Mean Systemic Filling Pressure and Heart Performance Predicting Fluid Responsiveness in Aortic Valve Replacement

NCT02778620 | Completed

• 1 other identifier: M12-1270
• Study Type: observational
• Target: 27
• 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)

• Heart Rate

  1 hour

• MAP

  1 hour

• CI

  1 hour

Study Arms (1)

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.

Eligibility Criteria

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

Study Population

Post-aortic valve replacement patients

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

Location

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

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: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: December 18, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)