SarcopeniaNCT03644030
Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
An observational study of Sarcopenia and Post-operative Infections, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
In general, malnutrition in surgical patients is associated with a higher risk of postoperative infections, decreased immune response, more cardiac complications, prolonged mechanical ventilation , and a higher rate of reimportation due to several other complications than lead to an increase in morbidity and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia, Post-operative Infections, Sepsis
- How many people
- 179 participants
- Where
- 1 siteGreece
- Study dates
- 6 Sep 2018to 1 Sep 2019
- 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 scheduled to undergo cardiac surgery for coronary revascularization or valvular heart disease
Who may be able to join
- age >18 years
- planned introduction for cardiac operation with CPB[cardiopulmonary bypass]
- coronary artery bypass surgery
- heart valve surgery [heart valve surgery]
Who cannot join
- non-consent of the patient
- urgent admissions - operations
- pacemaker exist
- congenital heart disease
- recent [<3-month] open-heart surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Assessment of Phase Angle, Lean Body Mass Index and Tissue Edema to Assess the Nutritional Status and Immediate Outcome of Cardiac Surgery Patients:an Open, Prospective Study of Observation / Recording
In general, malnutrition in surgical patients is associated with a higher risk of postoperative infections, decreased immune response, more cardiac complications, prolonged mechanical ventilation , and a higher rate of reimportation due to several other complications than lead to an increase in morbidity and mortality, a prolongation of the total hospitalization time in the ICU[intensive care unit ] and the chamber, and a delay in the healing of the surgical trauma .
The presence of a low percentage of lean mass, as calculated by the technique of bioelectric conductivity, practically means a small percentage of muscle tissue. However, muscle tissue is an important, if not the only source of amino acids for both protein synthesis and gluconeogenesis in stress conditions, such as surgery and the first postoperative days. Thus, post-operative patients in general, and cardio-operated patients, in particular, having a low lean mass have minimal reserves to the stress requirements, resulting in an increased risk of complications.
Read more
In the last few years, the most reliable indicator of malnutrition- in addition to the lean mass index - began to be considered the phase angle, which is also calculated when measuring the bioreduction of electrical conductivity, although there is a very recent challenge . The phase angle expresses the relationship between the electrical reactance, i.e. the state of the cell membrane, to resist the permeability and the resistance, i.e. the restriction to the flow of the electrical current through the body, mainly related to the water of the tissues . Like the FFM[fat-free mass]- index, the phase angle uses the total water of the tissues, and thus also reflects the cell mass. In addition, however, it also measures the resistance of cell membranes, so it also evaluates their quality and is therefore considered to be a reliable indicator of poor nutritional status , although some also maintain demur due to the possible poor distribution of extracellular fluid in cardiological patients.
From all of the above, it appears that there are some gaps in the evaluation of the patients who are going to undergo cardiac surgery regarding their nutritional status, both because the classic nutrition control indicators are not fully documented as being reliable for these patients, and there are no studies to monitor and compare body composition directly to any other index postoperatively.
Read the detailed description
The study protocol-mandated baseline data will include demographics, comorbidities, EuroSCORE[European System for Cardiac Operative Risk Evaluation] II, C-reactive protein, left ventricular ejection fraction (by transthoracic echocardiography) and peak expiratory flow rate (assessed by spirometry). Physical performance status will be assessed by APACHE [Acute Physiology And Chronic Health Evaluation] II score. Furthermore, SOFA [Sequential [Sepsis-related] Organ Failure Assessment] score will be assessed preoperatively and up to 7th postoperative day.
Preoperatively and on the 7th postoperative day, the following parameters will be calculated or measured and then recorded:
- Anthropometric data including body height, weight and waist circumference measurement, estimation of waist/circumference ratio and calculation of body mass index [BMI].
