Fluid ResponsivenessNCT01113073
The Distribution of Pressure in the Thorax During Mechanical Ventilation and Its Effects on the Circulation
A study testing ventilatory protocol, Elastic band and passive leg raising test in people with Fluid Responsiveness, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Fluid administration is a daily intervention on the intensive care unit to improve cardiac output (CO) and stabilize circulation in critically ill patients. Simultaneously, the volume status of the patient is very difficult to assess. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fluid Responsiveness
- What is being tested?
- ventilatory protocol, Elastic band and passive leg raising test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2010to Sep 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Elective open heart surgery.
Who cannot join
- Significant cardiac arrhythmias, including atrial fibrillation.
- Hemodynamical instability, as defined by a variation in heart rate, blood pressure and cardiac output of more than 10% during the 15-min period before starting the protocol.
- Recent myocardial infarction (< 3 mnd, troponine > 50 ug/l).
Trial locations and contacts
1 site in 1 country.
Peter Pickkers, MD, PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Nijmegen Medical Centre
Nijmegen
Peter Pickkers, MD, PhD, p.pickkers@ic.umcn.nl
Peter Pickker, MD, PhD
About this study
Fluid administration is a daily intervention on the intensive care unit to improve cardiac output (CO) and stabilize circulation in critically ill patients. Simultaneously, the volume status of the patient is very difficult to assess. Too little volume leads to inadequate organ perfusion followed by ischemia and organ failure. Too much volume may worsen heart failure and cause pulmonary and peripheral edema and contribute to further tissue injury and organ dysfunction. Although dynamic indices have been shown to be more accurate predictors of fluid responsiveness, this relevant and complex task is usually guided by static clinical variables and the specialist's interpretation due to the fact that the interpretation of dynamic parameters is not fully developed and that they are not universally available. This lack of understanding is partially because of the complex interaction with mechanical ventilation. The investigators hypothesize that knowing the distribution of ventilatory pressures will make it possible to index dynamic parameters to tidal volume and improve their predictive value concerning the volume status of the patient. In addition, it would be of interest to be able to predict fluid responsiveness in a non-invasive way, especially in critically ill patients. Up to now, continuous non-invasive cardiac output monitoring using Nexfin in critically ill patients has not been validated and also not tested for its ability to predict fluid responsiveness. The present research proposal evaluates the possibility and accuracy of the model flow analysis obtained by non-invasive finger arterial pressure measurements to determine fluid responsiveness using passive leg raising. It will also be compared to a more invasive method (that is currently used in the clinic) to assess its ability to measure absolute CO levels accurately. It may make it possible to assess fluid responsiveness in a non-invasive and patient friendly way.
- Conditions
- Fluid Responsiveness
- Being tested
- ventilatory protocol, Elastic band, passive leg raising test
- Keywords
- pulse pressure variation, hemodynamic monitoring, fluid responsiveness, mechanical ventilation, fluid therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ventilatory protocolOther
Ventilatory protocol for short period with four different tidal volumes (12 min)
Elastic bandOther
Placement of an elastic band around thorax to reduce thorax compliance
passive leg raising testOther
performing the passive leg raising test
| Study group | Role | What they receive |
|---|---|---|
| Elective open heart surgery | Experimental | Patients who had undergone elective open heart surgery Receives: Other: ventilatory protocol; Other: Elastic band; Other: passive leg raising test |
What is being measured
The primary outcome is the main question the study is designed to answer.
fluid responsiveness
pulse pressure variation (PPV), systolic pressure variation (SPV), stroke volume variation (SVV), pre-ejection period variation (dPEP)
Measured: 30 minutes around fluid challenge
Secondary outcomes (4)
Pressure distribution in thorax due to mechanical ventilation
mechanical ventilation with 4 different tidal volumes and decreased chest compliance
Measured: 30 minutes of varying tidal volumes
Dynamic indices in pressure support ventilation
Measured: 30 minutes of pressure support
non invasive prediction of fluid responsiveness
pulse contour analysis of cardiac output with finger cuff combined with passive leg raising test
Measured: 30 minutes around fluid challenge
pressure distribution and dynamic indices during spontaneous breathing
Measured: 5 minutes of spontaneous breathing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid ResponsivenessStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Benno Lansdorp, MSc., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113073
- Sponsor's protocol ID
- UMCN_IC_BL_01/2010
- Status last verified
- Jan 2010
- First submitted
- 22 Apr 2010
- Last updated
- 31 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Distribution of Pressure in the Thorax During Mechanical Ventilation and Its Effects on the Circulation
- ClinicalTrials.gov ID
- NCT01113073
- Acronym / sponsor ID
- UMCN_IC_BL_01/2010
- Conditions
- Fluid Responsiveness
- Keywords
- pulse pressure variation, hemodynamic monitoring, fluid responsiveness, mechanical ventilation, fluid therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 29 Apr 2010 (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.
Fluid administration is a daily intervention on the intensive care unit to improve cardiac output (CO) and stabilize circulation in critically ill patients. Simultaneously, the volume status of the patient is very difficult to assess. Too little volume leads to inadequate organ perfusion followed by ischemia and organ failure. Too much volume may worsen heart failure and cause pulmonary and peripheral edema and contribute to further tissue injury and organ dysfunction. Although dynamic indices have been shown to be more accurate predictors of fluid responsiveness, this relevant and complex task is usually guided by static clinical variables and the specialist's interpretation due to the fact that the interpretation of dynamic parameters is not fully developed and that they are not universally available. This lack of understanding is partially because of the complex interaction with mechanical ventilation. The investigators hypothesize that knowing the distribution of ventilatory pressures will make it possible to index dynamic parameters to tidal volume and improve their predictive value concerning the volume status of the patient. In addition, it would be of interest to be able to predict fluid responsiveness in a non-invasive way, especially in critically ill patients. Up to now, continuous non-invasive cardiac output monitoring using Nexfin in critically ill patients has not been validated and also not tested for its ability to predict fluid responsiveness. The present research proposal evaluates the possibility and accuracy of the model flow analysis obtained by non-invasive finger arterial pressure measurements to determine fluid responsiveness using passive leg raising. It will also be compared to a more invasive method (that is currently used in the clinic) to assess its ability to measure absolute CO levels accurately. It may make it possible to assess fluid responsiveness in a non-invasive and patient friendly way.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective open heart surgery | Experimental | Other: ventilatory protocol, Other: Elastic band, Other: passive leg raising testPatients who had undergone elective open heart surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Elective open heart surgery.
Key exclusion criteria (3 listed)
- Significant cardiac arrhythmias, including atrial fibrillation.
- Hemodynamical instability, as defined by a variation in heart rate, blood pressure and cardiac output of more than 10% during the 15-min period before starting the protocol.
- Recent myocardial infarction (< 3 mnd, troponine > 50 ug/l).
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 |
|---|---|---|
| ventilatory protocolVentilatory protocol for short period with four different tidal volumes (12 min) | Other | Elective open heart surgery |
| Elastic bandPlacement of an elastic band around thorax to reduce thorax compliance | Other | Elective open heart surgery |
| passive leg raising testperforming the passive leg raising test | Other | Elective open heart surgery |
Primary outcome
fluid responsiveness
Time frame: 30 minutes around fluid challenge
pulse pressure variation (PPV), systolic pressure variation (SPV), stroke volume variation (SVV), pre-ejection period variation (dPEP)
4 secondary outcomes
Pressure distribution in thorax due to mechanical ventilation
Time frame: 30 minutes of varying tidal volumes
Dynamic indices in pressure support ventilation
Time frame: 30 minutes of pressure support
non invasive prediction of fluid responsiveness
Time frame: 30 minutes around fluid challenge
pressure distribution and dynamic indices during spontaneous breathing
Time frame: 5 minutes of spontaneous breathing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2010.
Related trials for Fluid Responsiveness
Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
Sepsis, Circulatory Instability
RecruitingObservational study
Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness
Hemodynamic Instability, Hypovolemia
RecruitingObservational study
Role of End-Tidal CO2 During Passive Leg Raising to Predict Fluid Responsiveness in ICU
Circulatory Failure, Critical Illness
Not yet recruitingObservational study
Capillary Refill Time Variation to Predict Oxygen Comsumption Variation After FLuid Challenge (CARTOFL)
Critically Ill Patients, Circulatory Shock
Not yet recruitingObservational study
Fluid Responsiveness in Laparoscopic Surgery: End-Expiratory Occlusion Test Versus Mini-Fluid Challenge
Fluid Responsiveness, Laparoscopic Surgery
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.
Peter Pickkers, MD, PhD contact
Benno Lansdorp, MSc. principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ventilatory protocol, Elastic band and passive leg raising test in people with Fluid Responsiveness, run by Radboud University Medical Center at 1 site in Netherlands.
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 1 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 31 Aug 2010. 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 Netherlands. 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 Peter Pickkers, MD, PhD (p.pickkers@ic.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fluid responsiveness (time frame: 30 minutes around fluid challenge). 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 31 Aug 2010.