NCT02046785

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

January 28, 2014

Status Verified

January 1, 2014

Enrollment Period

5 months

First QC Date

July 11, 2013

Last Update Submit

January 24, 2014

Conditions

Keywords

Fluid administrationCardiac outputRight atrial pressureResuscitation

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

0.9% saline solution

OTHER

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

Other: 0.9% saline solution

Interventions

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

Also known as: Solution of 0.9% NaCl in distilled water
0.9% saline solution

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Unit, Clinical Hospital, Federal University of Uberlandia

Uberlândia, Minas Gerais, 38405-382, Brazil

RECRUITING

MeSH Terms

Conditions

Shock

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Rosangela O Felice, expert

    Federal University of Uberlandia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosangela O Felice, Expert

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
nursing specialist

Study Record Dates

First Submitted

July 11, 2013

First Posted

January 28, 2014

Study Start

April 1, 2013

Primary Completion

September 1, 2013

Study Completion

May 1, 2014

Last Updated

January 28, 2014

Record last verified: 2014-01

Locations