Body Fluid RetentionNCT02702544
Effect of Passive Leg Raising for Fluid Responsiveness
A study testing CardioScreen 1000 - Haemodynamic Measurement System, Medis and SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System in people with Body Fluid Retention and Impedance, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Changes in volumetric hemodynamic parameters and fluid overload (Cardiac Index,Stroke Volume, Thoracic Fluid Content, Systemic Vascular Resistance) were measured using a impedance cardiography (ICG) (CardioScreen 1000 - Haemodynamic Measurement System, Medis. GmbH Ilmenau) while lifting the leg at different angles. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Body Fluid Retention, Impedance, Cardiac Output, Low
- What is being tested?
- CardioScreen 1000 - Haemodynamic Measurement System, Medis and SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- Mar 2016to Mar 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- give voluntary consent to participate in the study
- no clinical cardiovascular disease during the 6 months proceeding entry
Who cannot join
- not meet above criteria
- episode of illness (for example: infection)
- pregnancy
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical University of Warsaw, Department of Emergency Medicine
Warsaw, Masovia, 02-005
About this study
Official title: Effect of Passive Leg Rasing on Changes in Volumetric Hemodynamic Parameters Induced by Fluid Removal
Changes in volumetric hemodynamic parameters and fluid overload (Cardiac Index,Stroke Volume, Thoracic Fluid Content, Systemic Vascular Resistance) were measured using a impedance cardiography (ICG) (CardioScreen 1000 - Haemodynamic Measurement System, Medis. GmbH Ilmenau) while lifting the leg at different angles. The measurement lasted 12 minutes.
- Conditions
- Body Fluid Retention, Impedance, Cardiac Output, Low
- Being tested
- CardioScreen 1000 - Haemodynamic Measurement System, Medis, SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System
- Medical subject headings
- Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioScreen 1000 - Haemodynamic Measurement System, MedisDevice
Impedance cardiography (ICG)
SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring SystemDevice
Blood pressure monitoring every 1 min during leg elevation
| Study group | Role | What they receive |
|---|---|---|
| neutral position | Experimental | the patient is in the neutral position, located on his back on a flat surface Receives: Device: CardioScreen 1000 - Haemodynamic Measurement System, Medis; Device: SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System |
| legs raised for 20 degrees | Experimental | patient is placed on a flat surface, legs raised for 20 degrees, supported around ankles Receives: Device: CardioScreen 1000 - Haemodynamic Measurement System, Medis; Device: SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System |
| legs raised for 30 degrees | Experimental | patient is placed on a flat surface, legs raised for 30 degrees, supported around ankles Receives: Device: CardioScreen 1000 - Haemodynamic Measurement System, Medis; Device: SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System |
| legs raised for 45 degrees | Experimental | patient is placed on a flat surface, legs raised for 45 degrees, supported around ankles Receives: Device: CardioScreen 1000 - Haemodynamic Measurement System, Medis; Device: SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System |
| legs raised for 60 degrees | Experimental | patient is placed on a flat surface, legs raised for 60 degrees, supported around ankles Receives: Device: CardioScreen 1000 - Haemodynamic Measurement System, Medis; Device: SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in volumetric hemodynamic parameter- cardiac index [l/min/m2]) induced by fluid removal on leg elevation
Measured: 1 day
Secondary outcomes (6)
Changes in volumetric hemodynamic parameter- stroke volume [ml] induced by fluid removal on leg elevation
Measured: 1 day
Changes in volumetric hemodynamic parameter- systemic vascular resistance index [dyn·s·cm-5·m-2] induced by fluid removal on leg elevation
Measured: 1 day
Changes in fluid removal parameter- thoracic fluid content [1/kOhm] during leg elevation
Measured: 1 day
Changes in blood pressure values [mmHg] induced by fluid removal on leg elevation
Measured: 1 day
Changes in vascular parameter- thoracic arterial complicance [ml/mmHg/m-2] during leg elevation
Measured: 1 day
Changes in contractility parameter- acceleration index [1/100/s-2] during leg elevation
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Fluid RetentionStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Łukasz Szarpak, Medical University of Warsaw
- Investigators
- Lukasz Szarpak, PhD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702544
- Sponsor's protocol ID
- 02.014.1MR
- Status last verified
- Mar 2016
- First submitted
- 3 Mar 2016
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Passive Leg Rasing on Changes in Volumetric Hemodynamic Parameters Induced by Fluid Removal
- ClinicalTrials.gov ID
- NCT02702544
- Acronym / sponsor ID
- 02.014.1MR
- Conditions
- Body Fluid Retention, Impedance, Cardiac Output, Low
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 8 Mar 2016 (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.
