Measurements of Colloid Osmotic Pressure in Interstitial... | NCT01044979

Studies
Measurements of Colloid Osmotic Pressure in Interstitial Fluid and Plasma

NCT01044979

Sponsor

Haukeland University Hospital

Status

Completed

Last Update Posted

Jul 4, 2014Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Colloid Osmotic Pressure

Interventions

Not provided

Countries

Norway

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

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Dec 17, 2009

First Submission Date that Met QC Criteria

Jan 7, 2010

First Posted Date

Jan 8, 2010Estimated

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

Jul 3, 2014

Last Update Posted Date

Jul 4, 2014Estimated

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

The purpose of this study is to evaluate a method of sampling interstitial fluid from subcutaneous sewn wicks.

Detailed Description

Fluid loss from circulating plasma volume is one of the contributors of oedema formation. Measurement of colloid osmotic pressure (COP) both in plasma and in interstitial fluid can be utilised in planing of fluid therapy in patients with oedema. Different methods of sampling interstitial fluid are well validated in animal models, but not in human. Sampling of interstitial fluid by subcutaneous sewn wicks is a well-known method and can be painful. Local anaesthetics can reduce pain. By comparing interstitial fluid taken from areas with or without application of local anaesthetics, a possible influence in COP values can be detected.

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

Retention

Enrollment

50Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Colloid osmotic pressure		60 and 90 minuttes after implanting wicks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults over 18 years

Exclusion Criteria:

Ongoing illness
Medication

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Healthy volunteers over 18 years.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hans Joergen T Guthe, MD	Haukeland University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Haukeland University Hospital		Bergen	Bergen	5021	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22348071	Derived	Guthe HJ, Nedrebo T, Tenstad O, Wiig H, Berg A. Effect of topical anaesthetics on interstitial colloid osmotic pressure in human subcutaneous tissue sampled by wick technique. PLoS One. 2012;7(2):e31332. doi: 10.1371/journal.pone.0031332. Epub 2012 Feb 14.