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

Cardiac Output, High Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02778633
• Other study ID #: M12-1272
• Status: Recruiting
• Phase: N/A
• First received: May 18, 2016
• Last updated: January 23, 2018
• Start date: August 2013
• Est. completion date: December 2019

Study information

• Verified date: January 2018
• Source: Catharina Ziekenhuis Eindhoven
• Contact: LPB Meijs, MD
• Phone: 00312399111
• Email: Loek.Meijs[@]catharinaziekenhuis.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Output, High

Locations

Country	Name	City	State
Netherlands	Catharina Hospital	Eindhoven	North Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven	Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Secondary hemodynamic parameters	Heart Rate	1 hour
Other	Secondary hemodynamic parameters	Mean Arterial Blood Pressure	1 hour
Other	Secondary hemodynamic parameters	Cardiac Index	1 hour
Other	Secondary hemodynamic parameters	Central Venous Pressure	1 hour
Other	Secondary hemodynamic parameters	Systemic Vascular Resistance	1 hour
Other	Secondary hemodynamic parameters	Pulse Pressure Variation	1 hour
Other	Secondary hemodynamic parameters	Pulmonary Vascular Permeability Index	1 hour
Other	Secondary hemodynamic parameters	Plethysmographic Oxygen Saturation	1 hour
Other	Secondary hemodynamic parameters	Delivery of Oxygen Index	1 hour
Other	Secondary hemodynamic parameters	Mechanical Ventilation Settings	1 hour
Other	Secondary hemodynamic parameters	End-tidal CO2	1 hour
Other	Secondary hemodynamic parameters	Peripheral Temperature	1 hour
Primary	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	Heart performance (eH)	Quotient of driving pressure of venous return in mmHg	1 hour