End Stage Renal Failure, HemodialysisNCT07455799
Effect of Missed Dialysis Sessions on Short Term Cardiovascular Events
An observational study of End Stage Renal Failure, Hemodialysis, run by Assiut University at 1 site in Egypt.
Trial summary
the effect of missed hemodialysis sessions on the occurrence of short-term cardiovascular events in patients with end-stage renal disease receiving maintenance hemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- End Stage Renal Failure, Hemodialysis
- What is being tested?
- Electrocardiography (ECG) and Echocardiography (ECHO)
- Type of treatment
- Medical device
- How many people
- 225 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hemodialysis Unit of Internal Medicine Department
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University Hospital
Asyut, Assiut Governorate
Amna A Taher, Resident, +01080583753, a01094597745@gmail.com
Amna A Taher, Resident
About this study
the effect of missed hemodialysis sessions on the occurrence of short-term cardiovascular events in patients with end-stage renal disease receiving maintenance hemodialysis.
Read the 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
- Conditions
- End Stage Renal Failure, Hemodialysis
- Being tested
- Electrocardiography (ECG) and Echocardiography (ECHO)
- Keywords
- Renal failure, Missed sessions of HD
- Medical subject headings
- Renal Insufficiency, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrocardiography (ECG) and Echocardiography (ECHO)Device
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 abnormalities, diastolic function, and right ventricular function
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of short-term cardiovascular events (CVE) following missed hemodialysis sessions
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Failure, HemodialysisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amna Abdelnasser Taher, Assiut University
- Investigators
- Mohamed Ali Touhami Ibrahim, Professor, Principal investigatorEman Mohamed Ibrahim Kamed Hussain, Assistant lecture, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455799
- Sponsor's protocol ID
- Missed HD sessions
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 40334646Zhang 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.
PubMed 35651871Lim 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.
PubMed 39401313Canaud 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.
PubMed 35433339Fatovic-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.
PubMed 11168819Hospice nursing. A special calling. Nursing. 1997 Jan;27(1):52-7. No abstract available.
PubMed 9016084Matise MP, Joyner AL. Gli genes in development and cancer. Oncogene. 1999 Dec 20;18(55):7852-9. doi: 10.1038/sj.onc.1203243.
PubMed 10630638Williams 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.
PubMed 8862002Stuard 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.
PubMed 40725552Marinetti 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.
PubMed 12693356Francis 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.
PubMed 38570631
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Missed Dialysis Sessions on Short Term Cardiovascular Events
- ClinicalTrials.gov ID
- NCT07455799
- Acronym / sponsor ID
- Missed HD sessions
- Conditions
- End Stage Renal Failure, Hemodialysis
- Keywords
- Renal failure, Missed sessions of HD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodialysis Unit of Internal Medicine Department
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 abnormalities, diastolic function, and right ventricular function | Device | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Results publication: PubMed 40334646Kumar 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.
- Results publication: PubMed 35651871Zhang 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.
- Results publication: PubMed 39401313Lim 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.
- Results publication: PubMed 35433339Canaud 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.
- Results publication: PubMed 11168819Fatovic-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.
- Results publication: PubMed 9016084Hospice nursing. A special calling. Nursing. 1997 Jan;27(1):52-7. No abstract available.
- Results publication: PubMed 10630638Matise MP, Joyner AL. Gli genes in development and cancer. Oncogene. 1999 Dec 20;18(55):7852-9. doi: 10.1038/sj.onc.1203243.
- Results publication: PubMed 8862002Williams 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.
- Results publication: PubMed 40725552Stuard 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.
- Results publication: PubMed 12693356Marinetti 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.
- Results publication: PubMed 38570631Francis 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.
Related trials for End Stage Renal Failure, Hemodialysis
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Ali Touhami Ibrahim, Professor principal investigator
Eman Mohamed Ibrahim Kamed Hussain, Assistant lecture principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Failure, Hemodialysis, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amna Abdelnasser Taher, Resident (+01080583753, a01094597745@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of short-term cardiovascular events (CVE) following missed hemodialysis sessions (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07455799, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.