Effects of Convective Therapies in Dialysis Patients

Phase 3

Completed

• Conditions: Uremia
• Interventions: Procedure: online pre-dilution hemodiafiltration; Procedure: online pre-dilution hemofiltration

• Registration Number: NCT01583309
• Lead Sponsor: A. Manzoni Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2012-04
• Study First Submitted: 2012-04-17
• Study First Submitted QC: 2012-04-23
• Last Update Submitted: 2012-04-23
• Study First Posted: 2012-04-24
• Last Update Posted: 2012-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
online pre-dilution hemodiafiltration	online pre-dilution hemodiafiltration	-
online pre-dilution hemofiltration	online pre-dilution hemofiltration	-

Primary Outcome Measures

Name	Time	Method
Intradialytic symptomatic hypotension	all dialysis sessions, three per week, for 2 years	Intradialytic symptomatic hypotension was defined as a rapid symptomatic fall of the systolic blood pressure by at least 30 mmHg or that required nursing and/or medical intervention

Secondary Outcome Measures

Name	Time	Method
Resistance to erythropoiesis-stimulating agents	Monthly for 2 years	Resistance to erythropoiesis-stimulating agents was measured as (EPO therapy in IU/week)/(Hb in g/dL\*body wheight in kg)
Calcium-phosphate metabolism	Monthly for 2 years	Outcome measures: phosphatemia, calcemia and PTH
Beta2 microglobulin	Every six months for 2 years

Trial Locations

Locations (27)

Ospedale Civile "P. Merlo"; 🇮🇹 La maddalena, Italy

T. EVOLI; 🇮🇹 Melito Porto Salvo, Italy

Ospedale dell'Angelo; 🇮🇹 Mestre, Italy

Ospedale "C. POMA"; 🇮🇹 Mantova, Italy

Ospedale Civile; 🇮🇹 Alghero, Italy

Ospedale S.Marta S.Venera; 🇮🇹 Acireale (CT), Italy

Ospedale F. Miulli; 🇮🇹 Acquaviva delle Fonti, Italy

Ospedale regionale di Aosta; 🇮🇹 Aosta, Italy

Ospedale degli Infermi; 🇮🇹 Biella, Italy

Ospedale SS. Trinità ASL 8; 🇮🇹 Cagliari, Italy

S. Michele Hospital; 🇮🇹 Cagliari, Italy

Alessandro Manzoni Hospital; 🇮🇹 Lecco, Italy

ASL 2 Olbia - P.O. "P. Dettori",; 🇮🇹 Tempio Pausania, Italy

Policlinico Multimedica IRCCS; 🇮🇹 Milano, Italy

Federico II; 🇮🇹 Napoli, Italy

Ospedale San Francesco; 🇮🇹 Nuoro, Italy

San Giovanni di Dio; 🇮🇹 Olbia, Italy

Ospedale Antonio Segni; 🇮🇹 Ozieri, Italy

Ospedale Maggiore; 🇮🇹 Parma, Italy

Fondazione Maugeri; 🇮🇹 Pavia, Italy

Ospedale " E. AGNELLI "; 🇮🇹 Pinerolo, Italy

Dipartimento territoriale ASL 8; 🇮🇹 Quartu Sant'Elena, Italy

Ospedale S.Maria delle Croci; 🇮🇹 Ravenna, Italy

Azienda Ospedaliera "Bianchi Melacrino Morelli,"; 🇮🇹 Reggio Calabria, Italy

Ospedale Agostino Landolfi; 🇮🇹 Solofra, Italy

Ospedale Bolognini; 🇮🇹 Seriate, Italy

Ospedale San Camillo; 🇮🇹 Sorgono, Italy