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Completed

NCT Number: NCT01891188

Using Near-infrared Spectroscopy (NIRS) Monitor to Noninvasively Evaluate Hepatic Venous Saturation

Clinical studies are required to validate the hepatic NIRS monitor with other regional and global hemodynamic parameters and to evaluate its clinical use for continuous non-invasive hemodynamic monitoring. Using newer NIRS sensors the correlation between hepatic regional oxygen saturation and hepatic venous oxygen saturation (SvHO2) needs to be determined. If found to correlate then the NIRS can be used to evaluate early liver transplant failure and/or hepatic artery thrombosis, used as an early marker for shock, and necrotizing enterocolitis, and finally used in the outpatient setting to evaluate patients with chronic liver pathologies. If our validation study finds that NIRS monitors are an appropriate marker of hepatic venous saturation then it will lead to further clinical studies.

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Key information

Conditions

Congenital Heart Disease Arrhythmia Arrhythmias, Cardiac Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All pediatric patients (0-18yrs) undergoing cardiac catheterization by the participating interventional cardiologist at Phoenix Children's Hospital will be recruited for this investigation

Exclusion criteria

  • emergency catheterizations,
  • procedures in hemodynamically unstable patients,
  • patients with repeat catheterizations that have already enrolled in the study

Treatment and study plan

Primary outcomes

  1. Degree of Hepatic Venous Saturation using NIRS

    Time frame: 5 minutes

    The investigators strive to discover a noninvasive measure of hepatic venous saturation. The use of NIRS monitoring for global oxygen saturation has been used in the inpatient population. This project aims to use hepatic NIRS monitor as a surrogate marker for hepatic and splanchnic oxygenation.

Sponsors and collaborators

Lead sponsor

Phoenix Children's Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 3, 2013
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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