Cardiac SurgeryNCT05341037
Red Cell Distribution With to Lymphocyte Ratio in Cardiac Surgery
An observational study of Cardiac Surgery, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
It is aimed to investigate whether red cell distribution with (RDW) to lymphocyte ratio (RLR) can predict early comorbidity among cardiac surgery patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- How many people
- 700 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2022to 1 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have undergone open-heart surgery with cardiopulmonary bypass in our hospital within the last year will be evaluated retrospectively.
Who may be able to join
- Adult patients undergoing open-heart surgery with cardiopulmonary bypass
Who cannot join
- Re-operations
- Emergency operations
- Patients with preoperative renal failure
- Patients with preoperative hematological problems
- Patients with preoperative infection
- Patients with preoperative immunological disease
- Patients using preoperative steroids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Biomarker for the Prediction of Early Comorbidity in Cardiac Surgery: Red Cell Distribution With to Lymphocyte Ratio
It is aimed to investigate whether red cell distribution with (RDW) to lymphocyte ratio (RLR) can predict early comorbidity among cardiac surgery patients.
Read the detailed description
There are important developments in the field of cardiac surgery due to advances in medical treatments, surgical techniques, intraoperative anesthesia management, and postoperative intensive care. On the other hand, the proportion of high-risk patients has increased due to the increasing number of elderly patients with comorbidities presenting for cardiac surgery. It is important to analyze outcomes such as postoperative morbidity and mortality, due to concerns about the quality of life of patients after cardiac operations, the recommendations of current ERAS protocols, and the shortening of intensive care unit length of stay. Complications such as cardiac, pulmonary, renal, and neurological disorders, infections such as pneumonia or sepsis, and prolonged stay in the intensive care unit and hospital are indicators of not only the quality of care but also the quality of life after cardiac surgery. Therefore, it is important to determine the perioperative risk factors that cause postoperative morbidity. Various outcome prediction models are used for cardiac surgery, such as the Cardiac Anesthesia Risk Assessment score, Tuman score, Tu score, and the European System for Cardiac Operative Risk Assessment score, which uses preoperative factors to predict the postoperative outcomes. It is known that intraoperative factors such as CPB duration, aortic cross-clamp time, surgical technique, and serum lactate levels are associated with postoperative morbidity. Recent studies suggest that inflammatory and immune imbalance may play an important role in postoperative complications. Studies point to new parameters derived from preoperative complete blood count as potential biomarkers of inflammation and oxidative stress. Many markers such as Neutrophil/Lymphocyte ratio, Mean platelet volume (MPV) or RDW alone have been studied in cardiac surgery. The ratio of red cell distribution width (RDW) to lymphocyte (L) has been popular in recent years as an indicator of poor prognosis, especially in oncological patients. However, this marker has not yet been evaluated in terms of morbidity or mortality in cardiac surgery patients.
The main purpose of this study; To investigate the RDW/L ratio as an early morbidity marker in cardiac surgery patients.
- Conditions
- Cardiac Surgery
- Keywords
- red cell distribution width, lymphocyte, postoperative complications, cardiac surgery
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative complications + | Patients who have postoperative complications during hospital stay after cardiac surgery | |
| Postoperative complications - | Patients who have not postoperative complications during hospital stay after cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
red cell distribution width (RDW)
preoperative measurement of complete blood count. RDW is calculated by dividing the standard deviation of the mean cell size by the MCV of the red cells and multiplying by 100 to convert to a percentage.
Measured: preoperative period ( 24 hours before surgery)
lymphocyte count
preoperative measurement of complete blood count.
Measured: preoperative period ( 24 hours before surgery)
Complications
postoperative complications such as pulmonary, neurologic, cardiac, infectious.
Measured: postoperative periods, up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start15 Jun 2022
- Primary completion1 Jul 2022
- Study completion1 Aug 2022
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 Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Balcı, Ankara City Hospital Bilkent
- Investigators
- ZELİHA A DEMİR, Professor, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341037
- Sponsor's protocol ID
- MH2.7
- Status last verified
- Aug 2022
- First submitted
- 17 Apr 2022
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aydinli B, Demir A, Guclu CY, Bolukbasi D, Unal EU, Koculu R, Selcuk G. Hematological predictors and clinical outcomes in cardiac surgery. J Anesth. 2016 Oct;30(5):770-8. doi: 10.1007/s00540-016-2197-y. Epub 2016 Jun 9.
