IVC Collapsibility IndexNCT01741818
The Cutoff Point for Caval Index and Its Correlation With Central Venous Pressure and Plasma Lactate Level for Assessing Patients in Hypovolemic Hemorrhagic States
An observational study of IVC Collapsibility Index and Hemorrhagic Shock, run by Isfahan University of Medical Sciences at 2 sites in Iran.
Trial summary
The purpose of this study is to determine the cutoff point for IVC collapsibility index (by Bedside Ultrasonographic technique) for cases in hypovolemic hemorrhagic shock with CVP measures less than 8 cmH2o. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IVC Collapsibility Index, Hemorrhagic Shock
- What is being tested?
- Measuring IVC collapsibility index by bedside ultrasonography
- How many people
- 106 participants
- Where
- 2 sitesIran
- Study dates
- Apr 2011to Mar 2012
- 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: cases in hypovolemic hemorrhagic status (class II or more) that presented to our ED
Who may be able to join
- Hypovolemic hemorrhagic subjects (class II or more)if they were more than 18 years old and CVC insertion was indicated for them.
Who cannot join
- a history of Renal failure, Congestive Heart Failure, use of negative inotropic agents, presence of any contraindication for CVC insertion or failed ones and inability for measuring IVC by bUS were considered for exclusion.
Trial locations and contacts
2 sites in 1 country.
Iran2 sites
Emergency Department of alzahra General Hospital, Isfahan University of Medical Sciences
Isfahan, Isfahan
Kerman University of Medical Sciences
Kerman, Kerman
About this study
The purpose of this study is to determine the cutoff point for IVC collapsibility index (by Bedside Ultrasonographic technique) for cases in hypovolemic hemorrhagic shock with CVP measures less than 8 cmH2o.
- Conditions
- IVC Collapsibility Index, Hemorrhagic Shock
- Being tested
- Measuring IVC collapsibility index by bedside ultrasonography
- Keywords
- IVC, ultrasonography, IVC collapsibility index, IVC diameter
- Medical subject headings
- Shock, Hemorrhagic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measuring IVC collapsibility index by bedside ultrasonographyOther
| Study group | Role | What they receive |
|---|---|---|
| Group B | CVP less than 8cmH2o Receives: Other: Measuring IVC collapsibility index by bedside ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
IVC collapsibility index
Measured: within the first 5 minutes
Secondary outcomes (1)
Serum lactate level
Measured: within the first 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startApr 2011
- Primary completionJan 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVC Collapsibility IndexStudies 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keihan Golshani, Isfahan University of Medical Sciences
- Investigators
- Keihan Golshani, MD., Study chair, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741818
- Sponsor's protocol ID
- IUMS-14746
- Status last verified
- Dec 2012
- First submitted
- 3 Dec 2012
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cutoff Point for Caval Index and Its Correlation With Central Venous Pressure and Plasma Lactate Level for Assessing Patients in Hypovolemic Hemorrhagic States
- ClinicalTrials.gov ID
- NCT01741818
- Acronym / sponsor ID
- IUMS-14746
- Conditions
- IVC Collapsibility Index, Hemorrhagic Shock
- Keywords
- IVC, ultrasonography, IVC collapsibility index, IVC diameter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 5 Dec 2012 (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 determine the cutoff point for IVC collapsibility index (by Bedside Ultrasonographic technique) for cases in hypovolemic hemorrhagic shock with CVP measures less than 8 cmH2o.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group B | – | Other: Measuring IVC collapsibility index by bedside ultrasonographyCVP less than 8cmH2o |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cases in hypovolemic hemorrhagic status (class II or more) that presented to our ED
Key inclusion criteria (1 listed)
- Hypovolemic hemorrhagic subjects (class II or more)if they were more than 18 years old and CVC insertion was indicated for them.
Key exclusion criteria (1 listed)
- a history of Renal failure, Congestive Heart Failure, use of negative inotropic agents, presence of any contraindication for CVC insertion or failed ones and inability for measuring IVC by bUS were considered for exclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measuring IVC collapsibility index by bedside ultrasonography | Other | Group B |
Primary outcome
IVC collapsibility index
Time frame: within the first 5 minutes
1 secondary outcome
Serum lactate level
Time frame: within the first 5 minutes
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 5 Dec 2012.
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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.
Keihan Golshani, MD. study chair
Isfahan University of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IVC Collapsibility Index and Hemorrhagic Shock, run by Isfahan University of Medical Sciences at 2 sites in Iran.
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 1 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 5 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. 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?
IVC collapsibility index (time frame: within the first 5 minutes). 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 5 Dec 2012.