- Nutritional status will be assessed by MUST[Malnutrition Universal Screening Tool] score
- Body composition analysis using bioelectrical impedance analysis [BIA], will be performed for the calculation of FFM [fat-free mass] and fat mass [FM] indicators, intracellular, extracellular and total water [ICW, ECW, TBW] and phase angle parameter [PhA]. Additionally, muscular power will be assessed by handgrip strength [HGS], the upper third triangle perimeter and skin fold thickness will be measured.
- Daily calorie and protein needs of each patient will be calculated
During hospitalization, the following parameters will be recorded:
- Type of diet [parenteral, intestinal, oral]
- Post-operative infections involving respiratory system, medieval space, sternum trauma, lower limb trauma (if present) and endocarditis.
- The occurrence of organ dysfunction or sepsis. Sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. For clinical operationalization, organ dysfunction will be represented by an increase in the Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score of 2 points or more, which will be associated with an in-hospital mortality greater than 10%.
- Thromboembolic events such as stroke, peripheral venous thrombosis and pulmonary embolism.
- Acute renal failure.
- Re-operation for bleeding.
- Need for inotropic or vasoactive support.
- Hospitalization data (intubation> 24 hours, duration of mechanical ventilation and ICU stay, duration of hospital stay, in-hospital mortality
- Conditions
- Sarcopenia, Post-operative Infections, Sepsis
- Keywords
- FFM index, tissue edema index [extracellular / total water - ECW / TBW], phase angle
- Medical subject headings
- Sarcopenia, Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase angle in patients undergoing cardiac surgery as indicator of their nutrition status.
Phase angle [PhA(°) = (reactance/electrical resistance) × (180°/Π)] will be measured in degrees using bioelectrical impedance analysis and check whether it can be considered as a reliable indicator of the nutrition status of cardiac surgery patients undergoing cardiac surgery during the preoperative and postoperative periods. PhA will be calculated by using the sum of impedance and reactance of the right arm, trunk, and right leg and based on the following equation, PhA(°) = (Reactance/Resistance) × (180°/Π). Π is the mathematical value of 3.1415 and This conversion is performed to convert the final value from radians into degrees.The normal range of phase angle is 5.84 ± 0.75.The primary change is the reduction of the mean phase angle postoperative by 1.0 unit (standard deviation ± 2.0) and this leads to increased morbidity, mortality.
Measured: 7 days post operation
Secondary outcomes (2)
FFM[fat-free mass] index(kilograms/(meter x meter)- kg/m-2) in patients undergoing cardiac surgery as indicator of their nutrition status
measure of FFM [fat-free mass] index( kgm-2) using bioelectrical impedance analysis and check if it can be a reliable indicator of the nutrition status of patients undergoing cardiac surgery during the preoperative and post-operative periods and how this leads to increased morbidity, mortality.
Measured: 7 days post operation
Tissue edema index [extracellular(Litre) / total water(Litre) - ECW / TBW] in patients undergoing cardiac surgery as indicator of their nutrition status.
measure of the tissue edema index [extracellular(Litre) / total water(Litre) - ECW / TBW] using bioelectrical impedance analysis and check if it can be a reliable indicator of the nutrition status of patients undergoing cardiac surgery during the preoperative and post-operative periods and if this associated with postoperative complications.
Measured: 7 days post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start6 Sep 2018
- Primary completion15 Aug 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, katerina kotzampassi, Aristotle University Of Thessaloniki
- Investigators
- Katerina Kotzampassi, Study director, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644030
- Sponsor's protocol ID
- CardioMass
- Status last verified
- Sep 2018
- First submitted
- 11 Aug 2018
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Visser M, van Venrooij LM, Vulperhorst L, de Vos R, Wisselink W, van Leeuwen PA, de Mol BA. Sarcopenic obesity is associated with adverse clinical outcome after cardiac surgery. Nutr Metab Cardiovasc Dis. 2013 Jun;23(6):511-8. doi: 10.1016/j.numecd.2011.12.001. Epub 2012 Mar 6.
