NIRS and DO2i Correlation

Sponsor

Centro Cardiologico Monzino (Other)

Overall Status

Unknown status

CT.gov ID

NCT03281707

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiorgan Failure Perfusion; Complications	Procedure: NIRS Other: DO2i

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Sep 30, 2017

Anticipated Primary Completion Date :

Oct 30, 2018

Anticipated Study Completion Date :

Oct 30, 2018

Outcome Measures

Primary Outcome Measures

Evaluate the correlation between NIRS and DO2i during cardiac surgery [Intraoperative]

Secondary Outcome Measures

Evaluate the correlation between NIRS, DO2i and SOFA score [7 days postoperative]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Centro Cardiologico Monzino

Investigators

Principal Investigator: Luca Salvi, MD, Centro Cardiologico Monzino

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

luca salvi, Anesthesia and ICU director, Centro Cardiologico Monzino

ClinicalTrials.gov Identifier:

NCT03281707

Other Study ID Numbers:

R627/17-CCM 662

First Posted:

Sep 13, 2017

Last Update Posted:

Sep 13, 2017

Last Verified:

Sep 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by luca salvi, Anesthesia and ICU director, Centro Cardiologico Monzino

NIRS

DO2

Additional relevant MeSH terms:

Multiple Organ Failure

Study Results

No Results Posted as of Sep 13, 2017