ECTDP: Effects of Convective Therapies in Dialysis Patients

• Sponsor: A. Manzoni Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01583309
• Collaborator: (none)
• Enrollment: 146
• Locations: 27
• Arms: 3
• Duration (Months): 51
• Patients Per Site: 5.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uremia	Procedure: online pre-dilution hemofiltration; Procedure: online pre-dilution hemodiafiltration	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 146 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects of Convective Therapies in Dialysis Patients
• Study Start Date: Nov 1, 2003
• Actual Primary Completion Date: Feb 1, 2008
• Actual Study Completion Date: Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: low-flux hemodialysis
Experimental: online pre-dilution hemofiltration	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; Other Names: online pre-dilution hemofiltration Technique
Experimental: online pre-dilution hemodiafiltration	Procedure: 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.; Other Names: online pre-dilution hemodiafiltration Technique

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

2. Calcium-phosphate metabolism [Monthly for 2 years]

   Outcome measures: phosphatemia, calcemia and PTH

3. Beta2 microglobulin [Every six months for 2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale S.Marta S.Venera	Acireale (CT)		Italy
2	Ospedale F. Miulli	Acquaviva delle Fonti		Italy
3	Ospedale Civile	Alghero		Italy
4	Ospedale regionale di Aosta	Aosta		Italy
5	Ospedale degli Infermi	Biella		Italy
6	Ospedale SS. Trinità ASL 8	Cagliari		Italy
7	S. Michele Hospital	Cagliari		Italy
8	Ospedale Civile "P. Merlo"	La maddalena		Italy
9	Alessandro Manzoni Hospital	Lecco		Italy
10	Ospedale "C. POMA"	Mantova		Italy
11	T. EVOLI	Melito Porto Salvo		Italy
12	Ospedale dell'Angelo	Mestre		Italy
13	Policlinico Multimedica IRCCS	Milano		Italy
14	Federico II	Napoli		Italy
15	Ospedale San Francesco	Nuoro		Italy
16	San Giovanni di Dio	Olbia		Italy
17	Ospedale Antonio Segni	Ozieri		Italy
18	Ospedale Maggiore	Parma		Italy
19	Fondazione Maugeri	Pavia		Italy
20	Ospedale " E. AGNELLI "	Pinerolo		Italy
21	Dipartimento territoriale ASL 8	Quartu Sant'Elena		Italy
22	Ospedale S.Maria delle Croci	Ravenna		Italy
23	Azienda Ospedaliera "Bianchi Melacrino Morelli,"	Reggio Calabria		Italy
24	Ospedale Bolognini	Seriate		Italy
25	Ospedale Agostino Landolfi	Solofra		Italy
26	Ospedale San Camillo	Sorgono		Italy
27	ASL 2 Olbia - P.O. "P. Dettori",	Tempio Pausania		Italy

Sponsors and Collaborators

• A. Manzoni Hospital

Investigators

• Study Chair: Francesco Locatelli, Professor, A. Manzoni Hospital, Lecco - Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Prof. Francesco Locatelli, Professor Francesco Locatelli, A. Manzoni Hospital
• ClinicalTrials.gov Identifier: NCT01583309
• Other Study ID Numbers: CONVESTUDY
• First Posted: Apr 24, 2012
• Last Update Posted: Apr 24, 2012
• Last Verified: Apr 1, 2012

• Keywords provided by Prof. Francesco Locatelli, Professor Francesco Locatelli, A. Manzoni Hospital: blood pressure; cardiovascular instability; symptomatic hypotension; online hemofiltration; online hemodiafiltration
• Additional relevant MeSH terms: Uremia

Study Results

No Results Posted as of Apr 24, 2012