PubMed 22397879Lomivorotov VV, Efremov SM, Boboshko VA, Nikolaev DA, Vedernikov PE, Deryagin MN, Lomivorotov VN, Karaskov AM. Prognostic value of nutritional screening tools for patients scheduled for cardiac surgery. Interact Cardiovasc Thorac Surg. 2013 May;16(5):612-8. doi: 10.1093/icvts/ivs549. Epub 2013 Jan 29.
PubMed 23360716Gomez-Perez SL, Haus JM, Sheean P, Patel B, Mar W, Chaudhry V, McKeever L, Braunschweig C. Measuring Abdominal Circumference and Skeletal Muscle From a Single Cross-Sectional Computed Tomography Image: A Step-by-Step Guide for Clinicians Using National Institutes of Health ImageJ. JPEN J Parenter Enteral Nutr. 2016 Mar;40(3):308-18. doi: 10.1177/0148607115604149. Epub 2015 Sep 21.
PubMed 26392166Tsaousi G, Panidis S, Stavrou G, Tsouskas J, Panagiotou D, Kotzampassi K. Prognostic indices of poor nutritional status and their impact on prolonged hospital stay in a Greek university hospital. Biomed Res Int. 2014;2014:924270. doi: 10.1155/2014/924270. Epub 2014 Mar 23.
PubMed 24779021van Venrooij LM, de Vos R, Borgmeijer-Hoelen MM, Haaring C, de Mol BA. Preoperative unintended weight loss and low body mass index in relation to complications and length of stay after cardiac surgery. Am J Clin Nutr. 2008 Jun;87(6):1656-61. doi: 10.1093/ajcn/87.6.1656.
PubMed 18541553van Venrooij LM, de Vos R, Zijlstra E, Borgmeijer-Hoelen MM, van Leeuwen PA, de Mol BA. The impact of low preoperative fat-free body mass on infections and length of stay after cardiac surgery: a prospective cohort study. J Thorac Cardiovasc Surg. 2011 Nov;142(5):1263-9. doi: 10.1016/j.jtcvs.2011.07.033. Epub 2011 Aug 19.
PubMed 21855896Visser M, van Venrooij LM, Wanders DC, de Vos R, Wisselink W, van Leeuwen PA, de Mol BA. The bioelectrical impedance phase angle as an indicator of undernutrition and adverse clinical outcome in cardiac surgical patients. Clin Nutr. 2012 Dec;31(6):981-6. doi: 10.1016/j.clnu.2012.05.002. Epub 2012 May 27.
PubMed 22640476Tsaousi G, Kokkota S, Papakostas P, Stavrou G, Doumaki E, Kotzampassi K. Body composition analysis for discrimination of prolonged hospital stay in colorectal cancer surgery patients. Eur J Cancer Care (Engl). 2017 Nov;26(6). doi: 10.1111/ecc.12491. Epub 2016 Mar 16.
PubMed 26990464Engelman DT, Adams DH, Byrne JG, Aranki SF, Collins JJ Jr, Couper GS, Allred EN, Cohn LH, Rizzo RJ. Impact of body mass index and albumin on morbidity and mortality after cardiac surgery. J Thorac Cardiovasc Surg. 1999 Nov;118(5):866-73. doi: 10.1016/s0022-5223(99)70056-5.
PubMed 10534692van Straten AH, Bramer S, Soliman Hamad MA, van Zundert AA, Martens EJ, Schonberger JP, de Wolf AM. Effect of body mass index on early and late mortality after coronary artery bypass grafting. Ann Thorac Surg. 2010 Jan;89(1):30-7. doi: 10.1016/j.athoracsur.2009.09.050.
PubMed 20103201Wagner BD, Grunwald GK, Rumsfeld JS, Hill JO, Ho PM, Wyatt HR, Shroyer AL. Relationship of body mass index with outcomes after coronary artery bypass graft surgery. Ann Thorac Surg. 2007 Jul;84(1):10-6. doi: 10.1016/j.athoracsur.2007.03.017.
