NCT02846337

Ultrafiltration Versus Medical Therapies in the Management of the Cardio Renal Syndrome

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Type 2 cardio renal syndrome is defined by the occurrence or the exacerbation of a kidney failure induced by a chronic heart failure. Sodium overload is one of the main causes leading to the occurrence or the exacerbation of this syndrome. Some patients have a massive sodium retention on which medications are not effective enough. These patients have no further therapeutic options because of the refractory congestion and a 3-months mortality rate around 15%, frequent rehospitalization (3-months rehospitalization rate at 71%) and an excessively impaired quality of life. For those refractory heart failure with cardio renal syndrome, nephrology departments resort to non-medication sodium extraction (hemodialysis, peritoneal dialysis, isolated ultrafiltration). Between 2002 and 2008, 927 French patients would have start dialysis in this situation. In 2013, 174 patients start dialysis in 97 dialysis centers. French National Authority of Health recently published new Good Practice Guidance thereupon, strengthened by the increasing number of publications and the widespread use of this technique. There is therefore a consensus among professionals about the benefits of such a technique in those indications. However, bibliographical data are not strong enough to support a strong level of evidence. None of foresight strategies have been compared to others in a proper randomized controlled trial, and there is no clue about any suspected superiority from one strategy to another. So far, the investigators propound invasive, expensive and not validated techniques to patients with functional and vital prognosis altered. The investigators think it's essential to prove the efficacy of such an approach. They wish to quantify those techniques impact on rehospitalization, with a consideration for the potential survival impact. It seems unethical to evaluate separated techniques, taking in account that patients with severe heart failure will switch from one technique to another among their care. It is therefore crucial to validate benefits from an invasive procedure (hemodialysis, peritoneal dialysis, isolated ultrafiltration) compared to a medication-restricted care.

Conditions

• Cardio-renal Syndrome

Interventions

Type	Name	Description
PROCEDURE	ULTRAFILTRATION	Peritoneal dialysis: at least one daily contact, 5 days a week minimum, with a hypertonic solution. Le number of contact et the stasis duration will be decided by the practitioner. Hemodialysis: at least one hemodialysis per week, one hemofiltration and/or hemodiafiltration per week, and at least 2 liter of ultrafiltrate extraction per week. In case of serious interdialytic weight gain, and/or hemodynamic unsteadiness, sessions can be up to 6 per weeks. Sessions duration will be adjusted to the needful ultrafiltrate and hemodynamic tolerance. Isolated ultrafiltration: at least once a week, and includes an extraction of minimum 2 liter ultrafiltrate in less than 4 hours. It could be done, according to routines and department capacity, on a hemodialysis generator, plasmatic exchange generator, or mobile ultrafiltration device.
PROCEDURE	ENHANCED MEDICAL TREATMENT	* Close cardiologic and nephrologic follow-up, minimum 4 times a year, This incidence matches the heart failure, and chronic kidney failure care guidance for our sample * Medical care adjustment in order to apply European and American guidance for chronic heart failure care * Hydric, caloric, peptic and sodium input evaluation by a dietician, and adjustment if needed * Physical rehabilitation suggestions by a physiologist * Evaluation of an interventional approach requirement, and implementation if needed (pacemaker, defibrillator, cardiac resynchronization, diagnosis and therapeutic coronary angiography, ventricular stimulator) according to European and American guidance.

Timeline

• Start date: 2017-03-31
• Primary completion: 2021-09-30
• Completion: 2021-09-30
• First posted: 2016-07-27
• Last updated: 2018-10-09

Locations

1 site across 1 country: France