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Epidemiology And Risk Factors Of Intradialytic Hypotension In Maintenance Hemodialysis Patients

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Summary

A prospective multicenter observational study (NCT07545629) has been registered on ClinicalTrials.gov to estimate the incidence and prevalence of intradialytic hypotension (IDH) in adult patients receiving maintenance hemodialysis and to explore risk factors including patient characteristics, cardiovascular status, volume status, and dialysis-related parameters. Participants meeting predefined inclusion and exclusion criteria will have routine clinical information collected and blood pressure and related symptoms recorded across dialysis sessions during a defined observation period. The findings may help clinicians optimize dialysis prescriptions and monitoring strategies to reduce IDH occurrence and its adverse consequences.

“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.”

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This ClinicalTrials.gov registration describes NCT07545629, a prospective multicenter observational study focused on intradialytic hypotension (IDH) in adult maintenance hemodialysis patients. The study will collect demographics, primary kidney disease, comorbidities, medications, dialysis vintage, and dialysis prescription data, then record blood pressure and symptoms across dialysis sessions to document IDH frequency, severity, and patterns. The primary goals are to estimate IDH incidence and prevalence and explore risk factors such as cardiovascular status, volume status, and dialysis parameters. Affected parties include dialysis providers and nephrology researchers who may use findings to refine dialysis prescription protocols and improve patient monitoring to reduce IDH-related adverse outcomes.

Archived snapshot

Apr 22, 2026

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Epidemiology And Risk Factors Of Intradialytic Hypotension In Maintenance Hemodialysis Patients

Observational NCT07545629 Kind: OBSERVATIONAL Apr 22, 2026

Abstract

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

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Last updated

Classification

Agency
NIH
Published
April 22nd, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07545629

Who this affects

Applies to
Healthcare providers Patients
Industry sector
6211 Healthcare Providers
Activity scope
Clinical research Observational study
Geographic scope
United States US

Taxonomy

Primary area
Public Health
Operational domain
Clinical Operations
Topics
Healthcare

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