Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery Requiring Extracorporeal CirculationMIT-CECNCT04125069
Role of Mitochondrial Dysfunction in the Occurrence of Acute Kidney Injury (AKI) in Postoperative Cardiac Surgery
An observational study of Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery Requiring Extracorporeal Circulation, run by University Hospital Center of Martinique at 1 site in France.
Trial summary
Cardiac Surgery and Acute Kidney Failure (AKI) post Surgery: AKI is a frequent complication in the immediate aftermath of cardiac surgery with an incidence varying from 5 to 40%. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery Requiring Extracorporeal Circulation
- What is being tested?
- Coronary Artery Bypass Graft (CABG)
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 2 Oct 2019to 2 Jan 2022
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing coronary artery bypass graft requiring circulation extracorporeal
Who may be able to join
- Be between 18 and 85 years old,
- Patients undergoing coronary artery bypass graft requiring circulation extracorporeal,
- Have been informed of the research,
- Having defended its decision of non-opposition to the research on samples taken during the treatment and on the data medical file,
- Patients affiliated to a social security scheme.
Who cannot join
- Pregnant or nursing woman,
- Diabetic type 1,
- Emergency cardiac surgery,
- Valvular replacement surgery,
- Clinical heart failure or ejection fraction of the ventricle left EFVG <50%,
- Valvular pathology,
Show all 12Show fewer
- Left atrial dilation> 40 mm,
- Systolic pulmonary arterial pressure> 40 mmHg,
- BNP (Brain natriuretic peptide) level> 100 ng / L,
- Atrial fibrillation or flutter,
- Right coronary stenosis> 50%,
- Chronic renal failure defined by a filtration rate Glomerular GFR (GFR) less than 60 ml / min / 1.73 m2 estimated from creatinine by the equation CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Mitochondrial Dysfunction in the Occurrence of Acute Kidney Injury(AKI) in Postoperative Cardiac Surgery
Cardiac Surgery and Acute Kidney Failure (AKI) post Surgery:
AKI is a frequent complication in the immediate aftermath of cardiac surgery with an incidence varying from 5 to 40%. KDIGO criteria (Kidney Disease: Improving Global Outcomes) are used to define the AKI in cardiac surgery because of their validated prognostic value in this patient population. The occurrence of a postoperative AKI, even of low severity, is accompanied by a significant increase in the duration of hospitalization and mortality. The AKI risk factors in cardiac surgery are related to the precarious clinical conditions of the patient before the surgery, to the complex surgical context, to the surgical procedures particularly the duration of extracorporeal circulation (ECC) greater than 120 min and the occurrence of a postoperative circulatory insufficiency.
Read more
AKI and inflammatory response:
The mechanisms involved in postoperative AKI in cardiac surgery, are low cardiac output, ischemia reperfusion injury (IRI), mechanical intravascular hemolysis, hypothermia, and activation of the neuroendocrine system by the ECC.
In addition, ECC triggers a secondary inflammatory response to blood contact with the ECC circuit and membranes. The secondary stimulation of immunocompetent cells accompanies secretion of many cytokines and proinflammatory mediators via the activation of nuclear transcription factors as the NFκB factor.
Of the 50 000 ECC performed per year in France, about 25% of the patients develop a Systemic Inflammatory Response Syndrome (SIRS). Although most often transient, SIRS can intensify and lead to a multi-visceral failure and to death, especially if the patient presents medical history of type 2 diabete. Increase of postoperative plasma cytokine levels has a positive predictive value on the occurrence of AKI and the risk of death.
Priming of the NLRP3 inflammasome and post ECC inflammatory response:
In addition to activation by nuclear transcription factors (NFκB), the inflammatory syndrome may develop secondarily to the activation of multi-protein platforms, called inflammasomes.
The activation of the NLRP3 inflammasome has been particularly studied in humans because of its association with multiple chronic inflammatory pathologies, infectious and cardio-metabolic diseases. Its activation is the combination of intracellular receptors like NOD-like receptors (NLR) types, ASC-like adapter proteins and pro caspase-1.
