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Status unknownNCT03281707Updated Sep 13, 2017

NIRS and DO2i Correlation

An observational study in Multiorgan Failure and Perfusion; Complications, sponsored by Centro Cardiologico Monzino. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-13.

Sponsored by Centro Cardiologico Monzino · Observational

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Multiorgan Failure
  • Perfusion; Complications

Keywords

  • NIRS
  • DO2
03

In context

Multiple Organ Failure

193 studies on the registry are indexed under Multiple Organ Failure; 47 are open to participants now.

This study's planned enrollment of 50 is below the median of 200 across 94 observational studies indexed under Multiple Organ Failure.

Browse Multiple Organ Failure studies →

Lead sponsor

Centro Cardiologico Monzino is the lead sponsor of 72 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing cardiac surgery

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Impossibilty to collect a correct continuous cardiac output measure with PiCCO (chronic atrial fibrillation or severe peripheral vasculopaty)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Target follow-up
7 Days
Patient registry
Yes

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

06

What researchers measure

Primary outcomes

  1. Evaluate the correlation between NIRS and DO2i during cardiac surgery

    Time frame: Intraoperative

Secondary outcomes

  1. Evaluate the correlation between NIRS, DO2i and SOFA score

    Time frame: 7 days postoperative

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 16305874 ↗
  • 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. PubMed 21831302 ↗
  • 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. PubMed 17646526 ↗
  • 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. PubMed 8844239 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2017; primary completion for Oct 2018, 13 months later.

Of 44 non-industry observational studies under Multiple Organ Failure, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's planned 13 months is below that.

Counting every sponsor, half of 44 studies reached it within 32 months; a quarter within 16 and three quarters within 69.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2017
First posted
Sep 13, 2017
StartEst.
Sep 30, 2017
Primary completionEst.
Oct 30, 2018
CompletionEst.
Oct 30, 2018
Last update
Sep 13, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03281707
Lead sponsor
Centro Cardiologico Monzino
Responsible party
luca salvi (Anesthesia and ICU director, Centro Cardiologico Monzino) — Principal investigator
First posted
Sep 13, 2017
Start date
Sep 30, 2017 (estimated)
Primary completion
Oct 30, 2018 (estimated)
Completion
Oct 30, 2018 (estimated)
Last update
Sep 13, 2017

Study contacts

Luca Salvi, MD
Contact
luca.salvi@ccfm.it
+390258002541
Matteo Nafi, MD
Contact
matteo.nafi@ccfm.it
+390258002879
Luca Salvi, MD
principal investigator · Centro Cardiologico Monzino

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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