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Effects of Convective Therapies in Dialysis Patients (ECTDP)

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ClinicalTrials.gov Identifier: NCT01583309
Recruitment Status : Completed
First Posted : April 24, 2012
Last Update Posted : April 24, 2012
Sponsor:
Information provided by (Responsible Party):
Prof. Francesco Locatelli, A. Manzoni Hospital

April 17, 2012
April 24, 2012
April 24, 2012
November 2003
February 2008   (Final data collection date for primary outcome measure)
Intradialytic symptomatic hypotension [ Time Frame: 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
Same as current
No Changes Posted
  • Resistance to erythropoiesis-stimulating agents [ Time Frame: 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 [ Time Frame: Monthly for 2 years ]
    Outcome measures: phosphatemia, calcemia and PTH
  • Beta2 microglobulin [ Time Frame: Every six months for 2 years ]
Same as current
Not Provided
Not Provided
 
Effects of Convective Therapies in Dialysis Patients
Effects of Convective Therapies in Dialysis Patients

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Uremia
  • 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 Name: online pre-dilution hemofiltration Technique
  • 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 Name: online pre-dilution hemodiafiltration Technique
  • No Intervention: low-flux hemodialysis
  • Experimental: online pre-dilution hemofiltration
    Intervention: Procedure: online pre-dilution hemofiltration
  • Experimental: online pre-dilution hemodiafiltration
    Intervention: Procedure: online pre-dilution hemodiafiltration

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
146
Same as current
February 2008
February 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01583309
CONVESTUDY
No
Not Provided
Not Provided
Prof. Francesco Locatelli, A. Manzoni Hospital
A. Manzoni Hospital
Not Provided
Study Chair: Francesco Locatelli, Professor A. Manzoni Hospital, Lecco - Italy
A. Manzoni Hospital
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP