Hypovolemic ShockHMDIHNCT02046785
Hemodynamic Measurements at Different Inclinations of the Head
A study testing 0.9% saline solution in people with Hypovolemic Shock, run by Federal University of Uberlandia at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether hemodynamic measures vary in angles bedside before and after volume challenge. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hypovolemic Shock
- What is being tested?
- 0.9% saline solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2013to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Presence cardiac arrhythmias.
- Presence of abdominal or thoracic trauma.
- Contraindication for passive elevation of the members.
- Hypoxia significant PaO2/FiO2 < or equal 100.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Intensive Care Unit, Clinical Hospital, Federal University of Uberlandia
Uberlândia, Minas Gerais, 38405-382
Rosangela O Felice, Expert, +553432182258, rosangelafelice@gmail.com
Rosangela O Felice, Expert
About this study
Official title: Comparison of CVP Values , ΔPP and Echocardiographic at Different Angles Headwaters Before and After Volume Challenge
The purpose of this study is to determine whether hemodynamic measures vary in angles bedside before and after volume challenge.
Read the 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.
- Conditions
- Hypovolemic Shock
- Being tested
- 0.9% saline solution
- Keywords
- Fluid administration, Cardiac output, Right atrial pressure, Resuscitation
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% saline solutionOther
Also called Solution of 0.9% NaCl in distilled water
comparing values obtained before and after administration of 500 ml of 0.9% salin
| Study group | Role | What they receive |
|---|---|---|
| 0.9% saline solution | Other | comparing values obtained before and after administration of 500 ml of 0.9% saline Receives: Other: 0.9% saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Different Backrest position's effect on CVP, CO and ∆PP measures
Measured: Data collection was performed at admission or within 10 days of hospitalization between September 2013 and February 2014.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startApr 2013
- Primary completionSep 2013
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypovolemic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosangela de Oliveira Felice, Federal University of Uberlandia
- Investigators
- Rosangela O Felice, expert, Principal investigator, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046785
- Sponsor's protocol ID
- Hemodinamica
- Acronym
- HMDIH
- Status last verified
- Jan 2014
- First submitted
- 11 Jul 2013
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of CVP Values , ΔPP and Echocardiographic at Different Angles Headwaters Before and After Volume Challenge
- ClinicalTrials.gov ID
- NCT02046785
- Acronym / sponsor ID
- HMDIH / Hemodinamica
- Conditions
- Hypovolemic Shock
- Keywords
- Fluid administration, Cardiac output, Right atrial pressure, Resuscitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- May 2014 (estimated)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 0.9% saline solution | Other | Other: 0.9% saline solutioncomparing values obtained before and after administration of 500 ml of 0.9% saline |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Presence cardiac arrhythmias.
- Presence of abdominal or thoracic trauma.
- Contraindication for passive elevation of the members.
- Hypoxia significant PaO2/FiO2 < or equal 100.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.9% saline solutionAlso: Solution of 0.9% NaCl in distilled watercomparing values obtained before and after administration of 500 ml of 0.9% salin | Other | 0.9% saline solution |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosangela O Felice, expert principal investigator
Federal University of Uberlandia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.9% saline solution in people with Hypovolemic Shock, run by Federal University of Uberlandia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rosangela O Felice, Expert (+553432182258, rosangelafelice@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2014.