Mean Systemic Filling Pressure and Heart Performance Predicting Fluid Responsiveness in Sepsis

Mean Systemic Filling Pressure and Heart Performance as Predictors of Successful Fluid Responsiveness in Patients With Sepsis

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: Unknown
• Conditions: Cardiac Output, High

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 (Anticipated): 20

Contacts and Locations

• Study Contact: Name: LPB Meijs, MD; Phone Number: 00312399111; Email: Loek.Meijs@catharinaziekenhuis.nl
• Study Contact Backup: Name: LPB Meijs, MD; Phone Number: 0031-40-2399111; Email: Loek.Meijs@catharinaziekenhuis.nl

Study Locations

• Netherlands
  • North Brabant
    • Eindhoven, North Brabant, Netherlands, 5623 EJ
      • Recruiting
      • Catharina Hospital
      • Contact: L.P.B. Meijs, MD; Phone Number: 0031-40-2399111; Email: loek.meijs@catharinaziekenhuis.nl
      • Contact: A.J.G.H. Bindels, PhD; Phone Number: 0031-40-2399111; Email: Alex.Bindels@catharinaziekenhuis.nl
      • Principal Investigator: Loek Meijs, MD
      • Principal Investigator: A.J.G.H. Bindels, PhD
      • Sub-Investigator: A. Roos, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Septic patients on ICU

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Sepsis; Patients diagnosed with septic shock, admitted to the intensive care unit, with a good left ventricular ejection fraction without significant co-morbidity are highly eligible for this study. Patients must be equipped with a pulse-contour cardiac output (PICCO)-system with a central venous catheter which will be applied by the intensivist on admission.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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean systemic filling pressure (Pms)	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)	Quotient of driving pressure of venous return in mmHg	1 hour

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Catharina Ziekenhuis Eindhoven
• Collaborators: Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): December 1, 2019

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): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Volume responsiveness mean systemic filling pressure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiac Output, High
• Other Study ID Numbers: M12-1272

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.