Effect of Sodium and UF Profiling on Dialysis

NCT ID: NCT06213129

Last Updated: 2024-01-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2024-08-28

Brief Summary

The aim of this study is to evaluate the effects of sodium and UF profiling on hemodynamic stability, interdialytic weight gain, and intradialytic complications

Detailed Description

Sodium and ultrafiltration profiling are method of dialysis in which dialysate sodium concentration and ultrafiltration rate are altered during the course of the dialysis session.

Several sodium profiling methods are available. Increasing, decreasing, or alternating sodium concentrations may be used, although decreasing profiling has been the most accepted. The decrease in dialysate sodium concentration may be linear, stepwise, or exponential As different sodium profiling methods may have distinct impacts, different dialysis modalities may also affect the outcome of profiling. Although not as commonly used, hemodiafiltration HDF which utilizes convective clearance in addition to diffusion, may change the results of sodium profiling Such intervention alleviates the acute decline in intravascular volume during ultrafiltration UF as well as the decline in intradialytic plasma osmolarity and the consequent disequilibrium syndrome Sodium profiling enhances the internal plasma refill rate and helps to stabilize the blood pressure, thus decreasing the risk of Intra dialytic hypotension. It is imperative to limit or prevent intradialytic hypotension since it does not only affect the patient's comfort but also increases the risk of vascular access thrombosis, myocardial fibrosis and stunning, cardiovascular events, and mortality So it has potential benefits in terms of intradialytic morbidity and mortality as well as quality of life and long-term cardiovascular events; nevertheless, it may also predispose to interdialytic hypernatremia and increased interdialytic hypernatremia and interdialytic weight gain IDWG and hypertension. Fatigue and thirst have been reported with sodium profiling and the resulting sodium overload.

Another method to avoid intradialytic hemodynamic instability is UF profiling. In it, a larger portion of total UF volume is extracted during the first part of a dialysis session, after which the UF rate is decreased in order to maintain hemodynamic stability However, achieving a correct intradialytic sodium balance is a much more difficult task in clinical practice. With the advances in technology, automatic computer-based programs can be used today to calculate intradialytic sodium removal. These models use real-time data from patients and are being used to reach underdialysis sodium, weight in Kg, and blood volume targets. Such biofeedback systems enable to achieve sodium balance neutral sodium profile and UF profile automatically. Currently, there are various commercial dialysis systems that calculate dialysate and UF profiles with algorithms based on the prescribed decrease in body weight and sodium mass.

The aim of study to determine which specific profiling methods is more efficacious in preventing specific symptoms and which profiling method has the most utility in routine clinical practice. Furthermore, more qualitative data is warranted for subjective analysis of quality of life and personal well-being.

Conditions

Dialysis; Complications

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Interventions

Na and ultrafiltration profiling

Sodium and ultrafiltration profiling are method of dialysis in which dialysate sodium concentration and ultrafiltration rate are altered during the course of the dialysis session

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• End-stage renal disease patients.
• Patients on regular hemodialysis

Exclusion Criteria

• Patients who refuse to contribute in this study.
• Hemodynamically unstable patients.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Neveen Hassan

MA Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

youssef Saleh

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Neveen Hassan

Role: CONTACT

nivoh86@gmail.com

01069309948

Ragda Hassan, 3

Role: CONTACT

+20 106 482 4351

References

Coli L, La Manna G, Dalmastri V, De Pascalis A, Pace G, Santese G, Stefanio C, Ursino M, Zaca F, Stefoni S. Evidence of profiled hemodialysis efficacy in the treatment of intradialytic hypotension. Int J Artif Organs. 1998 Jul;21(7):398-402.

Reference Type: BACKGROUND

PMID: 9745994 (View on PubMed)

Other Identifiers

Na and UF profiling on ESRD

Identifier Type: -

Identifier Source: org_study_id