This assembly activates inflammatory caspases (caspase-1, in particular) responsible for the cleavage of pro-interleukins IL-1β and IL-18 in mature pro-inflammatory cytokines that participate in the orchestration of the inflammatory response.
Activation of the NLRP3 inflammasome requires prior priming which allows increase of NLRP3 and pro-cytokines IL1β and IL18 expressions. This priming is particularly intense in the presence of a mitochondrial dysfunction and of an increase in reactive oxygen species (ROS). Next, the activation of the NLRP3 inflammasome may be secondary to the presence of danger signals from cellular damages, such as cellular and mitochondrial debris (including mitochondrial DNA) recognized by NLRP3 receptors. Thus, preoperative mitochondrial dysfunction and its postoperative aggravation by ECC due to IRI induced by ECC represents powerful signals ,of the NLRP3 inflammasome activation.
Research hypothesis:
The hypothesis is that the preoperative priming of the NLRP3 inflammasome by a preoperative mitochondrial dysfunction is a factor favoring the occurrence of postoperative AKI after cardiac surgery with ECC.
For type 2 diabetic patients, the investigators think that preoperative mitochondrial dysfunction (mitochondrial respiration abnormalities and hyperpermeability of mitochondrial membranes) is accentuated worsening IRI induced by the ECC.
This increases postoperative release of cells and mitochondrial debris that maintain the activation of the NLRP3 inflammasome, exacerbating the inflammatory response and favoring the occurrence of AKI.
Read the detailed description
Primary objective of the research:
Describe the association between preoperatives mitochondrial dysfunction markers and the occurrence of AKI in postoperative cardiac surgery with ECC.
Secondary objective of research:
Describe, in preoperative cardiac surgery, the level of mitochondrial dysfunction according to type 2 diabetic status (inflammation-promoting factor).
- Conditions
- Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery Requiring Extracorporeal Circulation
- Being tested
- Coronary Artery Bypass Graft (CABG)
- Keywords
- Mitochondrial dysfunction, Acute Kidney Injury (AKI), Coronary Artery Bypass Graft (CABG) Surgery, Extracorporeal circulation, Inflammatory response, Type 2 diabete
- Medical subject headings
- Mitochondrial Diseases, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Artery Bypass Graft (CABG)Procedure or surgery
Mitochondrial function will be studied on cardiac tissue collected intraoperatively at the time of placement of the ECC cannulas by the surgeon. Fragments from auricle dissection of the right atrium of the patient will be requalified as sample residues, and will be used immediately by the surgeon to measure mitochondrial respiration (measurement of oxygen consumption by oxygenation and permeability test of the external mitochondrial membrane by the addition of cytochrome C in the oxygen chamber).
| Study group | Role | What they receive |
|---|---|---|
| Patients aged from 18 to 85 years | Cardiac surgery patients aged from 18 to 85 years,programmed for Coronary artery bypass graft requiring ECC. Receives: Procedure: Coronary Artery Bypass Graft (CABG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the correlation between preoperatives mitochondrial dysfunction markers and the occurrence of AKI in postoperative cardiac surgery with ECC.
Frequency of postoperative onset of an AKI defined according to KDIGO criteria according to preoperative mitochondrial dysfunction (preoperative levels of oxygen consumption by the mitochondria and permeability of the external mitochondrial membrane at Cytochrome CytC in heart tissue.
KDIGO criteria will be used for diagnosis of AKI, defined as an increase in plasma creatinine ≥0.3 mg/dl (≥26.5 μmol/l) in the 48hours (or an increase of more than 1.5 to 1.9 times the baseline) and urine output <0.5 ml/kg/h in the last 6 to 12 hours.
Measured: 15 months
Describe the correlation between preoperatives mitochondrial dysfunction markers and the occurrence of AKI in postoperative cardiac surgery with ECC.
To measure the mitochondrial respiration and to perform the permeability test of the mitochondrial external membrane, a high resolution oxygraph that can detect levels of mitochondrial respiration on few milligrams samples will be used (O2k, Oroboros, Innsbruck, Austria). Oxygen consumption fluxes will be expressed in pmol O2*s-1*mg-1 of dry tissue.
Measured: 15 months
Secondary outcomes (2)
Describe, in preoperative cardiac surgery, the level of mitochondrial dysfunction according to type 2 diabetic status (inflammation-promoting factor).
Diabetes will be diagnosed if the fasting blood glucose (8 hours) is equal to or greater than 1.26 g/l (7.0 mmol/l) twice or equal to or greater than 2 g/l at any time of the day.
A measurement of glycated hemoglobin (HbA1c) will help to know the glycemic balance of two to three months before the patient inclusion. Diabetes will be considered balanced if the HbA1c level is between 6 and 8%.
Measured: 15 months
Describe, in preoperative cardiac surgery, the level of mitochondrial dysfunction according to type 2 diabetic status (inflammation-promoting factor).
To measure the mitochondrial respiration and to perform the permeability test of the mitochondrial external membrane, a high resolution oxygraph that can detect levels of mitochondrial respiration on few milligrams samples will be used (O2k, Oroboros, Innsbruck, Austria). Oxygen consumption fluxes will be expressed in pmol O2*s-1*mg-1 of dry tissue.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start2 Oct 2019
- Primary completion12 Jul 2021
- Study completion2 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery Requiring Extracorporeal CirculationStudies 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rémi NEVIERE, PhD, Study director, CHU de Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125069
- Sponsor's protocol ID
- 18_RIPH3-24
- Acronym
- MIT-CEC
- Status last verified
- Feb 2022
- First submitted
- 9 Oct 2019
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zakkar M, Ascione R, James AF, Angelini GD, Suleiman MS. Inflammation, oxidative stress and postoperative atrial fibrillation in cardiac surgery. Pharmacol Ther. 2015 Oct;154:13-20. doi: 10.1016/j.pharmthera.2015.06.009. Epub 2015 Jun 24.
PubMed 26116810Corral-Velez V, Lopez-Delgado JC, Betancur-Zambrano NL, Lopez-Sune N, Rojas-Lora M, Torrado H, Ballus J. The inflammatory response in cardiac surgery: an overview of the pathophysiology and clinical implications. Inflamm Allergy Drug Targets. 2015;13(6):367-70. doi: 10.2174/1871528114666150529120801.
PubMed 26021321Hoste EAJ, Vandenberghe W. Epidemiology of cardiac surgery-associated acute kidney injury. Best Pract Res Clin Anaesthesiol. 2017 Sep;31(3):299-303. doi: 10.1016/j.bpa.2017.11.001. Epub 2017 Nov 8.
PubMed 29248137Wang Y, Bellomo R. Cardiac surgery-associated acute kidney injury: risk factors, pathophysiology and treatment. Nat Rev Nephrol. 2017 Nov;13(11):697-711. doi: 10.1038/nrneph.2017.119. Epub 2017 Sep 4.
PubMed 28869251Patel SS, Palant CE, Mahajan V, Chawla LS. Sequelae of AKI. Best Pract Res Clin Anaesthesiol. 2017 Sep;31(3):415-425. doi: 10.1016/j.bpa.2017.08.004. Epub 2017 Sep 6.
PubMed 29248147O'Neal JB, Shaw AD, Billings FT 4th. Acute kidney injury following cardiac surgery: current understanding and future directions. Crit Care. 2016 Jul 4;20(1):187. doi: 10.1186/s13054-016-1352-z.
PubMed 27373799Ortega-Loubon C, Fernandez-Molina M, Carrascal-Hinojal Y, Fulquet-Carreras E. Cardiac surgery-associated acute kidney injury. Ann Card Anaesth. 2016 Oct-Dec;19(4):687-698. doi: 10.4103/0971-9784.191578.
PubMed 27716701Rheinheimer J, de Souza BM, Cardoso NS, Bauer AC, Crispim D. Current role of the NLRP3 inflammasome on obesity and insulin resistance: A systematic review. Metabolism. 2017 Sep;74:1-9. doi: 10.1016/j.metabol.2017.06.002. Epub 2017 Jun 11.
PubMed 28764843Prochnicki T, Latz E. Inflammasomes on the Crossroads of Innate Immune Recognition and Metabolic Control. Cell Metab. 2017 Jul 5;26(1):71-93. doi: 10.1016/j.cmet.2017.06.018.
PubMed 28683296Feldman N, Rotter-Maskowitz A, Okun E. DAMPs as mediators of sterile inflammation in aging-related pathologies. Ageing Res Rev. 2015 Nov;24(Pt A):29-39. doi: 10.1016/j.arr.2015.01.003. Epub 2015 Jan 29.
PubMed 25641058Traba J, Sack MN. The role of caloric load and mitochondrial homeostasis in the regulation of the NLRP3 inflammasome. Cell Mol Life Sci. 2017 May;74(10):1777-1791. doi: 10.1007/s00018-016-2431-7. Epub 2016 Dec 10.
PubMed 27942750
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Mitochondrial Dysfunction in the Occurrence of Acute Kidney Injury(AKI) in Postoperative Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04125069
- Acronym / sponsor ID
- MIT-CEC / 18_RIPH3-24
- Conditions
- Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery Requiring Extracorporeal Circulation
- Keywords
- Mitochondrial dysfunction, Acute Kidney Injury (AKI), Coronary Artery Bypass Graft (CABG) Surgery, Extracorporeal circulation, Inflammatory response, Type 2 diabete
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 12 Jul 2021 (actual)
- Study completion
- 2 Jan 2022 (actual)
- First posted
- 14 Oct 2019 (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.
Cardiac Surgery and Acute Kidney Failure (AKI) post Surgery:
AKI is a frequent complication in the immediate aftermath of cardiac surgery with an incidence varying from 5 to 40%. KDIGO criteria (Kidney Disease: Improving Global Outcomes) are used to define the AKI in cardiac surgery because of their validated prognostic value in this patient population. The occurrence of a postoperative AKI, even of low severity, is accompanied by a significant increase in the duration of hospitalization and mortality. The AKI risk factors in cardiac surgery are related to the precarious clinical conditions of the patient before the surgery, to the complex surgical context, to the surgical procedures particularly the duration of extracorporeal circulation (ECC) greater than 120 min and the occurrence of a postoperative circulatory insufficiency.
AKI and inflammatory response:
The mechanisms involved in postoperative AKI in cardiac surgery, are low cardiac output, ischemia reperfusion injury (IRI), mechanical intravascular hemolysis, hypothermia, and activation of the neuroendocrine system by the ECC.
In addition, ECC triggers a secondary inflammatory response to blood contact with the ECC circuit and membranes. The secondary stimulation of immunocompetent cells accompanies secretion of many cytokines and proinflammatory mediators via the activation of nuclear transcription factors as the NFκB factor.
Of the 50 000 ECC performed per year in France, about 25% of the patients develop a Systemic Inflammatory Response Syndrome (SIRS). Although most often transient, SIRS can intensify and lead to a multi-visceral failure and to death, especially if the patient presents medical history of type 2 diabete. Increase of postoperative plasma cytokine levels has a positive predictive value on the occurrence of AKI and the risk of death.
Priming of the NLRP3 inflammasome and post ECC inflammatory response:
In addition to activation by nuclear transcription factors (NFκB), the inflammatory syndrome may develop secondarily to the activation of multi-protein platforms, called inflammasomes.
The activation of the NLRP3 inflammasome has been particularly studied in humans because of its association with multiple chronic inflammatory pathologies, infectious and cardio-metabolic diseases. Its activation is the combination of intracellular receptors like NOD-like receptors (NLR) types, ASC-like adapter proteins and pro caspase-1.
This assembly activates inflammatory caspases (caspase-1, in particular) responsible for the cleavage of pro-interleukins IL-1β and IL-18 in mature pro-inflammatory cytokines that participate in the orchestration of the inflammatory response.
Activation of the NLRP3 inflammasome requires prior priming which allows increase of NLRP3 and pro-cytokines IL1β and IL18 expressions. This priming is particularly intense in the presence of a mitochondrial dysfunction and of an increase in reactive oxygen species (ROS). Next, the activation of the NLRP3 inflammasome may be secondary to the presence of danger signals from cellular damages, such as cellular and mitochondrial debris (including mitochondrial DNA) recognized by NLRP3 receptors. Thus, preoperative mitochondrial dysfunction and its postoperative aggravation by ECC due to IRI induced by ECC represents powerful signals ,of the NLRP3 inflammasome activation.
