The Cutoff Point for Caval Index and Its Correlation With Central Venous Pressure and Plasma Lactate Level for Assessing Patients in Hypovolemic Hemorrhagic States

• Sponsor: Isfahan University of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT01741818
• Collaborator: (none)
• Enrollment: 106
• Locations: 2
• Duration (Months): 11
• Patients Per Site: 53
• Patients Per Site Per Month: 4.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
IVC Collapsibility Index; Hemorrhagic Shock	Other: Measuring IVC collapsibility index by bedside ultrasonography

Study Design

• Study Type: Observational
• Actual Enrollment: 106 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Group B CVP less than 8cmH2o	Other: Measuring IVC collapsibility index by bedside ultrasonography

Outcome Measures

Primary Outcome Measures

1. IVC collapsibility index [within the first 5 minutes]

Secondary Outcome Measures

1. Serum lactate level [within the first 5 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Hypovolemic hemorrhagic subjects (class II or more)if they were more than 18 years old and CVC insertion was indicated for them.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emergency Department of alzahra General Hospital, Isfahan University of Medical Sciences	Isfahan		Iran, Islamic Republic of
2	Kerman University of Medical Sciences	Kerman		Iran, Islamic Republic of

Sponsors and Collaborators

• Isfahan University of Medical Sciences

Investigators

• Study Chair: Keihan Golshani, MD., Isfahan University of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Keihan Golshani, Assistant Professor of Emergency Medicine, Isfahan University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT01741818
• Other Study ID Numbers: IUMS-14746
• First Posted: Dec 5, 2012
• Last Update Posted: Dec 5, 2012
• Last Verified: Dec 1, 2012

• Keywords provided by Keihan Golshani, Assistant Professor of Emergency Medicine, Isfahan University of Medical Sciences: IVC; ultrasonography; IVC collapsibility index; IVC diameter
• Additional relevant MeSH terms: Shock, Hemorrhagic

Study Results

No Results Posted as of Dec 5, 2012