NCT07413315 Benefits of a Renal Rehabilitation Program Adapted to Uremic Patients on Daily Hemodialysis at Low Dialysate Flow Rate.
| NCT ID | NCT07413315 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Brugmann University Hospital |
| Condition | Chronic Kidney Disease Requiring Hemodialysis |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-08-13 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-08-13 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The concept of renal rehabilitation has become increasingly important with the increasing age of patients with severe or even terminal chronic kidney disease (CKD). It combines physical exercise and nutritional monitoring programs for patients with terminal CKD who are most often treated with conventional hemodialysis (HD) at a rate of 3 sessions of 4 hours per week. Sarcopenia is a very common phenomenon in patients with CKD. The prevalence found in recent meta-analyses varies between 25.6 and 28.5% in patients treated with dialysis. It is even higher in patients treated with HD than in patients treated with peritoneal dialysis (PD). Younger and more active patients will more often choose PD. The conventional HD modality preserves residual renal function less well, which is important for better elimination of uremic toxins bound to plasma proteins. Conventional HD requires a higher immobilization time and causes more post-dialysis symptoms, leaving less time for the patient to be physically active. The phenomenon of sarcopenia is not insignificant. It is associated in dialysis patients with a higher mortality rate (risk x 1.8) and a higher incidence of cardiovascular events (risk x 3.8). The association with higher mortality is well demonstrated for the 2 main components of sarcopenia, namely reduced muscle mass and reduced muscle strength. Sarcopenia also increases the risk of falls and fractures, it decreases the physical performance of patients and their ability to perform activities of daily living. The quality of life of patients is reduced and the probability of social placement is high. The phenomena of sarcopenia and physical deconditioning are even more problematic in patients in HD after an acute medical problem. The need for rehabilitation is even higher. "Classical" HD treatment can be a burden for these patients, leaving no room for integrating a complete rehabilitation program. Daily low dialysate flow rate hemodialysis (LDF) is a type of hemodialysis in which patients benefit from more frequent but shorter and hemodynamically better tolerated HD sessions. This new technique potentially presents certain advantages over conventional HD, particularly at the cardiovascular level: better blood pressure control and better reduction of left ventricular hypertrophy. LDF also allows better control of hyperphosphatemia with a reduced need for phosphorus binders. Thanks to more frequent dialysis (5 to 6 sessions per week), inter-dialytic weight gain is often less significant, allowing less aggressive ultrafiltration, with better hemodynamic tolerance, and better post-dialysis recovery. In this perspective, this study aims to examine the interest of integrating HDQ dialysis into a renal rehabilitation program in patients with terminal CKD whose dialysis must continue after an acute event requiring hospitalization. The investigators want to study whether this technique allows the implementation of a more effective rehabilitation program, while maintaining the same dialysis efficiency as with the conventional HD technique. To the investigator's knowledge, no study concerning patients under HDQ has been conducted during their renal rehabilitation phase. The objectives of the current study are: * To study the interest of integrating HDQ dialysis into a renal rehabilitation program in patients with terminal CKD. * To study the efficacy and tolerance of HDQ dialysis and the rehabilitation program in these patients.
Eligibility Criteria
Inclusion Criteria: * patient with terminal chronic kidney disease requiring hemodialysis treatment * patient recently hospitalized for an acute medical event. Exclusion Criteria: * dementia/mild cognitive impairment (MMSE \< 20/30) * decompensated psychiatric pathology and/or behavioral disorders * pregnant woman * recovery of renal function allowing interruption of helodialysis sessions * candidate for neurological rehabilitation * patient with recent spinal cord injury * patient with absolute and/or relative contraindication to performing a stress test * severe or poorly tolerated cardiac rhythm disorder * severe or symptomatic obstruction to left ventricular ejection * decompensated heart failure * acute myocarditis, pericarditis or endocarditis * acute aortic dissection * high-risk emboligenic intracardiac thrombus * significant stenosis of the common trunk * ventricular aneurysm * supraventricular tachycardia with poorly controlled ventricular rate, acquired high-degree or complete block * obstructive cardiomyopathy with high resting gradient * recent stroke or TIA * acute venous thrombosis with or without pulmonary embolism * poorly controlled clinical condition, such as marked anemia, significant electrolyte disturbance, hyperthyroidism, etc. * lack of cooperation from the patient * Blood pressure \> 200/110 mmHg
Contact & Investigator
Joris Vanparys, MD
PRINCIPAL INVESTIGATOR
CHU Brugmann
Frequently Asked Questions
Who can join the NCT07413315 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Kidney Disease Requiring Hemodialysis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07413315 currently recruiting?
Yes, NCT07413315 is actively recruiting participants. Contact the research team at Joris.VANPARYS@chu-brugmann.be for enrollment information.
Where is the NCT07413315 trial being conducted?
This trial is being conducted at Brussels, Belgium.
Who is sponsoring the NCT07413315 clinical trial?
NCT07413315 is sponsored by Brugmann University Hospital. The principal investigator is Joris Vanparys, MD at CHU Brugmann. The trial plans to enroll 50 participants.
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