EARLY DETECTION OF SHOCK IN CRITICALLY ILL NEWBORN INFANTS. The impact of advanced hemodynamic monitoring

Completed

• Conditions: circulatory failure; Shock; 10019280; 10028920

• Registration Number: NL-OMON37793
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 112

Inclusion Criteria

- Birth weight >=700 grams
- Arterial catheter in place, well functioning with tip adequately positioned in abdominal aorta (umbilical catheter), radial artery or posterior tibial artery
- Central venous catheter in place, non-silicone, well functioning with tip adequately positioned on the junction between right atrium and inferior vena cava or superior vena cava (multi-lumen, when a pause in the continuous intravenous administration of drugs (for example inotropes or vasopressors) is not possible; single-lumen, when the continuous administration of drugs can be stopped for the period of cardiac output measurements, approximately 5-6 minutes)
- Informed consent obtained from parents or representatives

Exclusion Criteria

- Infants not meeting eligibility criteria
- Life-threatening congenital defects
- Congenital heart defects, except for patent ductus arteriosus and patent foramen ovale.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Timing (postnatal age) of diagnosis of circulatory failure (shock)<br /><br>2. Agreement between objective cardiac output assessment by transpulmonary<br /><br>ultrasound dilution (TPUD) and simultaneously clinically estimated cardiac<br /><br>output (absolute and categorical)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Other hemodynamic parameters that will be analyzed are:<br /><br>- regional oxygen saturation at the level of the brain, kidney, intestines and<br /><br>muscle<br /><br>- arterial blood pressure<br /><br>- heart rate<br /><br>- arterial oxygen saturation<br /><br>- hemodynamic volumetry</p><br>