NIRS and DO2i Correlation

Perfusion; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03281707
• Other study ID #: R627/17-CCM 662
• Status: Not yet recruiting
• Phase: N/A
• First received: September 11, 2017
• Last updated: September 11, 2017
• Start date: September 30, 2017
• Est. completion date: October 30, 2018

Study information

• Verified date: September 2017
• Source: Centro Cardiologico Monzino
• Contact: Luca Salvi, MD
• Phone: +390258002541
• Email: luca.salvi[@]ccfm.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 30, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Multiorgan Failure
• Multiple Organ Failure
• Perfusion; Complications

Intervention

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

Other:
• DO2i
Oxygen delivery standardized to the body surface area will be calculate in order to optimize tissue perfusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centro Cardiologico Monzino

References & Publications (4)

de Somer F, Mulholland JW, Bryan MR, Aloisio T, Van Nooten GJ, Ranucci M. O2 delivery and CO2 production during cardiopulmonary bypass as determinants of acute kidney injury: time for a goal-directed perfusion management? Crit Care. 2011 Aug 10;15(4):R192 — View Citation

Nielsen HB, Børglum J. Cerebral oxygenation in heart surgery. Anesth Analg. 2007 Aug;105(2):537; author reply 538-9. — View Citation

Ranucci M, Romitti F, Isgrò G, Cotza M, Brozzi S, Boncilli A, Ditta A. Oxygen delivery during cardiopulmonary bypass and acute renal failure after coronary operations. Ann Thorac Surg. 2005 Dec;80(6):2213-20. — View Citation

Vincent JL, Moreno R, Takala J, Willatts S, De Mendonça A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Proble — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the correlation between NIRS and DO2i during cardiac surgery		Intraoperative
Secondary	Evaluate the correlation between NIRS, DO2i and SOFA score		7 days postoperative