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Completed

NCT Number: NCT01583309

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.

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Key information

Conditions

Uremia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ospedale S.Marta S.Venera, Acireale (CT), Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

online pre-dilution hemofiltration

Procedure

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

online pre-dilution hemodiafiltration

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. Calcium-phosphate metabolism

    Time frame: Monthly for 2 years

    Outcome measures: phosphatemia, calcemia and PTH

  3. Beta2 microglobulin

    Time frame: Every six months for 2 years

Sponsors and collaborators

Lead sponsor

A. Manzoni Hospital

Other

Registry information

Acronym: ECTDP

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Apr 24, 2012
Registry last updated
Apr 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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