its risk factors in adult patients receiving maintenance hemodialysis. Intradialytic hypotension is a common complication during dialysis that can lead to symptoms, organ hypoperfusion, and interruption of treatment. Participants will be adults on regular maintenance hemodialysis who meet predefined inclusion and exclusion criteria. Routine clinical information will be collected, including demographics, primary kidney disease, comorbidities, medications, dialysis vintage, dialysis prescription (ultrafiltration volume and rate, dialysate composition, treatment time), and standard laboratory tests. During a defined observation period, blood pressure and related symptoms will be recorded across dialysis sessions to document the frequency, severity, and patterns of IDH. The main goals are to estimate the incidence and prevalence of intradialytic hypotension in maintenance hemodialysis patients and to explore potential risk factors, such as patient characteristics, cardiovascular status, volume status, and dialysis-related parameters. The findings may help clinicians better recognize patients at high risk of IDH and optimize dialysis prescriptions and monitoring strategies to reduce the occurrence of IDH and its adverse consequences.

Conditions

Intradialytic Hypotension; Chronic Kidney Failure; Hemodialysis; Chronic Kidney Disease, Stage IV (Severe); End-stage Renal Disease (ESRD)

Keywords

Maintenance hemodialysis; Intradialytic hypotension (IDH); Ultrafiltration rate (UFR); Interdialytic weight gain (IDWG); Blood pressure variability; Dialysate sodium; Volume status; Cardiovascular comorbidity; Prospective observational; Multicenter

Outcome Measures

Primary Outcomes (1)

• Incidence Of Intradialytic Hypotension During A Single Maintenance Hemodialysis Session

  Proportion of enrolled maintenance hemodialysis patients who experience intradialytic hypotension (IDH) during one observed hemodialysis session. IDH is defined as a decrease in systolic blood pressure (SBP) by 20-40 mmHg from pre-dialysis or during dialysis, with or without related symptoms, according to pre-specified criteria.

  From the start of the observed hemodialysis session to the end of the same session (approximately 3.5-4 hours).

Secondary Outcomes (7)

• Incidence Of Asymptomatic IDH

  From the start of the observed hemodialysis session to the end of the same session (approximately 3.5-4 hours).

• Distribution Of Time To Onset Of Intradialytic Hypotension

  From the start of the observed hemodialysis session to the end of the same session (approximately 3.5-4 hours).

• Association Between Pre-Dialysis Mean Arterial Pressure And IDH

  From pre-dialysis blood pressure assessment immediately before the session to the end of the same hemodialysis session (approximately 3.5-4 hours).

• Association Between Interdialytic Weight Gain And IDH

  From the pre-dialysis weight assessment immediately before the session to the end of the same hemodialysis session (approximately 3.5-4 hours).

• Association Between Pre-Dialysis Serum Potassium And IDH

  Based on the most recent pre-dialysis serum potassium value within 3 months prior to the observed session and IDH occurrence during that single hemodialysis session (approximately 3.5-4 hours).

Study Arms (1)

Maintenance Hemodialysis Cohort

Adults with end-stage renal disease receiving routine maintenance hemodialysis at participating centers. Prospective observation over approximately 3 months; no study-assigned interventions. Standard dialysis care per local practice. Data collected include demographics, comorbidities, medications, dialysis vintage, prescription (UF volume/rate, dialysate sodium/calcium/bicarbonate, temperature, treatment time), blood pressure before/during/after dialysis, IDH symptoms, and clinical responses (e.g., UF reduction, saline, cooling). Routine labs as available.

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

Adults with end-stage renal disease receiving routine maintenance hemodialysis at participating centers. Consecutive eligible patients will be observed during one scheduled dialysis session to estimate single-session IDH incidence and explore associated factors.

You may qualify if:

• Adults (≥18 years) with end-stage renal disease on maintenance hemodialysis
• Receiving thrice-weekly (or routine) in-center hemodialysis for ≥3 months before enrollment
• Scheduled for a standard hemodialysis session of approximately 3-5 hours on the study day
• Able to provide informed consent (or via legally authorized representative, if applicable)

You may not qualify if:

• Acute medical instability precluding observation of a routine dialysis session (e.g., active sepsis requiring vasopressors, uncontrolled arrhythmias)
• Recent acute coronary syndrome or stroke within 3 months
• Pre-dialysis systolic blood pressure \<90 mmHg on the study day before starting dialysis
• Ongoing active major bleeding or anticipated urgent transfusion during the session
• Pregnancy
• Participation in an interventional trial expected to alter intradialytic blood pressure during the observed session

Sponsors & Collaborators

• First Affiliated Hospital of Wannan Medical College: lead
• Wuhu City Second People's Hospital: collaborator
• Wuhu County Traditional Chinese Medicine Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)

Wuhu, Anhui, 241001, China

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start: February 15, 2025
• Primary Completion: February 28, 2025
• Study Completion: December 29, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)