Calcium Concentration in Bicarbonate Hemodialysis (HD)

This study has been completed.
Sponsor:
Information provided by:
Miulli General Hospital
ClinicalTrials.gov Identifier:
NCT01353170
First received: May 9, 2011
Last updated: May 11, 2011
Last verified: December 2010
  Purpose

The study was designed in order to investigate the effects of 3 different dialysate calcium concentrations may exert on mineral metabolism and hemodynamic stability in standard hemodialysis (hd).


Condition Intervention
Calcium Mass Balances and Serum Calcium Profiling in hd Patients
Other: Dialysate calcium concentration

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison Among Different Dialysate Calcium Concentrations in Bicarbonate Hemodialysis

Resource links provided by NLM:


Further study details as provided by Miulli General Hospital:

Primary Outcome Measures:
  • Serum calcium concentrations [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    Evaluation of calcium mass balances and ionized calcium serum concentrations profiling during three hd sessions with different calcium concentrations in the dialysate


Enrollment: 22
Study Start Date: January 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prevalent hd patients
Patients undergoing three consecutive cross-over hd session with 3 different dialysate calcium concentrations
Other: Dialysate calcium concentration
Calcium dialysate concentrations: 1.25, 1.35 and 1.5 mmol/l

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • bicarbonate hd since 6 months
  • uncomplicated hd sessions

Exclusion Criteria:

  • Incident patients
  • unstable hd patients
  • patients aged less than 18 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353170

Locations
Italy
Nephrology and dialysis unit Miulli General Hospital
Acquaviva delle Fonti, Bari, Italy, 70100
Sponsors and Collaborators
Miulli General Hospital
  More Information

No publications provided

Responsible Party: Carlo Basile M D, Miulli GH
ClinicalTrials.gov Identifier: NCT01353170     History of Changes
Other Study ID Numbers: Basile calcium
Study First Received: May 9, 2011
Last Updated: May 11, 2011
Health Authority: Italy: diocesi di Bari

Keywords provided by Miulli General Hospital:
Serum calcium
Dialysate
Mass balance
Blood pressure

Additional relevant MeSH terms:
Calcium, Dietary
Dialysis Solutions
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Pharmaceutical Solutions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014