Multiorgan FailureNCT03281707
NIRS and DO2i Correlation
An observational study of Multiorgan Failure and Perfusion; Complications, run by Centro Cardiologico Monzino.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiorgan Failure, Perfusion; Complications
- What is being tested?
- NIRS and DO2i
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2017to 30 Oct 2018
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cardiac surgery
Who may be able to join
- All patients undergoing cardiac surgery with cardiopulmonary by-pass whose have been signed the consent informed
Who cannot join
- Impossibilty to collect a correct continuous cardiac output measure with PiCCO (chronic atrial fibrillation or severe peripheral vasculopaty)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of NIRS and DO2i Correlation and Their Relationship With Organ Failure During Cardiac Surgery: a Prospective Monocentric Study.
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.
- Conditions
- Multiorgan Failure, Perfusion; Complications
- Being tested
- NIRS, DO2i
- Keywords
- NIRS, DO2
- Medical subject headings
- Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRSProcedure or surgery
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the correlation between NIRS and DO2i during cardiac surgery
Measured: Intraoperative
Secondary outcomes (1)
Evaluate the correlation between NIRS, DO2i and SOFA score
Measured: 7 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start30 Sep 2017 (estimated)
- Primary completion30 Oct 2018 (estimated)
- Study completion30 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiorgan FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, luca salvi, Centro Cardiologico Monzino
- Investigators
- Luca Salvi, MD, Principal investigator, Centro Cardiologico Monzino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281707
- Sponsor's protocol ID
- R627/17-CCM 662
- Status last verified
- Sep 2017
- First submitted
- 11 Sep 2017
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 16305874de 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 21831302Nielsen 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 17646526Vincent 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of NIRS and DO2i Correlation and Their Relationship With Organ Failure During Cardiac Surgery: a Prospective Monocentric Study.
- ClinicalTrials.gov ID
- NCT03281707
- Acronym / sponsor ID
- R627/17-CCM 662
- Conditions
- Multiorgan Failure, Perfusion; Complications
- Keywords
- NIRS, DO2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Study start
- 30 Sep 2017 (estimated)
- Primary completion
- 30 Oct 2018 (estimated)
- Study completion
- 30 Oct 2018 (estimated)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac surgery
Key inclusion criteria (1 listed)
- All patients undergoing cardiac surgery with cardiopulmonary by-pass whose have been signed the consent informed
Key exclusion criteria (1 listed)
- Impossibilty to collect a correct continuous cardiac output measure with PiCCO (chronic atrial fibrillation or severe peripheral vasculopaty)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIRSNIRS devices patch will be applied on patients' head in order to measure the cerebral saturation of each cerebral emisphere | Procedure or surgery | – |
| DO2iOxygen delivery standardized to the body surface area will be calculate in order to optimize tissue perfusion | Other | – |
Primary outcome
Evaluate the correlation between NIRS and DO2i during cardiac surgery
Time frame: Intraoperative
1 secondary outcome
Evaluate the correlation between NIRS, DO2i and SOFA score
Time frame: 7 days postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Results publication: PubMed 16305874Ranucci 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.
- Results publication: PubMed 21831302de 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.
- Results publication: PubMed 17646526Nielsen 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.
- Results publication: PubMed 8844239Vincent 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Salvi, MD principal investigator
Centro Cardiologico Monzino
Questions about this trial
What is this clinical trial studying?
An observational study of Multiorgan Failure and Perfusion; Complications, run by Centro Cardiologico Monzino.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luca Salvi, MD (+390258002541, luca.salvi@ccfm.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the correlation between NIRS and DO2i during cardiac surgery (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03281707, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2017.