Back to resultsRelation Between Intrabdominal Pressure and Collapsibility Index of Inferior Vena Cava Before and After Fluid Therapy
Primary Purpose
Abdominal Compartment Syndrome
Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Fluid therapy (Saline Normal)
Fluid therapy (Saline Normal)
Sponsored by
About this trial
This is an interventional diagnostic trial for Abdominal Compartment Syndrome focused on measuring Intrabdominal Pressure, Emergency Bedside Ultrasonography, Abdominal Compartment Syndrome
Eligibility Criteria
Inclusion Criteria:
- Body Mass index less than 30
- Written agree of the patient to participate in the study
Exclusion Criteria:
- 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
Sites / Locations
- Emergency department, Alzahra General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
before fluid Therapy
after fluid Therapy
Arm Description
Outcomes
Primary Outcome Measures
Emergency bedside Ultrasonography assessment of Inferior Vena cava collapsibility index before and after fluid therapy
Secondary Outcome Measures
Full Information
NCT ID
NCT01553422
First Posted
March 7, 2012
Last Updated
December 3, 2012
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01553422
Brief Title
Relation Between Intrabdominal Pressure and Collapsibility Index of Inferior Vena Cava Before and After Fluid Therapy
Official Title
Assessment of Relation Between Intrabdominal Pressure and Collapsibility Index of Inferior Vena Cava by Emergency Ultrasonography Before and After Fluid Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Compartment Syndrome
Keywords
Intrabdominal Pressure, Emergency Bedside Ultrasonography, Abdominal Compartment Syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
before fluid Therapy
Arm Type
Active Comparator
Arm Title
after fluid Therapy
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Fluid therapy (Saline Normal)
Intervention Description
Saline Normal 1 Lit. during 30 minutes
Intervention Type
Other
Intervention Name(s)
Fluid therapy (Saline Normal)
Intervention Description
saline Normal 1 lit during 30 minutes
Primary Outcome Measure Information:
Title
Emergency bedside Ultrasonography assessment of Inferior Vena cava collapsibility index before and after fluid therapy
Time Frame
"up to 36 weeks"
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Body Mass index less than 30
Written agree of the patient to participate in the study
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KEIHAN GOLSHANI, M.D.
Organizational Affiliation
Isfahan University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Emergency department, Alzahra General Hospital
City
Isfahan
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Relation Between Intrabdominal Pressure and Collapsibility Index of Inferior Vena Cava Before and After Fluid Therapy
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