Overview

This trial is active, not recruiting.

Conditions congenital heart disease, arrhythmia
Sponsor Phoenix Children's Hospital
Start date June 2013
End date June 2016
Trial size 100 participants
Trial identifier NCT01891188, PHNX-hNIRS-12-120

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
All pediatric patients requiring cardiac catheterization who consent

Primary Outcomes

Measure
Degree of Hepatic Venous Saturation using NIRS
time frame: 5 minutes

Eligibility Criteria

Male or female participants up to 18 years old.

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

Additional Information

Official title Using Near-infrared Spectroscopy (NIRS) Monitor to Noninvasively Evaluate Hepatic Venous Saturation
Principal investigator Rohit Rao, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Phoenix Children's Hospital.