Changes in volumetric hemodynamic parameters and fluid overload (Cardiac Index,Stroke Volume, Thoracic Fluid Content, Systemic Vascular Resistance) were measured using a impedance cardiography (ICG) (CardioScreen 1000 - Haemodynamic Measurement System, Medis. GmbH Ilmenau) while lifting the leg at different angles. The measurement lasted 12 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| neutral position | Experimental | Device: CardioScreen 1000 - Haemodynamic Measurement System, Medis, Device: SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring Systemthe patient is in the neutral position, located on his back on a flat surface |
| legs raised for 20 degrees | Experimental | Device: CardioScreen 1000 - Haemodynamic Measurement System, Medis, Device: SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring Systempatient is placed on a flat surface, legs raised for 20 degrees, supported around ankles |
| legs raised for 30 degrees | Experimental | Device: CardioScreen 1000 - Haemodynamic Measurement System, Medis, Device: SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring Systempatient is placed on a flat surface, legs raised for 30 degrees, supported around ankles |
| legs raised for 45 degrees | Experimental | Device: CardioScreen 1000 - Haemodynamic Measurement System, Medis, Device: SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring Systempatient is placed on a flat surface, legs raised for 45 degrees, supported around ankles |
| legs raised for 60 degrees | Experimental | Device: CardioScreen 1000 - Haemodynamic Measurement System, Medis, Device: SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring Systempatient is placed on a flat surface, legs raised for 60 degrees, supported around ankles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- give voluntary consent to participate in the study
- no clinical cardiovascular disease during the 6 months proceeding entry
Key exclusion criteria (3 listed)
- not meet above criteria
- episode of illness (for example: infection)
- pregnancy
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 |
|---|---|---|
| CardioScreen 1000 - Haemodynamic Measurement System, MedisImpedance cardiography (ICG) | Device | legs raised for 20 degrees, legs raised for 30 degrees, legs raised for 45 degrees, legs raised for 60 degrees, neutral position |
| SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring SystemBlood pressure monitoring every 1 min during leg elevation | Device | legs raised for 20 degrees, legs raised for 30 degrees, legs raised for 45 degrees, legs raised for 60 degrees, neutral position |
Primary outcome
Changes in volumetric hemodynamic parameter- cardiac index [l/min/m2]) induced by fluid removal on leg elevation
Time frame: 1 day
6 secondary outcomes
Changes in volumetric hemodynamic parameter- stroke volume [ml] induced by fluid removal on leg elevation
Time frame: 1 day
Changes in volumetric hemodynamic parameter- systemic vascular resistance index [dyn·s·cm-5·m-2] induced by fluid removal on leg elevation
Time frame: 1 day
Changes in fluid removal parameter- thoracic fluid content [1/kOhm] during leg elevation
Time frame: 1 day
Changes in blood pressure values [mmHg] induced by fluid removal on leg elevation
Time frame: 1 day
Changes in vascular parameter- thoracic arterial complicance [ml/mmHg/m-2] during leg elevation
Time frame: 1 day
Changes in contractility parameter- acceleration index [1/100/s-2] during leg elevation
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
Related trials for Body Fluid Retention
RecruitingPhase 2
Phase II Clinical Study of HRS-9057 Injection in Patients With Heart Failure-induced Fluid Retention
Fluid Retention Caused by Heart Failure
Active, not recruitingPhase 1
A Mass Balance Study of [14C]HRS-9057 for Injection in Healthy Participants
Fluid Retention Due to Heart Failure
Active, not recruiting
The Effect of Hydration Status on Substrate Oxidation at Rest and During Light and Moderate Exercise
Hydration Status, Substrate Metabolism During Exercise
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.
Lukasz Szarpak, PhD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CardioScreen 1000 - Haemodynamic Measurement System, Medis and SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System in people with Body Fluid Retention and Impedance, run by Medical University of Warsaw at 1 site in Poland.
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 2 inclusion and 3 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 9 Mar 2016. 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 Poland. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in volumetric hemodynamic parameter- cardiac index [l/min/m2]) induced by fluid removal on leg elevation (time frame: 1 day). 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 9 Mar 2016.