- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02778620
Mean Systemic Filling Pressure and Heart Performance Predicting Fluid Responsiveness in Aortic Valve Replacement
December 16, 2019 updated by: L.P.B. Meijs, Catharina Ziekenhuis Eindhoven
Mean Systemic Filling Pressure and Heart Performance as Predictors of Successful Fluid Responsiveness in Patients With Aortic Valve Replacement
The purpose of this study is to determine fluid responsiveness in critically ill patients by measuring mean systemic filling pressure on the intensive care unit.
Study Overview
Status
Completed
Conditions
Detailed Description
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 to adequate determination of intravascular volume status and therefore reliable predictors of fluid responsiveness are highly relevant.
However, in determining the 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.
Passive leg raising (PLR) represents a "self-volume challenge" that predicts preload responsiveness and the transient hemodynamic changes on venous return can be directly monitored in ventilated patients, provided that there is an intact circulation, in order to test the amount of volume responsiveness.
Study Type
Observational
Enrollment (Actual)
27
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Brabant
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Eindhoven, North Brabant, Netherlands, 5623 EJ
- Catharina hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Post-aortic valve replacement patients
Description
Inclusion Criteria:
- Patients must be older than 18 years, and must be equipped with a pulse-contour cardiac output system with a central venous catheter.
- Patients will be subsequently connected to the hemodynamic monitoring device Navigator™.
- In those patients with clinical signs of inadequate tissue perfusion, passive leg raising and standardized fluid challenge will be performed.
Exclusion Criteria:
- Patients with assist devices (e.g. intra aortic balloon pump, Impella®, ECMO), patients with arrhythmias (either atrial of ventricular) will be excluded from the study.
- Also, patients with inguinal impairment or contraindications for a passive leg raising will be excluded (such as deep venous thrombosis or elastic compression stocking), head trauma, an increase intra-abdominal pressure suspected by clinical context and examination as well as patients with absolute contraindications for fluid challenge.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Aortic Valve Replacement
Post Anaesthetic Care Unit (PACU) patients treated with aortic valve replacement (AVR) are highly eligible for this study.These are patients with an indication for fast track treatment (PACU) post-cardiac surgery with a good left ventricular ejection fraction without significant co-morbidity.
The final decision for PACU-classification is taken by the responsible anaesthesiologist and intensivist in close collaboration with the cardiothoracic surgeon performing the operation, as well as the cardiologist.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean systemic filling pressure (Pms)
Time Frame: 1 hour
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An increase in mean systemic filling pressure after (self)volume-challenge indicating volume responsiveness of the patient
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart performance (eH)
Time Frame: 1 hour
|
Quotient of driving pressure of venous return in mmHg
|
1 hour
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart Rate
Time Frame: 1 hour
|
Heart Rate in bpm
|
1 hour
|
MAP
Time Frame: 1 hour
|
Mean Arterial Blood Pressure
|
1 hour
|
CI
Time Frame: 1 hour
|
Cardiac Index
|
1 hour
|
CVP
Time Frame: 1 hour
|
Central Venous Pressure
|
1 hour
|
SVR
Time Frame: 1 hour
|
Systemic Vascular Resistance
|
1 hour
|
PPV
Time Frame: 1 hour
|
Pulse Pressure Variation
|
1 hour
|
PVPI
Time Frame: 1 hour
|
Pulmonary Vascular Permeability Index
|
1 hour
|
pO2
Time Frame: 1 hour
|
Plethysmographic Oxygen Saturation
|
1 hour
|
DO2I
Time Frame: 1 hour
|
Delivery of Oxygen Index
|
1 hour
|
Ventilation
Time Frame: 1 hour
|
Mechanical Ventilation Settings
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1 hour
|
etCO2
Time Frame: 1 hour
|
End-tidal CO2
|
1 hour
|
Temp perif
Time Frame: 1 hour
|
Peripheral Temperature
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
May 18, 2016
First Submitted That Met QC Criteria
May 19, 2016
First Posted (Estimate)
May 20, 2016
Study Record Updates
Last Update Posted (Actual)
December 18, 2019
Last Update Submitted That Met QC Criteria
December 16, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M12-1270
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
No, data remain anonymized within hospital and property of PI.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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