NCT01353170

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2011

Completed
Last Updated

May 12, 2011

Status Verified

December 1, 2010

Enrollment Period

8 months

First QC Date

May 9, 2011

Last Update Submit

May 11, 2011

Conditions

Calcium Mass Balances and Serum Calcium Profiling in hd Patients

Keywords

Serum calciumDialysateMass balanceBlood pressure

Outcome Measures

Primary Outcomes (1)

  • Serum calcium concentrations

    Evaluation of calcium mass balances and ionized calcium serum concentrations profiling during three hd sessions with different calcium concentrations in the dialysate

    4 hours

Study Arms (1)

Prevalent hd patients

EXPERIMENTAL

Patients undergoing three consecutive cross-over hd session with 3 different dialysate calcium concentrations

Other: Dialysate calcium concentration

Interventions

Dialysate calcium concentrationOTHER

Calcium dialysate concentrations: 1.25, 1.35 and 1.5 mmol/l

Prevalent hd patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • bicarbonate hd since 6 months
  • uncomplicated hd sessions

You may not qualify if:

  • Incident patients
  • unstable hd patients
  • patients aged less than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nephrology and dialysis unit Miulli General Hospital

Acquaviva delle Fonti, Bari, 70100, Italy

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 9, 2011

First Posted

May 12, 2011

Study Start

January 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

May 12, 2011

Record last verified: 2010-12

Locations

IT(1)