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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02046785
Other study ID # Hemodinamica
Secondary ID
Status Recruiting
Phase N/A
First received July 11, 2013
Last updated January 24, 2014
Start date April 2013
Est. completion date May 2014

Study information

Verified date January 2014
Source Federal University of Uberlandia
Contact Rosangela O Felice, Expert
Phone +553432182258
Email rosangelafelice@gmail.com
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether hemodynamic measures vary in angles bedside before and after volume challenge.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date May 2014
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Other:
0.9% saline solution
comparing values obtained before and after administration of 500 ml of 0.9% salin

Locations

Country Name City State
Brazil Intensive Care Unit, Clinical Hospital, Federal University of Uberlandia Uberlandia Minas Gerais

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Uberlandia

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Different Backrest position's effect on CVP, CO and ?PP measures Data collection was performed at admission or within 10 days of hospitalization between September 2013 and February 2014. Yes
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