NCT00119990

Brief Summary

During peritoneal dialysis, water is removed from the body. This sometimes occurs at rates of up to 500 ml/h. During shifts with dialysate with high glucose content, an increase in blood pressure has been described. The effect upon central hemodynamics is unknown. The researchers are investigating the effects of low and high glucose dialysate and icodextrin on cardiac output, stroke volume, pulse rate and blood pressure. The researchers have hypothesized that the effects seen are induced by vasopressin.

Trial Health

57
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Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

July 5, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 14, 2005

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

December 8, 2008

Status Verified

December 1, 2008

Enrollment Period

3 years

First QC Date

July 5, 2005

Last Update Submit

December 5, 2008

Conditions

Peritoneal Dialysis

Keywords

vasopressinicodextrincardiac output

Outcome Measures

Primary Outcomes (1)

  • Changes in cardiac hemodynamics. (Cardiac Output, stroke volume, pulse rate, blood pressure and total peripheral resistance)

    4 hours

Interventions

Icodextrin (dialysate)DRUG

2 liter of extraneal are given with one fill for 4 hours.

Physioneal (dialysate) 1.36% and 2.27%DRUG

2 liter of Physioneal of 1.36% or 3.86% are given with one fill for 4 hours one two different days.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Peritoneal dialysis patients

You may not qualify if:

  • Insulin dependent diabetes mellitus
  • AV-fistula, cardial arrhythmia persistence, or severe cardiac and lung disease
  • Recent infectious disease
  • Severe psychiatric disease
  • Hypersensitivity to icodextrin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deparment of Renal Medicine, Skejby Hospital

Aarhus, 8200, Denmark

Location

Related Publications (1)

  • Boon D, Bos WJ, van Montfrans GA, Krediet RT. Acute effects of peritoneal dialysis on hemodynamics. Perit Dial Int. 2001 Mar-Apr;21(2):166-71.

    PMID: 11330561BACKGROUND

MeSH Terms

Conditions

Diabetes Insipidus

Interventions

IcodextrinDialysis Solutions

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Per Ivarsen

    Department of Renal Medicine C, Skejby Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 5, 2005

First Posted

July 14, 2005

Study Start

January 1, 2006

Primary Completion

January 1, 2009

Study Completion

January 1, 2010

Last Updated

December 8, 2008

Record last verified: 2008-12

Locations

DK(1)