search
Back to results

Hemodynamic Measurements at Different Inclinations of the Head (HMDIH)

Primary Purpose

Hypovolemic Shock

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
0.9% saline solution
Sponsored by
Federal University of Uberlandia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypovolemic Shock focused on measuring Fluid administration, Cardiac output, Right atrial pressure, Resuscitation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Being in circulatory shock and have at least one of the following criteria to identify loss of tissue perfusion: systolic blood pressure <90 mmHg or need for vasoactive drugs, urine output below 0.5 ml / kg / h.
  • Being under sedation, assessed by the scale of Richmond agitation and sedation (RASS) -5, mechanically ventilated in volume control mode with tidal volume between 8 to 12 ml/kg, PEEP to 8 cm H2O.
  • Tue signing the informed consent by legal guardian.

Exclusion Criteria:

  • Presence cardiac arrhythmias.
  • Presence of abdominal or thoracic trauma.
  • Contraindication for passive elevation of the members.
  • Hypoxia significant PaO2/FiO2 < or equal 100.

Sites / Locations

  • Intensive Care Unit, Clinical Hospital, Federal University of UberlandiaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

0.9% saline solution

Arm Description

comparing values obtained before and after administration of 500 ml of 0.9% saline

Outcomes

Primary Outcome Measures

Different Backrest position's effect on CVP, CO and ∆PP measures

Secondary Outcome Measures

Full Information

First Posted
July 11, 2013
Last Updated
January 24, 2014
Sponsor
Federal University of Uberlandia
search

1. Study Identification

Unique Protocol Identification Number
NCT02046785
Brief Title
Hemodynamic Measurements at Different Inclinations of the Head
Acronym
HMDIH
Official Title
Comparison of CVP Values , ΔPP and Echocardiographic at Different Angles Headwaters Before and After Volume Challenge
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Uberlandia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether hemodynamic measures vary in angles bedside before and after volume challenge.
Detailed Description
Check if values of central venous pressure (CVP), pulse pressure variation (Δpp), heart rate (HR), mean arterial pressure ((PAM) vary in different angles headboards Compare values of CVP, Δpp, HR and MAP as predictors of blood volume after supply of 500 ml of 0.9% saline solution.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypovolemic Shock
Keywords
Fluid administration, Cardiac output, Right atrial pressure, Resuscitation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
0.9% saline solution
Arm Type
Other
Arm Description
comparing values obtained before and after administration of 500 ml of 0.9% saline
Intervention Type
Other
Intervention Name(s)
0.9% saline solution
Other Intervention Name(s)
Solution of 0.9% NaCl in distilled water
Intervention Description
comparing values obtained before and after administration of 500 ml of 0.9% salin
Primary Outcome Measure Information:
Title
Different Backrest position's effect on CVP, CO and ∆PP measures
Time Frame
Data collection was performed at admission or within 10 days of hospitalization between September 2013 and February 2014.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being in circulatory shock and have at least one of the following criteria to identify loss of tissue perfusion: systolic blood pressure <90 mmHg or need for vasoactive drugs, urine output below 0.5 ml / kg / h. Being under sedation, assessed by the scale of Richmond agitation and sedation (RASS) -5, mechanically ventilated in volume control mode with tidal volume between 8 to 12 ml/kg, PEEP to 8 cm H2O. Tue signing the informed consent by legal guardian. Exclusion Criteria: Presence cardiac arrhythmias. Presence of abdominal or thoracic trauma. Contraindication for passive elevation of the members. Hypoxia significant PaO2/FiO2 < or equal 100.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rosangela O Felice, Expert
Phone
+553432182258
Email
rosangelafelice@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosangela O Felice, expert
Organizational Affiliation
Federal University of Uberlandia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intensive Care Unit, Clinical Hospital, Federal University of Uberlandia
City
Uberlandia
State/Province
Minas Gerais
ZIP/Postal Code
38405-382
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosangela O Felice, Expert
Phone
+553432182258
Email
rosangelafelice@gmail.com
First Name & Middle Initial & Last Name & Degree
Rosangela O Felice, Expert
First Name & Middle Initial & Last Name & Degree
Elmiro S Resende, Doctor
First Name & Middle Initial & Last Name & Degree
Thulio M Cunha, Doctor

12. IPD Sharing Statement

Learn more about this trial

Hemodynamic Measurements at Different Inclinations of the Head

We'll reach out to this number within 24 hrs