Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01583309
Other study ID # CONVESTUDY
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT00577967 - Gabapentin - A Solution to Uremic Pruritus? N/A
Completed NCT03437538 - Reduction Ratio and Clearance During Hemodialysis With MCO-filter Compared to HDF With Standard High-flux Filter N/A
Completed NCT00649298 - A Clinical Trial of IntensiVE Dialysis Phase 4
Completed NCT05750875 - Gabapentin Versus Loratadine in Uremic Pruritus Phase 4
Recruiting NCT01408797 - Clonal Deletion on Living-Relative Donor Kidney Transplantation Phase 1/Phase 2
Completed NCT01267760 - Clinical and Biochemical Effects of Multipass Hemodialysis Phase 2
Recruiting NCT00375635 - Removal of Protein Bound Uremic Toxins by Modified Plasma Separation and Adsorption Combined With Hemodialysis N/A
Recruiting NCT05076318 - Dysregulated Urea-synthesis at Terminal Uremia N/A
Completed NCT05899283 - A Comparative Study of Two Kinds of Hemodialysis Filters N/A
Completed NCT04768309 - Impact of Intestinal Microbiota on Uremic Toxins Productions N/A
Not yet recruiting NCT05386433 - Paxlovid in the Treatment of COVID-19 Patients With Uremia Early Phase 1
Completed NCT01391884 - Elimination of Incretin Hormones in Patients With Severe Kidney Failure N/A
Completed NCT00442819 - Uremic Pruritus, Cytokines and Polymethylmethacrylate Artificial Kidney Phase 4
Not yet recruiting NCT02266238 - Stenosis of Arteria-Venous Fistula in Maintenance Hemodialysis Patients: Early Intervention Trial N/A
Recruiting NCT01766895 - Long-term Follow Up of Viral Hepatitis in Uremic Patients in Taiwan
Completed NCT00388648 - Very Low Protein Diet or Dialysis in Uremic Elderly? Phase 4
Withdrawn NCT03416192 - 12 Weeks of Hemodialysis With Medium Cut-Off Filter Compared to Hemodiafiltration With Standard High-flux Filter. N/A
Recruiting NCT02606955 - Probing the Dry Weight by Bioimpedance: The Resistance Stabilization Test N/A
Recruiting NCT02446535 - Probing the Dry Weight (DW) by Bioimpedance (BIA): Which is the Gold Standard Between Clinical DW and BIA DW? N/A
Completed NCT02050139 - L-Cysteine in Peritoneal Dialysis Phase 2