PubMed 17588373Soeters PB, Schols AM. Advances in understanding and assessing malnutrition. Curr Opin Clin Nutr Metab Care. 2009 Sep;12(5):487-94. doi: 10.1097/MCO.0b013e32832da243.
PubMed 19512916
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Assessment of Phase Angle, Lean Body Mass Index and Tissue Edema to Assess the Nutritional Status and Immediate Outcome of Cardiac Surgery Patients:an Open, Prospective Study of Observation / Recording
- ClinicalTrials.gov ID
- NCT03644030
- Acronym / sponsor ID
- CardioMass
- Conditions
- Sarcopenia, Post-operative Infections, Sepsis
- Keywords
- FFM index, tissue edema index [extracellular / total water - ECW / TBW], phase angle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 6 Sep 2018 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 23 Aug 2018 (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.
In general, malnutrition in surgical patients is associated with a higher risk of postoperative infections, decreased immune response, more cardiac complications, prolonged mechanical ventilation , and a higher rate of reimportation due to several other complications than lead to an increase in morbidity and mortality, a prolongation of the total hospitalization time in the ICU[intensive care unit ] and the chamber, and a delay in the healing of the surgical trauma .
The presence of a low percentage of lean mass, as calculated by the technique of bioelectric conductivity, practically means a small percentage of muscle tissue. However, muscle tissue is an important, if not the only source of amino acids for both protein synthesis and gluconeogenesis in stress conditions, such as surgery and the first postoperative days. Thus, post-operative patients in general, and cardio-operated patients, in particular, having a low lean mass have minimal reserves to the stress requirements, resulting in an increased risk of complications.
In the last few years, the most reliable indicator of malnutrition- in addition to the lean mass index - began to be considered the phase angle, which is also calculated when measuring the bioreduction of electrical conductivity, although there is a very recent challenge . The phase angle expresses the relationship between the electrical reactance, i.e. the state of the cell membrane, to resist the permeability and the resistance, i.e. the restriction to the flow of the electrical current through the body, mainly related to the water of the tissues . Like the FFM[fat-free mass]- index, the phase angle uses the total water of the tissues, and thus also reflects the cell mass. In addition, however, it also measures the resistance of cell membranes, so it also evaluates their quality and is therefore considered to be a reliable indicator of poor nutritional status , although some also maintain demur due to the possible poor distribution of extracellular fluid in cardiological patients.
From all of the above, it appears that there are some gaps in the evaluation of the patients who are going to undergo cardiac surgery regarding their nutritional status, both because the classic nutrition control indicators are not fully documented as being reliable for these patients, and there are no studies to monitor and compare body composition directly to any other index postoperatively.
Detailed description
The study protocol-mandated baseline data will include demographics, comorbidities, EuroSCORE[European System for Cardiac Operative Risk Evaluation] II, C-reactive protein, left ventricular ejection fraction (by transthoracic echocardiography) and peak expiratory flow rate (assessed by spirometry). Physical performance status will be assessed by APACHE [Acute Physiology And Chronic Health Evaluation] II score. Furthermore, SOFA [Sequential [Sepsis-related] Organ Failure Assessment] score will be assessed preoperatively and up to 7th postoperative day.
Preoperatively and on the 7th postoperative day, the following parameters will be calculated or measured and then recorded:
- Anthropometric data including body height, weight and waist circumference measurement, estimation of waist/circumference ratio and calculation of body mass index [BMI].
- Nutritional status will be assessed by MUST[Malnutrition Universal Screening Tool] score
- Body composition analysis using bioelectrical impedance analysis [BIA], will be performed for the calculation of FFM [fat-free mass] and fat mass [FM] indicators, intracellular, extracellular and total water [ICW, ECW, TBW] and phase angle parameter [PhA]. Additionally, muscular power will be assessed by handgrip strength [HGS], the upper third triangle perimeter and skin fold thickness will be measured.