Research hypothesis:
The hypothesis is that the preoperative priming of the NLRP3 inflammasome by a preoperative mitochondrial dysfunction is a factor favoring the occurrence of postoperative AKI after cardiac surgery with ECC.
For type 2 diabetic patients, the investigators think that preoperative mitochondrial dysfunction (mitochondrial respiration abnormalities and hyperpermeability of mitochondrial membranes) is accentuated worsening IRI induced by the ECC.
This increases postoperative release of cells and mitochondrial debris that maintain the activation of the NLRP3 inflammasome, exacerbating the inflammatory response and favoring the occurrence of AKI.
Detailed description
Primary objective of the research:
Describe the association between preoperatives mitochondrial dysfunction markers and the occurrence of AKI in postoperative cardiac surgery with ECC.
Secondary objective of research:
Describe, in preoperative cardiac surgery, the level of mitochondrial dysfunction according to type 2 diabetic status (inflammation-promoting factor).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients aged from 18 to 85 years | – | Procedure: Coronary Artery Bypass Graft (CABG)Cardiac surgery patients aged from 18 to 85 years,programmed for Coronary artery bypass graft requiring ECC. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing coronary artery bypass graft requiring circulation extracorporeal
Key inclusion criteria (5 listed)
- Be between 18 and 85 years old,
- Patients undergoing coronary artery bypass graft requiring circulation extracorporeal,
- Have been informed of the research,
- Having defended its decision of non-opposition to the research on samples taken during the treatment and on the data medical file,
- Patients affiliated to a social security scheme.
Key exclusion criteria (12 listed)
- Pregnant or nursing woman,
- Diabetic type 1,
- Emergency cardiac surgery,
- Valvular replacement surgery,
- Clinical heart failure or ejection fraction of the ventricle left EFVG <50%,
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 |
|---|---|---|
| Coronary Artery Bypass Graft (CABG)Mitochondrial function will be studied on cardiac tissue collected intraoperatively at the time of placement of the ECC cannulas by the surgeon. Fragments from auricle dissection of the right atrium of the patient will be requalified as sample residues, and will be used immediately by the surgeon to measure mitochondrial respiration (measurement of oxygen consumption by oxygenation and permeability test of the external mitochondrial membrane by the addition of cytochrome C in the oxygen chamber). | Procedure or surgery | Patients aged from 18 to 85 years |
Primary outcome
Describe the correlation between preoperatives mitochondrial dysfunction markers and the occurrence of AKI in postoperative cardiac surgery with ECC.
Time frame: 15 months
Frequency of postoperative onset of an AKI defined according to KDIGO criteria according to preoperative mitochondrial dysfunction (preoperative levels of oxygen consumption by the mitochondria and permeability of the external mitochondrial membrane at Cytochrome CytC in heart tissue. KDIGO criteria will be used for diagnosis of AKI, defined as an increase in plasma creatinine ≥0.3 mg/dl (≥26.5 μmol/l) in the 48hours (or an increase of more than 1.5 to 1.9 times the baseline) and urine output <0.5 ml/kg/h in the last 6 to 12 hours.
Describe the correlation between preoperatives mitochondrial dysfunction markers and the occurrence of AKI in postoperative cardiac surgery with ECC.
Time frame: 15 months
To measure the mitochondrial respiration and to perform the permeability test of the mitochondrial external membrane, a high resolution oxygraph that can detect levels of mitochondrial respiration on few milligrams samples will be used (O2k, Oroboros, Innsbruck, Austria). Oxygen consumption fluxes will be expressed in pmol O2*s-1*mg-1 of dry tissue.
2 secondary outcomes
Describe, in preoperative cardiac surgery, the level of mitochondrial dysfunction according to type 2 diabetic status (inflammation-promoting factor).
Time frame: 15 months
Describe, in preoperative cardiac surgery, the level of mitochondrial dysfunction according to type 2 diabetic status (inflammation-promoting factor).
