Abdominal Compartment SyndromePhase 4NCT01553422
Relation Between Intrabdominal Pressure and Collapsibility Index of Inferior Vena Cava Before and After Fluid Therapy
A Phase 4 study testing Fluid therapy (Saline Normal) in people with Abdominal Compartment Syndrome, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
This study assess the relation between intra abdominal pressure and collapsibility index of inferior vena cava in emergency bedside ultrasonography before and after fluid therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Compartment Syndrome
- What is being tested?
- Fluid therapy (Saline Normal)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteIran
- Study dates
- Mar 2012to Nov 2012
- Phase
- Phase 4
- 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
Who may be able to join
- Body Mass index less than 30
- Written agree of the patient to participate in the study
Who cannot join
- neurogenic bladder or any documented previous surgery on bladder, spastic or contractile bladder
- large abdominal hernia
- patients who received neuromuscular blocking agents
- Patients with abdominal respiration due to chest pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Relation Between Intrabdominal Pressure and Collapsibility Index of Inferior Vena Cava by Emergency Ultrasonography Before and After Fluid Therapy
This study assess the relation between intra abdominal pressure and collapsibility index of inferior vena cava in emergency bedside ultrasonography before and after fluid therapy.
- Conditions
- Abdominal Compartment Syndrome
- Being tested
- Fluid therapy (Saline Normal)
- Keywords
- Intrabdominal Pressure, Emergency Bedside Ultrasonography, Abdominal Compartment Syndrome
- Medical subject headings
- Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid therapy (Saline Normal)Other
Saline Normal 1 Lit. during 30 minutes
Fluid therapy (Saline Normal)Other
saline Normal 1 lit during 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| before fluid Therapy | Active comparator | Not described Receives: Other: Fluid therapy (Saline Normal) |
| after fluid Therapy | Active comparator | Not described Receives: Other: Fluid therapy (Saline Normal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency bedside Ultrasonography assessment of Inferior Vena cava collapsibility index before and after fluid therapy
Measured: "up to 36 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Compartment SyndromeStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 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, M.D., Study chair, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553422
- Sponsor's protocol ID
- 390331
- Status last verified
- Dec 2012
- First submitted
- 7 Mar 2012
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Relation Between Intrabdominal Pressure and Collapsibility Index of Inferior Vena Cava by Emergency Ultrasonography Before and After Fluid Therapy
- ClinicalTrials.gov ID
- NCT01553422
- Acronym / sponsor ID
- 390331
- Conditions
- Abdominal Compartment Syndrome
- Keywords
- Intrabdominal Pressure, Emergency Bedside Ultrasonography, Abdominal Compartment Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 14 Mar 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.
This study assess the relation between intra abdominal pressure and collapsibility index of inferior vena cava in emergency bedside ultrasonography before and after fluid therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| before fluid Therapy | Active comparator | Other: Fluid therapy (Saline Normal) |
| after fluid Therapy | Active comparator | Other: Fluid therapy (Saline Normal) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body Mass index less than 30
- Written agree of the patient to participate in the study
Key exclusion criteria (4 listed)
- neurogenic bladder or any documented previous surgery on bladder, spastic or contractile bladder
- large abdominal hernia
- patients who received neuromuscular blocking agents
- Patients with abdominal respiration due to chest pain
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 |
|---|---|---|
| Fluid therapy (Saline Normal)Saline Normal 1 Lit. during 30 minutes | Other | before fluid Therapy |
| Fluid therapy (Saline Normal)saline Normal 1 lit during 30 minutes | Other | after fluid Therapy |
Primary outcome
Emergency bedside Ultrasonography assessment of Inferior Vena cava collapsibility index before and after fluid therapy
Time frame: "up to 36 weeks"
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 Dec 2012.
Related trials for Abdominal Compartment Syndrome
Enrolling by invitationObservational study
WSACS 2026 Delphi Consensus on the Practical Management of Intra-abdominal Hypertension and Abdominal Compartment Syndrome
Intra-Abdominal Hypertension, Abdominal Compartment Syndrome
Not yet recruitingObservational study
From Blast Injury to Multicompartment Dysfunction:
Compartment Syndrome, Compartment Syndrome Nontraumatic Lower Extremity
Not yet recruitingObservational study
Intra-Abdominal Pressure, Respiratory Mechanics, and Ventilator Liberation After Emergency Major Laparotomy
Intra-Abdominal Hypertension, Respiratory Mechanics
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
Not yet recruitingObservational study
Cumulative Intra-Abdominal Pressure Burden and Acute Kidney Injury After Emergency Abdominal Surgery
Acute Kidney Injury, Intra-Abdominal Hypertension
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, M.D. study chair
Isfahan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluid therapy (Saline Normal) in people with Abdominal Compartment Syndrome, run by Isfahan University of Medical Sciences at 1 site 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 2 inclusion and 4 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 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 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Emergency bedside Ultrasonography assessment of Inferior Vena cava collapsibility index before and after fluid therapy (time frame: "up to 36 weeks"). 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 4 Dec 2012.