Relation Between Intrabdominal Pressure and Collapsibility Index of Inferior Vena Cava Before and After Fluid Therapy

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Keihan Golshani, Isfahan University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT01553422

First received: March 7, 2012

Last updated: December 3, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 7, 2012

Last Updated Date

December 3, 2012

Start Date ^ICMJE

March 2012

Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Emergency bedside Ultrasonography assessment of Inferior Vena cava collapsibility index before and after fluid therapy [ Time Frame: "up to 36 weeks" ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01553422 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Relation Between Intrabdominal Pressure and Collapsibility Index of Inferior Vena Cava Before and After Fluid Therapy

Official Title ^ICMJE

Assessment of Relation Between Intrabdominal Pressure and Collapsibility Index of Inferior Vena Cava by Emergency Ultrasonography Before and After Fluid Therapy

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Abdominal Compartment Syndrome

Intervention ^ICMJE

Other: Fluid therapy (Saline Normal)
Saline Normal 1 Lit. during 30 minutes
Other: Fluid therapy (Saline Normal)
saline Normal 1 lit during 30 minutes

Study Arm (s)

Active Comparator: before fluid Therapy
Intervention: Other: Fluid therapy (Saline Normal)
Active Comparator: after fluid Therapy
Intervention: Other: Fluid therapy (Saline Normal)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2012

Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Iran, Islamic Republic of

Administrative Information

NCT Number ^ICMJE

NCT01553422

Other Study ID Numbers ^ICMJE

390331

Has Data Monitoring Committee

Yes

Responsible Party

Keihan Golshani, Isfahan University of Medical Sciences

Study Sponsor ^ICMJE

Isfahan University of Medical Sciences

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

KEIHAN GOLSHANI, M.D.

Isfahan University of Medical Sciences

Information Provided By

Isfahan University of Medical Sciences

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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