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NCT01891188

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

Completed Last updated 23 January 2026
What this trial tests

trial in Congenital Heart Disease in 100 participants. Completed in 1 July 2016.

Timeline
1 June 2013
Primary endpoint
1 June 2016
1 July 2016

Quick facts

Lead sponsorPhoenix Children's Hospital
StatusCompleted
Study typeOBSERVATIONAL
Enrollment100
Start date1 June 2013
Primary completion1 June 2016
Estimated completion1 July 2016
Sites1 location across United States

Conditions studied

Sponsor

Phoenix Children's Hospital

Who can join

Adults 1 Day to 18, any sex, with Congenital Heart Disease or Arrhythmia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Congenital Heart Disease

Currently open trials in the same condition.

Other Phoenix Children's Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01891188.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing