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

NCT ID: NCT02846337

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-31
• Study Completion Date: 2021-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

ULTRAFILTRATION

The ultrafiltration sodium-overload extraction will be chosen by the patient nephrologist and the patient himself (according to his comorbidities) among the following one: peritoneal dialysis (at least a daily contact), hemodialysis (\>1 session per week) or isolated ultrafiltration (\>1 session per week). Ultrafiltration technique could change throughout the care

Group Type: EXPERIMENTAL

ULTRAFILTRATION

Intervention Type: PROCEDURE

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.

ENHANCED MEDICAL TREATMENT

The control group called "enhanced medical treatment" will not benefit of ultrafiltration (except refractory pulmonary edema, or terminal kidney failure requiring extra renal depuration). These situations will not be considered as protocol violation, because they are scientifically indicated for extra renal depuration.

Group Type: OTHER

ENHANCED MEDICAL TREATMENT

Intervention Type: PROCEDURE

• 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Severe heart failure with recurring congestive symptoms and at least one the following criteria :

• At least 2 hospitalization > 24 hours for congestive symptoms among the 12 months before the inclusion, whose latest one was in the 6 months before the inclusion
• Persistent congestive symptoms throughout 30 days (case history) before the randomization: dyspnea NYHA III or IV, lower limbs edema and/or ascites.
• Diuretic treatment with at least 250mg furosemide per day (or 6mg bumetanide)during at least 1 month
• Cardiac medical treatment enhanced by the European cardiology society guidance (except intolerance, and/or contraindication) and according to patient cardiologist.
• Non terminal kidney disease or failure : estimated glomerular filtration rate (GFR) (CKD-Epi formula) between 20 and 90 mL/min/1.73m² (or GFR estimated between 60 and 90 mL/min/1.73m² with proteinuria and/or hematuria) and urea rate under 50mmol/L

Exclusion Criteria

• Cardiogenic shock or situations that contraindicate the ultrafiltration technique elsewhere than shock room
• Patient who already had long course ultrafiltration for more than 3 months, or not available because of end-stage renal failure
• Biventricular pacemaker implementation, single or dual chamber pacemaker implementation, or defibrillator implementation up to 15 days before the inclusion
• Vasoactive drugs ambulatory treatment (dobutamine, dopamine, adrenalin, noradrenalin)
• General condition incompatible with any ultrafiltration techniques
• Age under 18
• Pregnant or lactating women
• Law-protected patients
• Patients that can't submit to the follow-up for geographical, social or mental reasons
• Unwillingness to be treated by ultrafiltration techniques
• Patients who don't belong to the national social security system, or similar system.

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

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent JUILLARD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon, 69002 LYON France

Locations

Hospices Civils de Lyon, Hôpital E Herriot, Service de néphrologie, 5 place d'Arsonval

Lyon, Rhones Alpes, France

Site Status: RECRUITING

Countries

France

Central Contacts

Laurent JUILLARD, Pr

Role: CONTACT

laurent.juillard@chu-lyon.fr

(0)472 110 159 ext. +33

Laurent MAGAUD

Role: CONTACT

laurent.magaud@chu-lyon.fr

(0)472 112 805 ext. +33

Facility Contacts

Laurent JUILLARD, Pr

Role: primary

laurent.juillard@chu-lyon.fr

(0)472 110 159 ext. +33

Laurent MAGAUD

Role: backup

laurent.magaud@chu-lyon.fr

(0)472 112 805 ext. +33

Other Identifiers

2016-A00518-43

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL15_0077

Identifier Type: -

Identifier Source: org_study_id