Changes in Cardiovascular Hemodynamics During Peritoneal Dialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Peritoneal Dialysis

Keywords

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vasopressin icodextrin cardiac output

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Icodextrin (dialysate)

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

Intervention Type DRUG

Physioneal (dialysate) 1.36% and 2.27%

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Peritoneal dialysis patients

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Departement of Renal Medicine, Aarhus Universityhospital, Skejb

Principal Investigators

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Per Ivarsen

Role: PRINCIPAL_INVESTIGATOR

Department of Renal Medicine C, Skejby Hospital, Denmark

Locations

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Deparment of Renal Medicine, Skejby Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND

PMID: 11330561 (View on PubMed)

Other Identifiers

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AA20050009

Identifier Type: -

Identifier Source: org_study_id