Ultrafiltration Versus Medical Therapies in the Management of the Cardio Renal Syndrome (UF-CARE)

Civil Hospices of Lyon

Status: Unknown

Conditions: Cardio-renal Syndrome

Treatments: Procedure: ULTRAFILTRATION; Procedure: ENHANCED MEDICAL TREATMENT

Study type: Interventional

Funder types: Other

Identifiers

NCT02846337

2016-A00518-43 (Other Identifier)

69HCL15_0077

Details and patient eligibility

About

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.

Enrollment: 154 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 2 patient groups

ULTRAFILTRATION

Experimental group

Description:

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

Treatment:

Procedure: ULTRAFILTRATION

ENHANCED MEDICAL TREATMENT

Other group

Description:

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.

Treatment:

Procedure: ENHANCED MEDICAL TREATMENT