Continuous Lactate MeasurementsCLM-CARDNCT02568969
Lactate in High-risk Cardiac Surgery
A study testing Eirus continuous lactate monitor in people with Continuous Lactate Measurements and Cardiosurgery, run by Northern State Medical University at 1 site in Russia.
Trial summary
The major combined interventions are between challenging and high-risk aspects of current cardiosurgical practice. The results of operation may be hampered by unexpected anatomic and technical features influencing the surgical approach as well as cardiopulmonary bypass (CPB), anesthesia, and respiratory support. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Continuous Lactate Measurements, Cardiosurgery
- What is being tested?
- Eirus continuous lactate monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteRussia
- Study dates
- Mar 2015to Nov 2015
- Phase
- Interventional
- 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
Who may be able to join
- Informed consent.
- Age above 18 years.
- Presence of coronary artery disease and/or valve regurgitation and/or stenosis
- Elective complex (two and more valves) and combined (valve + CABG) cardiac surgery requiring CPB with expected duration > 90 min.
Who cannot join
- Participation in any other study.
- Morbid obesity (BWI > 40).
Trial locations and contacts
1 site in 1 country.
Russia1 site
City hospital # 1 / Northern State Medical University,
Arkhangelsk, 163001
About this study
Official title: Continuous Monitoring of Lactate in High-risk Cardiac Surgery
The major combined interventions are between challenging and high-risk aspects of current cardiosurgical practice. The results of operation may be hampered by unexpected anatomic and technical features influencing the surgical approach as well as cardiopulmonary bypass (CPB), anesthesia, and respiratory support.
Plasma lactate concentration is a routine clinical indicator of the tissue oxygen shortage, and is routinely monitored in virtually all in-risk surgical and ICU patients. However, the discrete measurement of these values among with other biochemical values has a major drawback and continuous measurement can be beneficial.
The aim of our study is to assess the clinical usefulness and rationale for routine use of continuous monitoring of lactate in high-risk combined/complex cardiac surgery.
Read the detailed description
The combination of coronary artery bypass grafting (CABG), repair of valve pathology and/or valve replacement remains a challenging and high-risk aspect of current cardiosurgical practice. Direct and indirect results of surgery are affected by the variety of factors including patient's age, general condition, preoperative severity of heart dysfunction and remodeling, etc. In addition, the results of operation may be hampered by unexpected anatomic and technical features influencing the surgical approach as well as duration of cardiopulmonary bypass (CPB) and aortic cross clamping, anesthesia, intensive care and respiratory support.
The combined and complex cardiac surgery requires CPB, which, in parallel with increased duration of intervention, induces systemic inflammatory response and ischemia-reperfusion injury. These pathophysiological mechanisms include activation of cytokines, complement, neutrophils, monocytes, endothelium and platelets. Neutrophil sequestration in the vital organs in response to chemotaxis and release of reactive oxygen species and inflammatory mediators may result in tissue hypoperfusion and multiple organ dysfunction syndrome, contributing to development of postoperative complications and adverse outcomes.
To alleviate CPB-induced systemic inflammatory response and organ-specific injury, different interventions exist, including meticulous hemodynamic and metabolic monitoring followed by goal-directed therapy. Several recent studies from our group and other authors have clearly demonstrated the beneficial effects of such an approach in cardiac surgery. In these settings, when the extraction of O2 on cellular level may be severely disturbed, the complex analysis of changes in tissue perfusion and oxygenation before adjusting the therapy may be useful.
Current technique of continuous monitoring of lactate using Eirus system has a potential to broaden our knowledge in this clinical scenario and reinforce a decision-making in high-risk cardiac surgery. Hence, continuous measurement of lactate may be a valuable adjunct to routine hemodynamic parameters and blood gases, facilitating changes in fluid therapy and inotrope/vasopressor support for the achievement an adequate balance between oxygen demand and delivery. Combination of continuously measured lactate with monitoring of cardiac output, mixed and central venous saturation and Pv-aCO2 seems to be an attractive approach to "global view" on the systemic oxygen transport at the bedside. Recently, the continuous monitoring of lactate has been validated in a pilot clinical study in cardiosurgical patients mostly with isolated CABG and aortic valve replacement with relatively short-term CPB, however its' role in combined cardiac surgery with prolonged CPB, representing the important setting for lactate-guided therapy, remains unsettled.
