Mean Systemic Filling Pressure and Heart Performance Predicting Fluid Responsiveness

May 18, 2016 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 Coronary Artery Bypass Grafting

Determining fluid responsiveness in critically ill patients by measuring mean systemic filling pressure on the intensive care unit.

Study Overview

Status

Completed

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)

40

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
      • Eindhoven, North Brabant, Netherlands, 5623 EJ
        • Catharina Hospital

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

Coronary artery bypass grafting, aortic valve replacement and septic shock 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

Cohorts and Interventions

Group / Cohort
Coronary artery bypass grafting
Post Anaesthetic Care Unit (PACU) patients treated with coronary artery bypass grafting (CABG) 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean systemic filling pressure (Pms)
Time Frame: 1 hour
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
Secondary hemodynamic parameters
Time Frame: 1 hour
Heart Rate
1 hour
Secondary hemodynamic parameters
Time Frame: 1 hour
Mean Arterial Blood Pressure
1 hour
Secondary hemodynamic parameters
Time Frame: 1 hour
Cardiac Index
1 hour
Secondary hemodynamic parameters
Time Frame: 1 hour
Central Venous Pressure
1 hour
Secondary hemodynamic parameters
Time Frame: 1 hour
Systemic Vascular Resistance
1 hour
Secondary hemodynamic parameters
Time Frame: 1 hour
Pulse Pressure Variation
1 hour
Secondary hemodynamic parameters
Time Frame: 1 hour
Pulmonary Vascular Permeability Index
1 hour
Secondary hemodynamic parameters
Time Frame: 1 hour
Plethysmographic Oxygen Saturation
1 hour
Secondary hemodynamic parameters
Time Frame: 1 hour
Delivery of Oxygen Index
1 hour
Secondary hemodynamic parameters
Time Frame: 1 hour
Mechanical Ventilation Settings
1 hour
Secondary hemodynamic parameters
Time Frame: 1 hour
End-tidal CO2
1 hour
Secondary hemodynamic parameters
Time Frame: 1 hour
Peripheral Temperature
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Chair: Jan Bakker, PhD, Erasmus University Hospital Rotterdam The Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 23, 2013

First Submitted That Met QC Criteria

February 11, 2014

First Posted (ESTIMATE)

February 12, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

May 19, 2016

Last Update Submitted That Met QC Criteria

May 18, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • M12-1271

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.

Clinical Trials on Cardiac Output, High

3
Subscribe