Functional Hemodynamic Assessment in Shocked Patients in the Pediatric Intensive Care Unit

December 3, 2024 updated by: Osman Gamal Hassan, Assiut University
is to assess Functional hemodynamic status in shocked patients in the Pediatric Intensive Care Unit

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Shock is a leading cause of morbidity and mortality in pediatric patients worldwide (1, 2). The prevalence of sepsis and septic shock has been reported to be around 1-26% of shock cases with mortality rates ranging from 5 to 35% in hospitalized children globally (3, 4).

Appropriate fluid resuscitation is crucial in the management of children with shock (5). The current American College of Critical Care Medicine (ACCM), Pediatric Advanced Life Support (PALS), and Surviving Sepsis Campaign Guidelines have focused on the implementation of early and goal-directed fluid therapy (6, 7). Many studies have shown that mortality in pediatric patients with septic shock has been significantly decreased with aggressive fluid administration (8, 9). However, overzealous fluid administration can also lead to fluid overload (FO) and has been associated with complications such as acute respiratory distress syndrome (ARDS), which results in poor outcomes including increased hospital length of stay and mechanical ventilator days (10-13). As a result, in the recent decades, a more restrictive approach for fluid resuscitation has emerged in adults and children vs. the usual aggressive fluid therapy (14-16).

Traditional use of subjective findings such as pulse volume, capillary refill time, and clinical signs of hydration status to predict fluid responsiveness (FR) has been proven to be unreliable (17, 18).

While there is a growing body of the literature on the use of non-invasive devices for objective hemodynamic monitoring, there is a paucity of the literature related to the assessment of FR using these measures in children with shock (19).

Noninvasive monitoring techniques for the assessment of various cardiovascular parameters are increasingly accepted as the current medical practice. Electrical cardiometry (EC) is one such method for the determination of stroke volume (SV), cardiac output (CO), and other hemodynamic parameters and is based on changes in electrical conductivity within the thorax (20).

ICON® based on Electrical Cardiometry™ (EC) technology (Osypka Medical GmbH, Berlin, Germany) is a noninvasive, continuous hemodynamic monitoring device. It determines the CO by measuring variations in the thoracic electrical bioimpedance with phases of a cardiac cycle. During diastole, the erythrocytes in the aorta assume a random orientation (more impedance), while during systole the pulsatile blood flow causes them to align parallel to both the blood flow and the electrical current (less impedance). The magnitude of the maximum rate of change of impedance with a change in the orientation of erythrocytes gives a peak aortic blood flow acceleration and stroke volume (21).

Cardiac index (CI), systemic vascular resistance index (SVRI), cardiac contractility, stroke volume variation (SVV) and thoracic fluid content (TFC) are derived using complex mathematical formulae and patented algorithms. The accuracy and the clinical utility of electrocardiometry have been validated against other measures of CO like direct Fick' s method, thermodilution, and transthoracic and transesophageal echocardiography in a wide spectrum of patient conditions and populations across all ages, including critically ill patients, intraoperative settings, cardiac catheterization, and congenital heart diseases (22-26).

Study Type

Observational

Enrollment (Estimated)

129

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

shocked patients of age above one month and below 18 years

Description

Inclusion Criteria:

  • Children aged between 1 month and 18 years admitted to PICU with shock state
  • Critically ill child who needs continuous hemodynamic monitoring in PICU

Exclusion Criteria:

  • Age below one month of age and above 18 years
  • Postoperative patients

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional hemodynamic assessment in shocked patients in the Pediatric Intensive Care Unit
Time Frame: baseline
is to assess the need for fluid boluses administration in patients with shock
baseline

Collaborators and Investigators

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

Sponsor

Assiut University

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 (Estimated)

January 1, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

December 3, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Estimated)

December 6, 2024

Study Record Updates

Last Update Posted (Estimated)

December 6, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • assessment of shocked patients

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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