NCT03281707

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

September 30, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
Last Updated

September 13, 2017

Status Verified

September 1, 2017

Enrollment Period

1.1 years

First QC Date

September 11, 2017

Last Update Submit

September 11, 2017

Conditions

Multiorgan FailurePerfusion; Complications

Keywords

NIRSDO2

Outcome Measures

Primary Outcomes (1)

  • Evaluate the correlation between NIRS and DO2i during cardiac surgery

    Intraoperative

Secondary Outcomes (1)

  • Evaluate the correlation between NIRS, DO2i and SOFA score

    7 days postoperative

Interventions

NIRSPROCEDURE

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

DO2iOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing cardiac surgery

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Ranucci M, Romitti F, Isgro 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. doi: 10.1016/j.athoracsur.2005.05.069.

    PMID: 16305874RESULT

  • 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. doi: 10.1186/cc10349.

    PMID: 21831302RESULT

  • Nielsen HB, Borglum J. Cerebral oxygenation in heart surgery. Anesth Analg. 2007 Aug;105(2):537; author reply 538-9. doi: 10.1213/01.ane.0000265698.02800.d4. No abstract available.

    PMID: 17646526RESULT

  • Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca 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 Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.

    PMID: 8844239RESULT

MeSH Terms

Conditions

Multiple Organ Failure

Condition Hierarchy (Ancestors)

ShockPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Luca Salvi, MD

    Centro Cardiologico Monzino

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca Salvi, MD

CONTACT

+390258002541luca.salvi@ccfm.it

Matteo Nafi, MD

CONTACT

+390258002879matteo.nafi@ccfm.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesia and ICU director

Study Record Dates

First Submitted

September 11, 2017

First Posted

September 13, 2017

Study Start

September 30, 2017

Primary Completion

October 30, 2018

Study Completion

October 30, 2018

Last Updated

September 13, 2017

Record last verified: 2017-09