- Daily calorie and protein needs of each patient will be calculated
During hospitalization, the following parameters will be recorded:
- Type of diet [parenteral, intestinal, oral]
- Post-operative infections involving respiratory system, medieval space, sternum trauma, lower limb trauma (if present) and endocarditis.
- The occurrence of organ dysfunction or sepsis. Sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. For clinical operationalization, organ dysfunction will be represented by an increase in the Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score of 2 points or more, which will be associated with an in-hospital mortality greater than 10%.
- Thromboembolic events such as stroke, peripheral venous thrombosis and pulmonary embolism.
- Acute renal failure.
- Re-operation for bleeding.
- Need for inotropic or vasoactive support.
- Hospitalization data (intubation> 24 hours, duration of mechanical ventilation and ICU stay, duration of hospital stay, in-hospital mortality
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to undergo cardiac surgery for coronary revascularization or valvular heart disease
Key inclusion criteria (4 listed)
- age >18 years
- planned introduction for cardiac operation with CPB[cardiopulmonary bypass]
- coronary artery bypass surgery
- heart valve surgery [heart valve surgery]
Key exclusion criteria (5 listed)
- non-consent of the patient
- urgent admissions - operations
- pacemaker exist
- congenital heart disease
- recent [<3-month] open-heart surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Phase angle in patients undergoing cardiac surgery as indicator of their nutrition status.
Time frame: 7 days post operation
Phase angle [PhA(°) = (reactance/electrical resistance) × (180°/Π)] will be measured in degrees using bioelectrical impedance analysis and check whether it can be considered as a reliable indicator of the nutrition status of cardiac surgery patients undergoing cardiac surgery during the preoperative and postoperative periods. PhA will be calculated by using the sum of impedance and reactance of the right arm, trunk, and right leg and based on the following equation, PhA(°) = (Reactance/Resistance) × (180°/Π). Π is the mathematical value of 3.1415 and This conversion is performed to convert the final value from radians into degrees.The normal range of phase angle is 5.84 ± 0.75.The primary change is the reduction of the mean phase angle postoperative by 1.0 unit (standard deviation ± 2.0) and this leads to increased morbidity, mortality.
2 secondary outcomes
FFM[fat-free mass] index(kilograms/(meter x meter)- kg/m-2) in patients undergoing cardiac surgery as indicator of their nutrition status
Time frame: 7 days post operation
Tissue edema index [extracellular(Litre) / total water(Litre) - ECW / TBW] in patients undergoing cardiac surgery as indicator of their nutrition status.
Time frame: 7 days post operation
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 9 Sep 2019.
- Background: PubMed 22397879Visser M, van Venrooij LM, Vulperhorst L, de Vos R, Wisselink W, van Leeuwen PA, de Mol BA. Sarcopenic obesity is associated with adverse clinical outcome after cardiac surgery. Nutr Metab Cardiovasc Dis. 2013 Jun;23(6):511-8. doi: 10.1016/j.numecd.2011.12.001. Epub 2012 Mar 6.
- Background: PubMed 23360716Lomivorotov VV, Efremov SM, Boboshko VA, Nikolaev DA, Vedernikov PE, Deryagin MN, Lomivorotov VN, Karaskov AM. Prognostic value of nutritional screening tools for patients scheduled for cardiac surgery. Interact Cardiovasc Thorac Surg. 2013 May;16(5):612-8. doi: 10.1093/icvts/ivs549. Epub 2013 Jan 29.
- Background: PubMed 26392166Gomez-Perez SL, Haus JM, Sheean P, Patel B, Mar W, Chaudhry V, McKeever L, Braunschweig C. Measuring Abdominal Circumference and Skeletal Muscle From a Single Cross-Sectional Computed Tomography Image: A Step-by-Step Guide for Clinicians Using National Institutes of Health ImageJ. JPEN J Parenter Enteral Nutr. 2016 Mar;40(3):308-18. doi: 10.1177/0148607115604149. Epub 2015 Sep 21.
