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Not yet recruiting NCT07455799

Effect of Missed Dialysis Sessions on Short Term Cardiovascular Events

Observational End Stage Renal Failure, Hemodialysis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electrocardiography (ECG) and Echocardiography (ECHO).
Who it may be relevant to
Registry conditions: End Stage Renal Failure, Hemodialysis. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

the effect of missed hemodialysis sessions on the occurrence of short-term cardiovascular events in patients with end-stage renal disease receiving maintenance hemodialysis.

Detailed description

End-stage renal disease (ESRD) represents a major and growing global health burden, with a steadily increasing prevalence worldwide. Patients receiving maintenance hemodialysis (HD) experience markedly elevated rates of cardiovascular morbidity and mortality compared with the general population (1).

Cardiovascular disease accounts for nearly half of all deaths among HD patients, reflecting the combined effects of traditional cardiovascular risk factors and dialysis-specific stressors, including large volume shifts, electrolyte disturbances, chronic inflammation, and autonomic dysfunction (2).

Maintenance HD is designed to preserve physiological homeostasis through regular removal of excess fluid, electrolytes, and uremic toxins. Adherence to the prescribed dialysis schedule is therefore essential for maintaining cardiovascular stability (3).

Despite its life-sustaining role, HD is an inherently complex and time-consuming therapy, typically delivered three times weekly for several hours per session. This demanding regimen imposes substantial physical, psychological, and socioeconomic burdens on patients and contributes to persistently high rates of hospitalization and mortality (4).

Missed HD sessions or delays in treatment represent a common and clinically significant challenge in routine dialysis care, with observational studies indicating that 515% of patients miss at least one scheduled session annually. Disruption of the regular dialysis schedule results in prolonged interdialytic intervals and loss of metabolic and volume control (5).

Importantly, missed treatments are not solely attributable to patient nonadherence. A wide range of contributing factors has been identified, including logistical barriers such as unreliable transportation, long travel times to dialysis units, adverse weather conditions, and scheduling of sessions on weekends or holidays. Medical factors such as gastrointestinal symptoms, vascular access dysfunction, chronic pain, depression, and substance use further contribute to treatment nonattendance. Additionally, demographic and psychosocial factors, including older age, limited health literacy, race or ethnicity, and lack of social or marital support, play an important role (6).

The consequences of missed HD sessions extend beyond inadequate solute clearance. Prolonged interdialytic intervals lead to acute physiological derangements, including progressive fluid overload, worsening hypertension, hyperkalemia, metabolic acidosis, and accumulation of uremic toxins. These abnormalities impose significant myocardial stress and increase electrical instability (7).

The cardiovascular system of HD patients is particularly vulnerable to abrupt changes in preload and afterload. Excess interdialytic weight gain following missed sessions increases cardiac workload and predisposes patients to acute heart failure decompensation. Concurrently, electrolyte disturbances particularly hyperkalemia may precipitate malignant arrhythmias, while autonomic imbalance and heightened sympathetic activity further amplify the risk of sudden cardiac events (8).

Consistent with these pathophysiological mechanisms, studies comparing scheduled dialysis days have demonstrated higher rates of cardiovascular events following longer interdialytic gaps. Moreover, skipped treatments have been associated with sharply increased short-term risks of hospitalization and mortality, particularly within 4872 hours the missed session (9).

Additionally, Missed HD sessions have also been linked to unfavorable anemia-related outcomes, including lower hemoglobin levels and increased requirements for erythropoiesafteris-stimulating agents, further reflecting compromised dialysis adequacy

Interventions

  • Device Electrocardiography (ECG) and Echocardiography (ECHO)
    A standard 12-lead ECG will be performed for all patients within 72 hours after a missed hemodialysis session to detect abnormalities.Transthoracic echocardiography will be performed as a baseline assessment for all enrolled patients using routine institutional protocols. Repeat echocardiographic examination will be performed only if clinically indicated,Echocardiographic parameters assessed will include left ventricular ejection fraction , left ventricular hypertrophy, regional wall motion abno

Primary outcome measures

  • Incidence of short-term cardiovascular events (CVE) following missed hemodialysis sessions [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Adult patients aged ≥18 years.
  • Patients diagnosed with end-stage renal disease (ESRD).
  • Patients receiving maintenance hemodialysis on a regular schedule (three sessions per week).
  • Patients on maintenance hemodialysis for at least 3 months prior to enrolment.

Exclusion criteria

  • Patients receiving peritoneal dialysis or other forms of renal replacement therapy.
  • Patients with acute kidney injury requiring temporary dialysis.
  • Patients with documented acute cardiovascular events within 30 days prior to study enrolment.
  • Patients who undergo renal transplantation during the study period.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Assiut University Hospital — Asyut

Publications

  • Kumar P, Savant K, Balakrishnan A, Nair S, Prabhu Attur R. Impact of Interdialytic Intervals on Sudden Cardiac Death in Chronic Kidney Disease Stage 5D Patients on a Twice-Weekly Hemodialysis Schedule. Kidney Blood Press Res. 2025;50(1):420-428. doi: 10.1159/000546184. Epub 2025 May 7. PMID 40334646
  • Zhang Y, Wang J, Xing Y, Cui C, Cheng H, Chen Z, Chen H, Liu C, Wang N, Chen M. Dynamics of Cardiac Autonomic Responses During Hemodialysis Measured by Heart Rate Variability and Skin Sympathetic Nerve Activity: The Impact of Interdialytic Weight Gain. Front Physiol. 2022 May 16;13:890536. doi: 10.3389/fphys.2022.890536. eCollection 2022. PMID 35651871
  • Lim K, Nayor M, Arroyo E, Burney HN, Li X, Li Y, Shah R, Campain J, Wan D, Ting S, Hiemstra TF, Thadhani R, Moe S, Zehnder D, Larson MG, Vasan RS, Lewis GD. Impairment of Cardiovascular Functional Capacity in Mild-to-Moderate Kidney Dysfunction. Clin J Am Soc Nephrol. 2024 Dec 1;19(12):1547-1561. doi: 10.2215/CJN.0000000000000548. Epub 2024 Oct 14. PMID 39401313
  • Canaud B, Kooman JP, Selby NM, Taal M, Maierhofer A, Kopperschmidt P, Francis S, Collins A, Kotanko P. Hidden risks associated with conventional short intermittent hemodialysis: A call for action to mitigate cardiovascular risk and morbidity. World J Nephrol. 2022 Mar 25;11(2):39-57. doi: 10.5527/wjn.v11.i2.39. PMID 35433339
  • Fatovic-Ferencic S, Holubar K. The portrait and paper of a forgotten hero--Luca Stulli (1772-1828) and the Mal de Meleda of yesteryear: a 175-year anniversary. J Invest Dermatol. 2001 Jan;116(1):198-9. doi: 10.1046/j.1523-1747.2001.00225.x. No abstract available. PMID 11168819
  • Hospice nursing. A special calling. Nursing. 1997 Jan;27(1):52-7. No abstract available. PMID 9016084
  • Matise MP, Joyner AL. Gli genes in development and cancer. Oncogene. 1999 Dec 20;18(55):7852-9. doi: 10.1038/sj.onc.1203243. PMID 10630638
  • Williams P, Keshavarz-Moore E, Dunnill P. Production of cadmium sulphide microcrystallites in batch cultivation by Schizosaccharomyces pombe. J Biotechnol. 1996 Jul 31;48(3):259-67. doi: 10.1016/0168-1656(96)01520-9. PMID 8862002

Identifiers

NCT: NCT07455799 · Missed HD sessions

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