Colloid Osmotic PressureNCT01044641
Measurement of Colloid Osmotic Pressure in Plasma and Interstitial Fluid in Children
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 identify normal values of colloid osmotic pressure in interstitial fluid and plasma in healthy children between 2 and 10 years. Read more about this study
- Who is it for?
- Ages 2 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Colloid Osmotic Pressure
- How many people
- 99 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2009to May 2013
- 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 2 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Secondary care clinic (ENT)
Who may be able to join
- Children from 2 to 10 years
Who cannot join
- Medication
- Ongoing illness
- Syndromes
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to identify normal values of colloid osmotic pressure in interstitial fluid and plasma in healthy children between 2 and 10 years.
Read the detailed description
Measurements of colloid osmotic pressure (COP) by sampling of interstitial fluid from subcutaneous tissue and plasma are well documented in animal models and human adult studies. COP plays a major role in transcapillary fluid balance and is valuable in fluid therapy planning in critically ill patients. There are no data regarding interstitial fluid COP values in neither sick nor healthy children. Sampling of interstitial fluid by the wick method in children who is under general anaesthesia (ear-nose-throat operations) gives the opportunity to identify normal COP values in this age group.
- 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 minuttes after wick insertion
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 completionMay 2013
- Study completionMay 2013
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
- 99 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, Hanukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044641
- Sponsor's protocol ID
- 065816
- Status last verified
- Jul 2014
- First submitted
- 6 Jan 2010
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Guthe HJ, Indrebo M, Nedrebo T, Norgard G, Wiig H, Berg A. Interstitial fluid colloid osmotic pressure in healthy children. PLoS One. 2015 Apr 8;10(4):e0122779. doi: 10.1371/journal.pone.0122779. eCollection 2015.
PubMed 25853713
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Colloid Osmotic Pressure in Plasma and Interstitial Fluid in Children
- ClinicalTrials.gov ID
- NCT01044641
- Acronym / sponsor ID
- 065816
- 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
- 99 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (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 identify normal values of colloid osmotic pressure in interstitial fluid and plasma in healthy children between 2 and 10 years.
Detailed description
Measurements of colloid osmotic pressure (COP) by sampling of interstitial fluid from subcutaneous tissue and plasma are well documented in animal models and human adult studies. COP plays a major role in transcapillary fluid balance and is valuable in fluid therapy planning in critically ill patients. There are no data regarding interstitial fluid COP values in neither sick nor healthy children. Sampling of interstitial fluid by the wick method in children who is under general anaesthesia (ear-nose-throat operations) gives the opportunity to identify normal COP values in this age group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Secondary care clinic (ENT)
Key inclusion criteria (1 listed)
- Children from 2 to 10 years
Key exclusion criteria (3 listed)
- Medication
- Ongoing illness
- Syndromes
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 minuttes after wick insertion
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 8 Jul 2014.
- Derived from this study: PubMed 25853713Guthe HJ, Indrebo M, Nedrebo T, Norgard G, Wiig H, Berg A. Interstitial fluid colloid osmotic pressure in healthy children. PLoS One. 2015 Apr 8;10(4):e0122779. doi: 10.1371/journal.pone.0122779. eCollection 2015.
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
Hanukeland 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 3 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 8 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 minuttes after wick insertion). 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 NCT01044641, 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 8 Jul 2014.