Effects of Convective Therapies in Dialysis Patients (ECTDP)

A. Manzoni Hospital

Status and phase: Completed; Phase 3

Conditions: Uremia

Treatments: Procedure: online pre-dilution hemofiltration; Procedure: online pre-dilution hemodiafiltration

Study type: Interventional

Funder types: Other

Identifiers

NCT01583309

CONVESTUDY

Details and patient eligibility

About

Convective therapies have been proposed for improving chronic dialysis patient outcomes, including intradialytic symptomatic hypotension.

To evaluate the frequency of sessions with intradialytic symptomatic hypotension in different types and doses of convective therapies compared with low-flux hemodialysis (HD), the investigators performed a multicentre, open-label, randomized controlled trial.

Enrollment: 146 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Dialysis patients aged 18-80 years
• thrice-weekly HD or HDF for at least 6 months
• body weight less or equal to 90 Kg
• stable clinical condition
• written consent

Exclusion criteria

• infections
• malignancies
• active systemic diseases
• active hepatitis or cirrhosis
• unstable diabetes
• diuresis higher than 200 ml/24h
• dysfunction of vascular access
• blood flow rate less than 300 ml/min

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 3 patient groups

low-flux hemodialysis

No Intervention group

online pre-dilution hemofiltration

Experimental group

Treatment:

Procedure: online pre-dilution hemofiltration

online pre-dilution hemodiafiltration

Experimental group

Treatment:

Procedure: online pre-dilution hemodiafiltration