the Study Focuses on the Subgoup of Patients With Decreased Effective Blood Volume eg. Trauma Surgical and Non Surgical PatientsNCT02474056
The Impact of the Fluid Resuscitation on the Venous Volume and Flow Characteristics in Hypovolemic Shock
An observational study of the Study Focuses on the Subgoup of Patients With Decreased Effective Blood Volume eg. Trauma Surgical and Non Surgical Patients, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
We hypothesis that in various situation when the effective blood volume decreased the venous volume flow characteristics change according to the fluid resuscitation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- the Study Focuses on the Subgoup of Patients With Decreased Effective Blood Volume eg. Trauma Surgical and Non Surgical Patients
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2010to Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients admitted at haemek medical center
Who may be able to join
- age > 18 years old
- decreased effective blood volume
- Systolic blood pressure < 100
- Pulse rate > 110
Who cannot join
- age <18 years old
- pregnancy
- patient requires urgent surgical intervention
Trial locations and contacts
1 site in 1 country.
About this study
We hypothesis that in various situation when the effective blood volume decreased the venous volume flow characteristics change according to the fluid resuscitation
Read the detailed description
Patients with clinical signs of loss of the effective blood volume will undergo ultrasound examination of several major veins. The purpose of this examination is to determine vein volume(size) and flow. The ultrasound examination will be done before fluid resuscitation, after fluid administration,and three days after admission
- Keywords
- decreased blood volume vein volume flow ultrasound exam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| trauma patients | patients with decreased blood volume | |
| surgical patients | patients with decreased blood volume | |
| non surgical patients | patients with decreased blood voloume |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood volume
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study startJan 2010
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: The researcher couldnt handle it
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Study Focuses on the Subgoup of Patients With Decreased Effective Blood Volume eg. Trauma Surgical and Non Surgical PatientsStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kopelman doron, HaEmek Medical Center, Israel
- Investigators
- Doron Kopelman, Md, Principal investigator, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474056
- Sponsor's protocol ID
- 0018-09-EMC
- Other IDs
- 0018-09--EMC
- Status last verified
- Sep 2016
- First submitted
- 14 Jun 2015
- Last updated
- 29 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Fluid Resuscitation on the Venous Volume and Flow Characteristics in Hypovolemic Shock
- ClinicalTrials.gov ID
- NCT02474056
- Acronym / sponsor ID
- 0018-09-EMC
- Keywords
- decreased blood volume vein volume flow ultrasound exam
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The researcher couldnt handle it
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 17 Jun 2015 (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.
We hypothesis that in various situation when the effective blood volume decreased the venous volume flow characteristics change according to the fluid resuscitation
Detailed description
Patients with clinical signs of loss of the effective blood volume will undergo ultrasound examination of several major veins. The purpose of this examination is to determine vein volume(size) and flow. The ultrasound examination will be done before fluid resuscitation, after fluid administration,and three days after admission
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| trauma patients | – | –patients with decreased blood volume |
| surgical patients | – | –patients with decreased blood volume |
| non surgical patients | – | –patients with decreased blood voloume |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted at haemek medical center
Key inclusion criteria (4 listed)
- age > 18 years old
- decreased effective blood volume
- Systolic blood pressure < 100
- Pulse rate > 110
Key exclusion criteria (3 listed)
- age <18 years old
- pregnancy
- patient requires urgent surgical intervention
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
blood volume
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
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.
Doron Kopelman, Md principal investigator
haemek medical center
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 the Study Focuses on the Subgoup of Patients With Decreased Effective Blood Volume eg. Trauma Surgical and Non Surgical Patients, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 4 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: withdrawn, as of the sponsor's last update on 29 Sep 2016. 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 Israel. 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 was withdrawn before enrolling participants, so there are no results.
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?
blood volume (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2016.