Thus, the aim of our study is to assess the use of continuous monitoring of lactate in high-risk combined/complex cardiac surgery.
- Conditions
- Continuous Lactate Measurements, Cardiosurgery
- Being tested
- Eirus continuous lactate monitor
- Keywords
- Cardiosurgery, lactate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eirus continuous lactate monitorDevice
Also called Eirus (Maquet)
a triple-lumen central venous catheter (Eirus TLC) functioning as a regular central venous catheter (CVC) with an integrated microdialysis function will be inserted via the left jugular vein for continuous monitoring of lactate and glucose using Eirus intravascular microdialysis system (Maquet Critical Care, Solna, Sweden) after calibration with arterial sample. Eirus TLC will be used for both drug administration and blood sampling and will be removed postoperatively when a central line will no longer be necessary.
| Study group | Role | What they receive |
|---|---|---|
| Lactate monitoring | Experimental | The patients in the group will be subjected to the continuous perioperative monitoring of the venous blood lactate Receives: Device: Eirus continuous lactate monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperlactatemia
Presence of hyperlactatemia (> 2.0 mmol/l) in the intra- and postoperative period.
Measured: 0-24 hrs
Secondary outcomes (3)
Cardiac index
The incidence of low cardiac index (< 2,5 l/min/m2) The organ failure is to be diagnosed according to the well defined criteria
Measured: 0-24 hrs
Acute kidney injury
The incidence of acute kidney injury according to KDIGO criteria
Measured: 0-24 hrs
Respiratory distress
The incidence of acute respiratory distress syndrome (PaO2 / FiO2 < 300 mm Hg)
Measured: 0-24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous Lactate MeasurementsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikhail Y. Kirov, Northern State Medical University
- Investigators
- Mikhail Y. Kirov, MD, PhD, Principal investigator, Northern State Medical State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568969
- Sponsor's protocol ID
- LAC-1
- Acronym
- CLM-CARD
- Status last verified
- Mar 2016
- First submitted
- 30 Sep 2015
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Monitoring of Lactate in High-risk Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02568969
- Acronym / sponsor ID
- CLM-CARD / LAC-1
- Conditions
- Continuous Lactate Measurements, Cardiosurgery
- Keywords
- Cardiosurgery, lactate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Northern State Medical UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 6 Oct 2015 (estimated)
- 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.
The major combined interventions are between challenging and high-risk aspects of current cardiosurgical practice. The results of operation may be hampered by unexpected anatomic and technical features influencing the surgical approach as well as cardiopulmonary bypass (CPB), anesthesia, and respiratory support.
Plasma lactate concentration is a routine clinical indicator of the tissue oxygen shortage, and is routinely monitored in virtually all in-risk surgical and ICU patients. However, the discrete measurement of these values among with other biochemical values has a major drawback and continuous measurement can be beneficial.
The aim of our study is to assess the clinical usefulness and rationale for routine use of continuous monitoring of lactate in high-risk combined/complex cardiac surgery.
Detailed description
The combination of coronary artery bypass grafting (CABG), repair of valve pathology and/or valve replacement remains a challenging and high-risk aspect of current cardiosurgical practice. Direct and indirect results of surgery are affected by the variety of factors including patient's age, general condition, preoperative severity of heart dysfunction and remodeling, etc. In addition, the results of operation may be hampered by unexpected anatomic and technical features influencing the surgical approach as well as duration of cardiopulmonary bypass (CPB) and aortic cross clamping, anesthesia, intensive care and respiratory support.
