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Search / Trial NCT06896786

This Study Evaluates the Impact of the Sodium Management Tool (SMT) on Hemodialysis Patient Outcomes Compared to Standard Care

Launched by SHARON-ROSE MALONEY · Mar 19, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Sodium Management In Hemodialyis Patients Management Of Complaints In Hemodialysis Patients Interdialytic Weight Gain Intradialytic Hypotension Sodium Management Tool

ClinConnect Summary

This clinical trial is studying whether a new tool called the Sodium Management Tool (SMT) can improve the health and comfort of patients receiving hemodialysis. The researchers want to find out if using the SMT can help reduce weight gain between dialysis sessions and make dialysis easier by lowering symptoms like low blood pressure and muscle cramps. To do this, they will compare the usual dialysis treatment with the SMT-assisted treatment.

Eligible participants are adults aged 18 and older who have been on hemodialysis for at least three months and receive dialysis three times a week using a specific machine. During the study, participants will switch between standard dialysis and SMT-assisted dialysis every four weeks. They will have their blood pressure and sodium levels monitored, and they will answer questions about their symptoms and how thirsty they feel. This trial aims to see if the SMT can help patients feel better during their treatments and improve their overall health.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Outpatients on hemodialysis for at least three months,
  • Dialysis three times a week, age \>/= 18,
  • dialysis with a Fresenius 6008 Machine,
  • signed informed consent
  • Exclusion:
  • Dialysis access with repeated Interruption due to flow problems
  • plasma natrium \< 130 mmol/l, \> 145 mmol/l, pregnancy -

About Sharon Rose Maloney

Sharon-Rose Maloney is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and improving patient outcomes. With a focus on innovative therapies and evidence-based practices, she collaborates with leading researchers and healthcare professionals to design and implement robust clinical trials. Sharon-Rose emphasizes ethical standards and regulatory compliance, ensuring that all studies prioritize participant safety and data integrity. Her expertise in trial management and patient engagement reflects a deep understanding of the complexities of clinical research, making her a key player in the development of new treatments and therapies.

Locations

Patients applied

0 patients applied

Trial Officials

Balthasar Hug, Professor

Principal Investigator

LUKS Luzern

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported