NIRS and DO2i Correlation

Evaluation of NIRS and DO2i Correlation and Their Relationship With Organ Failure During Cardiac Surgery: a Prospective Monocentric Study.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03281707

Enrollment

Registered

2017-09-13

Start date

2017-09-30

Completion date

2018-10-30

Last updated

2017-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiorgan Failure, Perfusion; Complications

Keywords

NIRS, DO2

Brief summary

This study evaluates the association between near infrared spectroscopy (NIRS) and indexed oxygen delivery (DO2i) and their possible correlation with postoperative organ failure.

Detailed description

Literature evidences show that levels of DO2i under 262-272 mL/min/m2 during cardiopulmonary by-pass (CPB) are associated with an increased incidence of acute kidney injury (AKI). Furthermore, it has been demonstrated that keeping a NIRS of 75-80% compared to the basal value reduces the risk of perioperative morbidity. On the other hand, a NIRS \< 50% of basal value seems to be predictive of an increase in morbidity. All of those studies had been performed during CPB and knowledge lacks in management of DO2i and NIRS before and after CPB.

Interventions

PROCEDURENIRS

NIRS devices patch will be applied on patients' head in order to measure the cerebral saturation of each cerebral emisphere

OTHERDO2i

Oxygen delivery standardized to the body surface area will be calculate in order to optimize tissue perfusion

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* All patients undergoing cardiac surgery with cardiopulmonary by-pass whose have been signed the consent informed

Exclusion criteria

* Impossibilty to collect a correct continuous cardiac output measure with PiCCO (chronic atrial fibrillation or severe peripheral vasculopaty)

Design outcomes

Primary

Measure	Time frame
Evaluate the correlation between NIRS and DO2i during cardiac surgery	Intraoperative

Secondary

Measure	Time frame
Evaluate the correlation between NIRS, DO2i and SOFA score	7 days postoperative

Contacts

Primary ContactLuca Salvi, MD

luca.salvi@ccfm.it+390258002541

Backup ContactMatteo Nafi, MD

matteo.nafi@ccfm.it+390258002879

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026