The combined and complex cardiac surgery requires CPB, which, in parallel with increased duration of intervention, induces systemic inflammatory response and ischemia-reperfusion injury. These pathophysiological mechanisms include activation of cytokines, complement, neutrophils, monocytes, endothelium and platelets. Neutrophil sequestration in the vital organs in response to chemotaxis and release of reactive oxygen species and inflammatory mediators may result in tissue hypoperfusion and multiple organ dysfunction syndrome, contributing to development of postoperative complications and adverse outcomes.
To alleviate CPB-induced systemic inflammatory response and organ-specific injury, different interventions exist, including meticulous hemodynamic and metabolic monitoring followed by goal-directed therapy. Several recent studies from our group and other authors have clearly demonstrated the beneficial effects of such an approach in cardiac surgery. In these settings, when the extraction of O2 on cellular level may be severely disturbed, the complex analysis of changes in tissue perfusion and oxygenation before adjusting the therapy may be useful.
Current technique of continuous monitoring of lactate using Eirus system has a potential to broaden our knowledge in this clinical scenario and reinforce a decision-making in high-risk cardiac surgery. Hence, continuous measurement of lactate may be a valuable adjunct to routine hemodynamic parameters and blood gases, facilitating changes in fluid therapy and inotrope/vasopressor support for the achievement an adequate balance between oxygen demand and delivery. Combination of continuously measured lactate with monitoring of cardiac output, mixed and central venous saturation and Pv-aCO2 seems to be an attractive approach to "global view" on the systemic oxygen transport at the bedside. Recently, the continuous monitoring of lactate has been validated in a pilot clinical study in cardiosurgical patients mostly with isolated CABG and aortic valve replacement with relatively short-term CPB, however its' role in combined cardiac surgery with prolonged CPB, representing the important setting for lactate-guided therapy, remains unsettled.
Thus, the aim of our study is to assess the use of continuous monitoring of lactate in high-risk combined/complex cardiac surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lactate monitoring | Experimental | Device: Eirus continuous lactate monitorThe patients in the group will be subjected to the continuous perioperative monitoring of the venous blood lactate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent.
- Age above 18 years.
- Presence of coronary artery disease and/or valve regurgitation and/or stenosis
- Elective complex (two and more valves) and combined (valve + CABG) cardiac surgery requiring CPB with expected duration > 90 min.
Key exclusion criteria (2 listed)
- Participation in any other study.
- Morbid obesity (BWI > 40).
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 |
|---|---|---|
| Eirus continuous lactate monitorAlso: Eirus (Maquet)a triple-lumen central venous catheter (Eirus TLC) functioning as a regular central venous catheter (CVC) with an integrated microdialysis function will be inserted via the left jugular vein for continuous monitoring of lactate and glucose using Eirus intravascular microdialysis system (Maquet Critical Care, Solna, Sweden) after calibration with arterial sample. Eirus TLC will be used for both drug administration and blood sampling and will be removed postoperatively when a central line will no longer be necessary. | Device | Lactate monitoring |
Primary outcome
Hyperlactatemia
Time frame: 0-24 hrs
Presence of hyperlactatemia (> 2.0 mmol/l) in the intra- and postoperative period.
3 secondary outcomes
Cardiac index
Time frame: 0-24 hrs
Acute kidney injury
Time frame: 0-24 hrs
Respiratory distress
Time frame: 0-24 hrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
Related trials for Continuous Lactate Measurements
Active, not recruiting
A Single Centre Study Comparing Continuous Interstitial Fluid Lactate Detection to Standard Measurements of Lactate in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery and/or Valve Replacement.
Coronary Artery Bypass, Coronary Artery Bypass Graft
Active, not recruiting
A Single-centre Study Comparing a Non-invasive Lactate Sensor to Standard Invasive Measurements in Patients Undergoing Coronary Artery Bypass Surgery.
Cardiovascular, Coronary Artery Bypass
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.
Mikhail Y. Kirov, MD, PhD principal investigator
Northern State Medical State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eirus continuous lactate monitor in people with Continuous Lactate Measurements and Cardiosurgery, run by Northern State Medical University at 1 site in Russia.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyperlactatemia (time frame: 0-24 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2016.