Effects of Convective Therapies in Dialysis Patients

Uremia Clinical Trial

— ECTDP  

Official title:

Effects of Convective Therapies in Dialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01583309
• Other study ID #: CONVESTUDY
• Status: Completed
• Phase: Phase 3
• First received: April 17, 2012
• Last updated: April 23, 2012
• Start date: November 2003
• Est. completion date: February 2008

Study information

• Verified date: April 2012
• Source: A. Manzoni Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Uremia

Intervention

Procedure:
• online pre-dilution hemofiltration
Online pre-dilution hemofiltration was performed with a synthetic high-flux membrane and an infusate/blood flow ratio of one
• online pre-dilution hemodiafiltration
Online pre-dilution hemodiafiltration was performed with a synthetic high-flux membrane with an infusate/blood flow ratio of 0.6 and a dialysate plus infusate rate of 700 ml/min.

Locations

Country	Name	City	State
Italy	Ospedale S.Marta S.Venera	Acireale (CT)
Italy	Ospedale F. Miulli	Acquaviva delle Fonti
Italy	Ospedale Civile	Alghero
Italy	Ospedale regionale di Aosta	Aosta
Italy	Ospedale degli Infermi	Biella
Italy	Ospedale SS. Trinità ASL 8	Cagliari
Italy	S. Michele Hospital	Cagliari
Italy	Ospedale Civile "P. Merlo"	La maddalena
Italy	Alessandro Manzoni Hospital	Lecco
Italy	Ospedale "C. POMA"	Mantova
Italy	T. EVOLI	Melito Porto Salvo
Italy	Ospedale dell'Angelo	Mestre
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 Bolognini	Seriate
Italy	Ospedale Agostino Landolfi	Solofra
Italy	Ospedale San Camillo	Sorgono
Italy	ASL 2 Olbia - P.O. "P. Dettori",	Tempio Pausania

Sponsors (1)

Lead Sponsor	Collaborator
A. Manzoni Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Bolasco P, Altieri P, Andrulli S, Basile C, Di Filippo S, Feriani M, Pedrini L, Santoro A, Zoccali C, Sau G, Locatelli F. Convection versus diffusion in dialysis: an Italian prospective multicentre study. Nephrol Dial Transplant. 2003 Aug;18 Suppl 7:vii50-4; discussion vii59-62. — View Citation

Locatelli F, Altieri P, Andrulli S, Bolasco P, Sau G, Pedrini LA, Basile C, David S, Feriani M, Montagna G, Di Iorio BR, Memoli B, Cravero R, Battaglia G, Zoccali C. Hemofiltration and hemodiafiltration reduce intradialytic hypotension in ESRD. J Am Soc N — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intradialytic symptomatic hypotension	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	all dialysis sessions, three per week, for 2 years	No
Secondary	Resistance to erythropoiesis-stimulating agents	Resistance to erythropoiesis-stimulating agents was measured as (EPO therapy in IU/week)/(Hb in g/dL*body wheight in kg)	Monthly for 2 years	No
Secondary	Calcium-phosphate metabolism	Outcome measures: phosphatemia, calcemia and PTH	Monthly for 2 years	No
Secondary	Beta2 microglobulin		Every six months for 2 years	No