Time frame: 15 months
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 Feb 2022.
- Background: PubMed 26116810Zakkar M, Ascione R, James AF, Angelini GD, Suleiman MS. Inflammation, oxidative stress and postoperative atrial fibrillation in cardiac surgery. Pharmacol Ther. 2015 Oct;154:13-20. doi: 10.1016/j.pharmthera.2015.06.009. Epub 2015 Jun 24.
- Background: PubMed 26021321Corral-Velez V, Lopez-Delgado JC, Betancur-Zambrano NL, Lopez-Sune N, Rojas-Lora M, Torrado H, Ballus J. The inflammatory response in cardiac surgery: an overview of the pathophysiology and clinical implications. Inflamm Allergy Drug Targets. 2015;13(6):367-70. doi: 10.2174/1871528114666150529120801.
- Background: PubMed 29248137Hoste EAJ, Vandenberghe W. Epidemiology of cardiac surgery-associated acute kidney injury. Best Pract Res Clin Anaesthesiol. 2017 Sep;31(3):299-303. doi: 10.1016/j.bpa.2017.11.001. Epub 2017 Nov 8.
- Background: PubMed 28869251Wang Y, Bellomo R. Cardiac surgery-associated acute kidney injury: risk factors, pathophysiology and treatment. Nat Rev Nephrol. 2017 Nov;13(11):697-711. doi: 10.1038/nrneph.2017.119. Epub 2017 Sep 4.
- Background: PubMed 29248147Patel SS, Palant CE, Mahajan V, Chawla LS. Sequelae of AKI. Best Pract Res Clin Anaesthesiol. 2017 Sep;31(3):415-425. doi: 10.1016/j.bpa.2017.08.004. Epub 2017 Sep 6.
- Background: PubMed 27373799O'Neal JB, Shaw AD, Billings FT 4th. Acute kidney injury following cardiac surgery: current understanding and future directions. Crit Care. 2016 Jul 4;20(1):187. doi: 10.1186/s13054-016-1352-z.
- Background: PubMed 27716701Ortega-Loubon C, Fernandez-Molina M, Carrascal-Hinojal Y, Fulquet-Carreras E. Cardiac surgery-associated acute kidney injury. Ann Card Anaesth. 2016 Oct-Dec;19(4):687-698. doi: 10.4103/0971-9784.191578.
- Background: PubMed 28764843Rheinheimer J, de Souza BM, Cardoso NS, Bauer AC, Crispim D. Current role of the NLRP3 inflammasome on obesity and insulin resistance: A systematic review. Metabolism. 2017 Sep;74:1-9. doi: 10.1016/j.metabol.2017.06.002. Epub 2017 Jun 11.
- Background: PubMed 28683296Prochnicki T, Latz E. Inflammasomes on the Crossroads of Innate Immune Recognition and Metabolic Control. Cell Metab. 2017 Jul 5;26(1):71-93. doi: 10.1016/j.cmet.2017.06.018.
- Background: PubMed 25641058Feldman N, Rotter-Maskowitz A, Okun E. DAMPs as mediators of sterile inflammation in aging-related pathologies. Ageing Res Rev. 2015 Nov;24(Pt A):29-39. doi: 10.1016/j.arr.2015.01.003. Epub 2015 Jan 29.
- Background: PubMed 27942750Traba J, Sack MN. The role of caloric load and mitochondrial homeostasis in the regulation of the NLRP3 inflammasome. Cell Mol Life Sci. 2017 May;74(10):1777-1791. doi: 10.1007/s00018-016-2431-7. Epub 2016 Dec 10.
- Individual participant dataSharing planned: No
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.
Rémi NEVIERE, PhD study director
CHU de Martinique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery Requiring Extracorporeal Circulation, run by University Hospital Center of Martinique at 1 site in France.
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 5 inclusion and 12 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 Feb 2022. 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 France. 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?
Describe the correlation between preoperatives mitochondrial dysfunction markers and the occurrence of AKI in postoperative cardiac surgery with ECC. (time frame: 15 months). The study lists 2 primary outcomes in all. 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 NCT04125069, which also lists 11 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 24 Feb 2022.