- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07455799
Effect of Missed Dialysis Sessions on Short Term Cardiovascular Events
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Amna Abdelnasser Taher, Resident
- Phone Number: +01080583753
- Email: a01094597745@gmail.com
Study Locations
-
-
Assiut Governorate
-
Asyut, Assiut Governorate, Egypt
- Assiut University hospital
-
Contact:
- Amna A Taher, Resident
- Phone Number: +01080583753
- Email: a01094597745@gmail.com
-
Principal Investigator:
- Amna A Taher, Resident
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of short-term cardiovascular events (CVE) following missed hemodialysis sessions
Time Frame: 1 year
|
Short-term cardiovascular events will be defined as the occurrence of acute coronary syndrome, acute decompensated heart failure, documented arrhythmias, sudden cardiac death, or cerebrovascular events occurring within 72 hours after a missed hemodialysis session.
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohamed Ali Touhami Ibrahim, Professor
- Principal Investigator: Eman Mohamed Ibrahim Kamed Hussain, Assistant lecture
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- Hospice nursing. A special calling. Nursing. 1997 Jan;27(1):52-7. No abstract available.
- Matise MP, Joyner AL. Gli genes in development and cancer. Oncogene. 1999 Dec 20;18(55):7852-9. doi: 10.1038/sj.onc.1203243.
- 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.
- Stuard S, Maddux FW, Canaud B. Why High-Volume Post-Dilution Hemodiafiltration Should Be the New Standard in Dialysis Care: A Comprehensive Review of Clinical Outcomes and Mechanisms. J Clin Med. 2025 Jul 9;14(14):4860. doi: 10.3390/jcm14144860.
- Marinetti MT. Health workforce shortage in the United Kingdom and prospects of personnel recruitment from abroad. Cah Sociol Demogr Med. 2003;43(1):71-114. No abstract available.
- Francis A, Harhay MN, Ong ACM, Tummalapalli SL, Ortiz A, Fogo AB, Fliser D, Roy-Chaudhury P, Fontana M, Nangaku M, Wanner C, Malik C, Hradsky A, Adu D, Bavanandan S, Cusumano A, Sola L, Ulasi I, Jha V; American Society of Nephrology; European Renal Association; International Society of Nephrology. Chronic kidney disease and the global public health agenda: an international consensus. Nat Rev Nephrol. 2024 Jul;20(7):473-485. doi: 10.1038/s41581-024-00820-6. Epub 2024 Apr 3.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Pathological Conditions, Signs and Symptoms
- Renal Insufficiency
- Renal Insufficiency, Chronic
- Diagnostic Techniques and Procedures
- Diagnosis
- Diagnostic Imaging
- Diagnostic Techniques, Cardiovascular
- Heart Function Tests
- Electrodiagnosis
- Cardiac Imaging Techniques
- Ultrasonography
- Electrocardiography
- Echocardiography
Other Study ID Numbers
- Missed HD sessions
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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