Colloid Osmotic PressureNCT01044979
Measurements of Colloid Osmotic Pressure in Interstitial Fluid and Plasma
An observational study of Colloid Osmotic Pressure, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to evaluate a method of sampling interstitial fluid from subcutaneous sewn wicks. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Colloid Osmotic Pressure
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2009to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy volunteers over 18 years.
Who may be able to join
- Adults over 18 years
Who cannot join
- Ongoing illness
- Medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measurements of Colloid Osmotic Pressure in Interstitial Fluid and Plasma, a Methodological Study
The purpose of this study is to evaluate a method of sampling interstitial fluid from subcutaneous sewn wicks.
Read the 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.
- Conditions
- Colloid Osmotic Pressure
- Keywords
- Colloid osmotic pressure in interstitial fluid, Colloid osmotic pressure in plasma, Protein fractions in interstitial fluid
What is being measured
The primary outcome is the main question the study is designed to answer.
Colloid osmotic pressure
Measured: 60 and 90 minuttes after implanting wicks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colloid Osmotic PressureStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans Joergen T Guthe, MD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044979
- Sponsor's protocol ID
- 071223
- Status last verified
- Jul 2014
- First submitted
- 17 Dec 2009
- Last updated
- 4 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22348071
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurements of Colloid Osmotic Pressure in Interstitial Fluid and Plasma, a Methodological Study
- ClinicalTrials.gov ID
- NCT01044979
- Acronym / sponsor ID
- 071223
- Conditions
- Colloid Osmotic Pressure
- Keywords
- Colloid osmotic pressure in interstitial fluid, Colloid osmotic pressure in plasma, Protein fractions in interstitial fluid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 8 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy volunteers over 18 years.
Key inclusion criteria (1 listed)
- Adults over 18 years
Key exclusion criteria (2 listed)
- Ongoing illness
- Medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Colloid osmotic pressure
Time frame: 60 and 90 minuttes after implanting wicks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2014.
- Derived from this study: PubMed 22348071Guthe 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Joergen T Guthe, MD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colloid Osmotic Pressure, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colloid osmotic pressure (time frame: 60 and 90 minuttes after implanting wicks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01044979, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2014.