Changes in Cardiovascular Hemodynamics During Peritoneal... | NCT00119990

Studies
Changes in Cardiovascular Hemodynamics During Peritoneal Dialysis

NCT00119990

Sponsor

University of Aarhus

Status

Terminated

Last Update Posted

Dec 8, 2008Estimated

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Peritoneal Dialysis

Interventions

Icodextrin (dialysate)
Physioneal (dialysate) 1.36% and 2.27%

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Jan 2009Estimated

Completion Date

Jan 2010Estimated

First Submitted Date

Jul 5, 2005

First Submission Date that Met QC Criteria

Jul 5, 2005

First Posted Date

Jul 14, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2008

Last Update Posted Date

Dec 8, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in cardiac hemodynamics. (Cardiac Output, stroke volume, pulse rate, blood pressure and total peripheral resistance)		4 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Per Ivarsen	Department of Renal Medicine C, Skejby Hospital, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Deparment of Renal Medicine, Skejby Hospital		Aarhus		8200	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11330561	Background	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.

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

ID	Term
D005936	Glucans
D001704	Biopolymers
D011108	Polymers
D046911	Macromolecular Substances

ID	Term
D000077607	Icodextrin
D015314	Dialysis Solutions