NCT01553422

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 14, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

December 4, 2012

Status Verified

December 1, 2012

Enrollment Period

7 months

First QC Date

March 7, 2012

Last Update Submit

December 3, 2012

Conditions

Abdominal Compartment Syndrome

Keywords

Intrabdominal PressureEmergency Bedside UltrasonographyAbdominal Compartment Syndrome

Outcome Measures

Primary Outcomes (1)

  • Emergency bedside Ultrasonography assessment of Inferior Vena cava collapsibility index before and after fluid therapy

    "up to 36 weeks"

Study Arms (2)

before fluid Therapy

ACTIVE COMPARATOR
Other: Fluid therapy (Saline Normal)

after fluid Therapy

ACTIVE COMPARATOR
Other: Fluid therapy (Saline Normal)

Interventions

Fluid therapy (Saline Normal)OTHER

Saline Normal 1 Lit. during 30 minutes

before fluid Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body Mass index less than 30
  • Written agree of the patient to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency department, Alzahra General Hospital

Isfahan, Isfahan, Iran

Location

MeSH Terms

Conditions

Intra-Abdominal Hypertension

Interventions

Fluid TherapySodium Chloride

Condition Hierarchy (Ancestors)

Compartment SyndromesMuscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • KEIHAN GOLSHANI, M.D.

    Isfahan University of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Emergency Medicine, Director of Emergency Medicine Residency Program

Study Record Dates

First Submitted

March 7, 2012

First Posted

March 14, 2012

Study Start

March 1, 2012

Primary Completion

October 1, 2012

Study Completion

November 1, 2012

Last Updated

December 4, 2012

Record last verified: 2012-12

Locations

IR(1)