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

NCT02778633 | Unknown

• 1 other identifier: M12-1272
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Output, High

Keywords

Volume responsiveness mean systemic filling pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Heart performance (eH)

  1 hour

Other Outcomes (12)

• Secondary hemodynamic parameters

  1 hour

• Secondary hemodynamic parameters

  1 hour

• Secondary hemodynamic parameters

  1 hour

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Septic patients on ICU

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead
• Erasmus Medical Center: collaborator

Study Sites (1)

Catharina Hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

RECRUITING

MeSH Terms

Conditions

Cardiac Output, High

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan Bakker, MD, PhD

  Erasmus Medical Center

  STUDY CHAIR

Central Study Contacts

LPB Meijs, MD

CONTACT

00312399111; Loek.Meijs@catharinaziekenhuis.nl

LPB Meijs, MD

CONTACT

0031-40-2399111; Loek.Meijs@catharinaziekenhuis.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD-candidate Intensive Care Unit / resident cardiology

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: May 20, 2016
• Study Start: August 1, 2013
• Primary Completion: May 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 25, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)