NCT00237783

Brief Summary

Low blood pressure (hypotension) during dialysis afflicts approximately 25% of hemodialysis patients. In this pilot study, we will evaluate the safety and effects of individualizing the sodium concentration in the dialysate according to the patient's own plasma sodium levels. We hypothesize that patients will have less thirst and less weight gain during the intervention leading to easier fluid removal and less episodes of hypotension.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

3 years

First QC Date

October 7, 2005

Last Update Submit

July 25, 2016

Conditions

HemodialysisHypotension

Keywords

Renal dialysisHypotensionDialysis solutions

Outcome Measures

Primary Outcomes (1)

  • Intradialytic BP change

    from study onset through intervention, week 7

Secondary Outcomes (3)

  • Intradialytic changes in cardiac output and peripheral vascular resistance

    from study onset through intervention, week 7

  • Interdialytic weight gain change

    from study onset through intervention, week 7

  • Thirst scores

    from study onset through intervention, week 7

Study Arms (2)

standard dialysate sodium (140 mmol/L)

ACTIVE COMPARATOR

dialysate sodium (140 mmol/L)

Drug: dialysate sodium (140 mmol/L)

individualized dialysate sodium

EXPERIMENTAL

individualized dialysate sodium (same concentration as the average pre-HD serum sodium during the baseline period)

Drug: individualized dialysate sodium

Interventions

dialysate sodium (140 mmol/L)DRUG
standard dialysate sodium (140 mmol/L)
individualized dialysate sodiumDRUG

individualized dialysate sodium (same concentration as the average pre-HD serum sodium during the baseline period)

individualized dialysate sodium

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hemodialysis patients with intradialytic hypotension

You may not qualify if:

  • Atrial fibrillation
  • Bilateral upper extremity arteriovenous access
  • Average plasma sodium \>139

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

Related Publications (1)

  • de Paula FM, Peixoto AJ, Pinto LV, Dorigo D, Patricio PJ, Santos SF. Clinical consequences of an individualized dialysate sodium prescription in hemodialysis patients. Kidney Int. 2004 Sep;66(3):1232-8. doi: 10.1111/j.1523-1755.2004.00876.x.

    PMID: 15327422BACKGROUND

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Aldo J Peixoto, MD

    Yale University and VA Connecitcut Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2005

First Posted

October 12, 2005

Study Start

October 1, 2005

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

July 26, 2016

Record last verified: 2016-07

Locations

US(1)