Presep and Vascath Interaction Study | NCT00739089

Studies
Presep and Vascath Interaction Study

NCT00739089

Sponsor

Wake Forest University Health Sciences

Status

Withdrawn

Last Update Posted

Nov 8, 2017Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Hemodynamics
Renal Dialysis
Sepsis
Shock

Interventions

Not provided

Countries

United States

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

Jan 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study stopped due to a lack of enrollment.

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Aug 20, 2008

First Submission Date that Met QC Criteria

Aug 20, 2008

First Posted Date

Aug 21, 2008Estimated

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

Nov 6, 2017

Last Update Posted Date

Nov 8, 2017Actual

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

This is a prospective, observational study to compare presep(tm) catheter central vein mixed venous oxygen saturation before and after dialysis is initiated via the vascath(tm) central venous dialysis catheter to evaluate device interaction.

Detailed Description

The central venous oxygen saturation catheter measurement may be influenced by close approximation to the tip of the central venous hemodialysis catheter when hemodialysis is ongoing.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in SvO2		before and afer initiation of dialysis via a vascath

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Admitted to the MICU
PreSep venous oxygen saturation central venous catheter already in place
VasCath central venous dialysis catheter already in place
Planned hemodialysis

Exclusion Criteria:

Patient unable to undergo hemodialysis
Contraindication for PreSep or VasCath catheters

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

medical intensive care unit (MICU) patients in an academic tertiary care referral medical center.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arjun B Chatterjee, MD, MS	Wake Forest University Health Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wake Forest University Health Sciences		Winston-Salem	North Carolina	27157	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
6496536	Background	Vaziri ND, Wilson A, Mukai D, Darwish R, Rutz A, Hyatt J, Moreno C. Dialysis hypoxemia. Role of dialyzer membrane and dialysate delivery system. Am J Med. 1984 Nov;77(5):828-33. doi: 10.1016/0002-9343(84)90519-9.
11445693	Background	Jakob SM, Ruokonen E, Vuolteenaho O, Lampainen E, Takala J. Splanchnic perfusion during hemodialysis: evidence for marginal tissue perfusion. Crit Care Med. 2001 Jul;29(7):1393-8. doi: 10.1097/00003246-200107000-00015.

ID	Term
D018805	Sepsis
D012769	Shock
D007022	Hypotension
D000140	Acidosis, Lactic

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes