SepsisNCT03395951
Mean Systemic Filling Pressure Continuous Diuretics Critical Care Patients
An observational study of Sepsis and Heart Failure, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
Within clinical settings observation of hemodynamic changes (e.g. mean systemic filling pressure, cardiac output) in critically ill patients with a clinical indication for deresuscitation with intravenous diuretic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Heart Failure, Heart Diseases
- What is being tested?
- Diuretics
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2014to 31 Jan 2015
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients with a clinical indication for treatment with intravenous diuretics
Who may be able to join
- Patients must be at least 18 years
- PiCCO in situ (cardiac output device applied in light of clinical treatment)
- CVL in situ
- Clinical indication for continuous furosemide administration
Who cannot join
- Patients younger then 18 years
- Patients without PiCCO
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Observation of Mean Systemic Filling Pressure in Critical Care Patients With Continuous Diuretics Administration
Within clinical settings observation of hemodynamic changes (e.g. mean systemic filling pressure, cardiac output) in critically ill patients with a clinical indication for deresuscitation with intravenous diuretic therapy.
Read the detailed description
Rationale: The assessment of the cardiovascular state in critically ill patients is subject to difficulties in terms of the fact that several hemodynamic parameters, for example mean arterial blood pressure (MAP) and cardiac output (CO) supply insufficient information about the circulating volume and cardiac performance. There is a clinical need for adequate determination of intravascular volume status. However, in determining the intravascular fluid status of a patient, the lack of appreciation of the venous side of the circulation persists today, which is greatly due to the inability to appropriately assess the venous side of the circulation. The importance of the venous part of the circulation is moreover reflected by the fact that an increase in venous resistance does reduce CO many times more than a similar increase in arterial resistance. Mean systemic filling pressure (Pms), which is defined as the pressure equal to the pressure which would be measured if the heart should suddenly stop pumping and all (arterial and venous) the pressures in the entire circulatory system should be brought to equilibrium instantaneously, is a good, complete and reliable reflection of the total intravascular fluid compartment.
Positive fluid balance and /or substantial weight gain in critically ill patients is a common problem in the intensive care unit (ICU), potentially associated with a poor outcome. This problem, in association with hemodynamic instability and increase of creatinin, ureum and sodium, may lead to peripheral edema. Furosemide, a loop diuretic, is frequently administered to critically ill patients to increase urine output and to relieve edema.
Objective: Observing changes in Pms during continuous furosemide administration.
Study design: Prospective, observational study Study population: Patients with a PICCO® system with a positive fluid balance and / or substantial weight gain and therefore with a clinical indication for diuretic therapy.
Intervention: Continuous furosemide administration. Main study parameters/endpoints: Pms measured at baseline, changes in Pms during continuous furosemide administration.
Adverse events: No risks involved.
- Conditions
- Sepsis, Heart Failure, Heart Diseases, Septic Shock, Surgery, Critically Ill
- Being tested
- Diuretics
- Keywords
- Mean Systemic Filling Pressure, Diuretics, Pressure for venous return, Fluid Balance, De-escalation fluid therapy, De-resuscitation, Guyton, Guytonian Approach, Furosemide, Cardiac Output, Cardiac Index
- Medical subject headings
- Sepsis, Heart Failure, Heart Diseases, Shock, Septic, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiureticsDrug
Also called Diuretic therapy
Observation of hemodynamics during diuretics treatment within clinical indication.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean systemic filling pressure (mmHg)
Decrease or increase in mean systemic filling pressure measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device
Measured: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Secondary outcomes (17)
Change in cardiac index (L/min/m2)
Decrease/increase in cardiac index measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device
Measured: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Change in mean arterial pressure (mmHg)
Decrease/increase in mean arterial pressure measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device
Measured: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Change in central venous pressure (mmHg)
Decrease/increase in central venous pressure measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device
Measured: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Change in pressure for venous return (mmHg)
Decrease/increase in pressure for venous return measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device
Measured: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Change in resistance to venous return (dynes⋅sec⋅cm-5)
Decrease/increase in resistance te venous return measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device
Measured: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Change in systemic vascular resistance index (dynes⋅sec⋅cm-5)
Decrease/increase in systemic vascular resistance index measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device
Measured: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Change in venous return index (L/min/m2)
Decrease/increase in venous return index measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device
Measured: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Change in heart rate (bpm)
Decrease/increase in heart rate measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device
Measured: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Change in extra vascular lung water index (mL/kg)
Decrease/increase in extra vascular lung water index measured with continuous cardiac output monitoring PiCCO(R) device
Measured: Baseline and after 24 hours
Change in global end diastolic volume index (mL/m2)
Decrease/increase in global end diastolic volume index measured with continuous cardiac output monitoring PiCCO(R) device
Measured: Baseline and after 24 hours
Change in intrathoracic blood volume index (mL/m2)
Decrease/increase in intrathoracic blood volume index measured with continuous cardiac output monitoring PiCCO(R) device
Measured: Baseline and after 24 hours
Creatinin (renal function) mmol/L
Increase/decrease in creatinin (standard blood withdrawal within standard ICU treatment)
Measured: Baseline and after 24 hours
Electrolyte balance (potassium, sodium levels) (mmol/L)
Increase/decrease in electrolyte balance (potassium, sodium levels) (standard blood withdrawal within standard ICU treatment)
Measured: Baseline and after 24 hours
Diuresis per hour (mL/hour)
Increase/decrease in diuresis (standardly measured within standard ICU treatment)
Measured: Baseline, 1 hour, 2 hours and after 24 hours
Body weight (kg)
Increase/decrease in body weight (standardly measured within standard ICU treatment)
Measured: Baseline and after 24 hours
Fluid balance (mL)
Increase/decrease in fluid balance (mL) (standardly measured within standard ICU treatment)
Measured: Baseline and after 24 hours
Change in cardiac performance (eH) (dimensionless)
Increase/decrease in cardiac performance (eH)
Measured: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start1 Oct 2014
- Primary completion1 Oct 2014
- Study completion31 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center
- Responsible party
- Principal investigator, L.P.B. Meijs, Catharina Ziekenhuis Eindhoven
- Investigators
- Jan Bakker, MD, PhD, Study chair, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395951
- Sponsor's protocol ID
- n-WMO 2014-43
- Status last verified
- Dec 2019
- First submitted
- 1 Jan 2018
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Under negotiable conditions sharing of data can be discussed.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation of Mean Systemic Filling Pressure in Critical Care Patients With Continuous Diuretics Administration
- ClinicalTrials.gov ID
- NCT03395951
- Acronym / sponsor ID
- n-WMO 2014-43
- Conditions
- Sepsis, Heart Failure, Heart Diseases, Septic Shock, Surgery, Critically Ill
- Keywords
- Mean Systemic Filling Pressure, Diuretics, Pressure for venous return, Fluid Balance, De-escalation fluid therapy, De-resuscitation, Guyton, Guytonian Approach
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Collaborators
- Erasmus Medical Center
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 1 Oct 2014 (actual)
- Study completion
- 31 Jan 2015 (actual)
- First posted
- 10 Jan 2018 (actual)
- 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.
Within clinical settings observation of hemodynamic changes (e.g. mean systemic filling pressure, cardiac output) in critically ill patients with a clinical indication for deresuscitation with intravenous diuretic therapy.
Detailed description
Rationale: The assessment of the cardiovascular state in critically ill patients is subject to difficulties in terms of the fact that several hemodynamic parameters, for example mean arterial blood pressure (MAP) and cardiac output (CO) supply insufficient information about the circulating volume and cardiac performance. There is a clinical need for adequate determination of intravascular volume status. However, in determining the intravascular fluid status of a patient, the lack of appreciation of the venous side of the circulation persists today, which is greatly due to the inability to appropriately assess the venous side of the circulation. The importance of the venous part of the circulation is moreover reflected by the fact that an increase in venous resistance does reduce CO many times more than a similar increase in arterial resistance. Mean systemic filling pressure (Pms), which is defined as the pressure equal to the pressure which would be measured if the heart should suddenly stop pumping and all (arterial and venous) the pressures in the entire circulatory system should be brought to equilibrium instantaneously, is a good, complete and reliable reflection of the total intravascular fluid compartment.
Positive fluid balance and /or substantial weight gain in critically ill patients is a common problem in the intensive care unit (ICU), potentially associated with a poor outcome. This problem, in association with hemodynamic instability and increase of creatinin, ureum and sodium, may lead to peripheral edema. Furosemide, a loop diuretic, is frequently administered to critically ill patients to increase urine output and to relieve edema.
Objective: Observing changes in Pms during continuous furosemide administration.
Study design: Prospective, observational study Study population: Patients with a PICCO® system with a positive fluid balance and / or substantial weight gain and therefore with a clinical indication for diuretic therapy.
Intervention: Continuous furosemide administration. Main study parameters/endpoints: Pms measured at baseline, changes in Pms during continuous furosemide administration.
Adverse events: No risks involved.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients with a clinical indication for treatment with intravenous diuretics
Key inclusion criteria (4 listed)
- Patients must be at least 18 years
- PiCCO in situ (cardiac output device applied in light of clinical treatment)
- CVL in situ
- Clinical indication for continuous furosemide administration
Key exclusion criteria (3 listed)
- Patients younger then 18 years
- Patients without PiCCO
- Pregnant women
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 |
|---|---|---|
| DiureticsAlso: Diuretic therapyObservation of hemodynamics during diuretics treatment within clinical indication. | Drug | – |
Primary outcome
Change in mean systemic filling pressure (mmHg)
Time frame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Decrease or increase in mean systemic filling pressure measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device
17 secondary outcomes
Change in cardiac index (L/min/m2)
Time frame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Change in mean arterial pressure (mmHg)
Time frame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Change in central venous pressure (mmHg)
Time frame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Change in pressure for venous return (mmHg)
Time frame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Change in resistance to venous return (dynes⋅sec⋅cm-5)
Time frame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Change in systemic vascular resistance index (dynes⋅sec⋅cm-5)
Time frame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Change in venous return index (L/min/m2)
Time frame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Change in heart rate (bpm)
Time frame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Change in extra vascular lung water index (mL/kg)
Time frame: Baseline and after 24 hours
Change in global end diastolic volume index (mL/m2)
Time frame: Baseline and after 24 hours
Change in intrathoracic blood volume index (mL/m2)
Time frame: Baseline and after 24 hours
Creatinin (renal function) mmol/L
Time frame: Baseline and after 24 hours
Electrolyte balance (potassium, sodium levels) (mmol/L)
Time frame: Baseline and after 24 hours
Diuresis per hour (mL/hour)
Time frame: Baseline, 1 hour, 2 hours and after 24 hours
Body weight (kg)
Time frame: Baseline and after 24 hours
Fluid balance (mL)
Time frame: Baseline and after 24 hours
Change in cardiac performance (eH) (dimensionless)
Time frame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Individual participant dataSharing planned: Yes. Under negotiable conditions sharing of data can be discussed.
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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.
Jan Bakker, MD, PhD study chair
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Heart Failure, run by Catharina Ziekenhuis Eindhoven 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 4 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: finished, as of the sponsor's last update on 18 Dec 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in mean systemic filling pressure (mmHg) (time frame: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours). 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 18 Dec 2019.