- Background: PubMed 24779021Tsaousi G, Panidis S, Stavrou G, Tsouskas J, Panagiotou D, Kotzampassi K. Prognostic indices of poor nutritional status and their impact on prolonged hospital stay in a Greek university hospital. Biomed Res Int. 2014;2014:924270. doi: 10.1155/2014/924270. Epub 2014 Mar 23.
- Background: PubMed 18541553van Venrooij LM, de Vos R, Borgmeijer-Hoelen MM, Haaring C, de Mol BA. Preoperative unintended weight loss and low body mass index in relation to complications and length of stay after cardiac surgery. Am J Clin Nutr. 2008 Jun;87(6):1656-61. doi: 10.1093/ajcn/87.6.1656.
- Background: PubMed 21855896van Venrooij LM, de Vos R, Zijlstra E, Borgmeijer-Hoelen MM, van Leeuwen PA, de Mol BA. The impact of low preoperative fat-free body mass on infections and length of stay after cardiac surgery: a prospective cohort study. J Thorac Cardiovasc Surg. 2011 Nov;142(5):1263-9. doi: 10.1016/j.jtcvs.2011.07.033. Epub 2011 Aug 19.
- Background: PubMed 22640476Visser M, van Venrooij LM, Wanders DC, de Vos R, Wisselink W, van Leeuwen PA, de Mol BA. The bioelectrical impedance phase angle as an indicator of undernutrition and adverse clinical outcome in cardiac surgical patients. Clin Nutr. 2012 Dec;31(6):981-6. doi: 10.1016/j.clnu.2012.05.002. Epub 2012 May 27.
- Background: PubMed 26990464Tsaousi G, Kokkota S, Papakostas P, Stavrou G, Doumaki E, Kotzampassi K. Body composition analysis for discrimination of prolonged hospital stay in colorectal cancer surgery patients. Eur J Cancer Care (Engl). 2017 Nov;26(6). doi: 10.1111/ecc.12491. Epub 2016 Mar 16.
- Background: PubMed 10534692Engelman DT, Adams DH, Byrne JG, Aranki SF, Collins JJ Jr, Couper GS, Allred EN, Cohn LH, Rizzo RJ. Impact of body mass index and albumin on morbidity and mortality after cardiac surgery. J Thorac Cardiovasc Surg. 1999 Nov;118(5):866-73. doi: 10.1016/s0022-5223(99)70056-5.
- Background: PubMed 20103201van Straten AH, Bramer S, Soliman Hamad MA, van Zundert AA, Martens EJ, Schonberger JP, de Wolf AM. Effect of body mass index on early and late mortality after coronary artery bypass grafting. Ann Thorac Surg. 2010 Jan;89(1):30-7. doi: 10.1016/j.athoracsur.2009.09.050.
- Background: PubMed 17588373Wagner BD, Grunwald GK, Rumsfeld JS, Hill JO, Ho PM, Wyatt HR, Shroyer AL. Relationship of body mass index with outcomes after coronary artery bypass graft surgery. Ann Thorac Surg. 2007 Jul;84(1):10-6. doi: 10.1016/j.athoracsur.2007.03.017.
- Background: PubMed 19512916Soeters PB, Schols AM. Advances in understanding and assessing malnutrition. Curr Opin Clin Nutr Metab Care. 2009 Sep;12(5):487-94. doi: 10.1097/MCO.0b013e32832da243.
- Individual participant dataSharing planned: No
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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.
Katerina Kotzampassi study director
Aristotle University Of Thessaloniki
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 Sarcopenia and Post-operative Infections, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 5 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 9 Sep 2019. 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 Greece. 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?
Phase angle in patients undergoing cardiac surgery as indicator of their nutrition status. (time frame: 7 days post operation). 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 NCT03644030, which also lists 12 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 9 Sep 2019.