PubMed 27282623Unal EU, Ozen A, Kocabeyoglu S, Durukan AB, Tak S, Songur M, Kervan U, Birincioglu CL. Mean platelet volume may predict early clinical outcome after coronary artery bypass grafting. J Cardiothorac Surg. 2013 Apr 16;8:91. doi: 10.1186/1749-8090-8-91.
PubMed 23590976Huang J, Zhao Y, Liao L, Liu S, Lu S, Wu C, Wei C, Xu S, Zhong H, Liu J, Guo Y, Zhang S, Gao F, Tang W. Evaluation of Red Cell Distribution Width to Lymphocyte Ratio as Potential Biomarker for Detection of Colorectal Cancer. Biomed Res Int. 2019 Jul 31;2019:9852782. doi: 10.1155/2019/9852782. eCollection 2019.
PubMed 31467924Ma C, Liu Q, Li C, Cheng J, Liu D, Yang Z, Yan H, Wu B, Wu Y, Zhao J. Novel Blood Indicators of Progression and Prognosis in Renal Cell Carcinoma: Red Cell Distribution Width-to-Lymphocyte Ratio and Albumin-to-Fibrinogen Ratio. J Oncol. 2020 Nov 25;2020:2895150. doi: 10.1155/2020/2895150. eCollection 2020.
PubMed 33299415
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Biomarker for the Prediction of Early Comorbidity in Cardiac Surgery: Red Cell Distribution With to Lymphocyte Ratio
- ClinicalTrials.gov ID
- NCT05341037
- Acronym / sponsor ID
- MH2.7
- Conditions
- Cardiac Surgery
- Keywords
- red cell distribution width, lymphocyte, postoperative complications, cardiac surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 22 Apr 2022 (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.
It is aimed to investigate whether red cell distribution with (RDW) to lymphocyte ratio (RLR) can predict early comorbidity among cardiac surgery patients.
Detailed description
There are important developments in the field of cardiac surgery due to advances in medical treatments, surgical techniques, intraoperative anesthesia management, and postoperative intensive care. On the other hand, the proportion of high-risk patients has increased due to the increasing number of elderly patients with comorbidities presenting for cardiac surgery. It is important to analyze outcomes such as postoperative morbidity and mortality, due to concerns about the quality of life of patients after cardiac operations, the recommendations of current ERAS protocols, and the shortening of intensive care unit length of stay. Complications such as cardiac, pulmonary, renal, and neurological disorders, infections such as pneumonia or sepsis, and prolonged stay in the intensive care unit and hospital are indicators of not only the quality of care but also the quality of life after cardiac surgery. Therefore, it is important to determine the perioperative risk factors that cause postoperative morbidity. Various outcome prediction models are used for cardiac surgery, such as the Cardiac Anesthesia Risk Assessment score, Tuman score, Tu score, and the European System for Cardiac Operative Risk Assessment score, which uses preoperative factors to predict the postoperative outcomes. It is known that intraoperative factors such as CPB duration, aortic cross-clamp time, surgical technique, and serum lactate levels are associated with postoperative morbidity. Recent studies suggest that inflammatory and immune imbalance may play an important role in postoperative complications. Studies point to new parameters derived from preoperative complete blood count as potential biomarkers of inflammation and oxidative stress. Many markers such as Neutrophil/Lymphocyte ratio, Mean platelet volume (MPV) or RDW alone have been studied in cardiac surgery. The ratio of red cell distribution width (RDW) to lymphocyte (L) has been popular in recent years as an indicator of poor prognosis, especially in oncological patients. However, this marker has not yet been evaluated in terms of morbidity or mortality in cardiac surgery patients.
The main purpose of this study; To investigate the RDW/L ratio as an early morbidity marker in cardiac surgery patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postoperative complications + | – | –Patients who have postoperative complications during hospital stay after cardiac surgery |
| Postoperative complications - | – | –Patients who have not postoperative complications during hospital stay after cardiac surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone open-heart surgery with cardiopulmonary bypass in our hospital within the last year will be evaluated retrospectively.
Key inclusion criteria (1 listed)
- Adult patients undergoing open-heart surgery with cardiopulmonary bypass
Key exclusion criteria (7 listed)
- Re-operations
- Emergency operations
- Patients with preoperative renal failure
- Patients with preoperative hematological problems
- Patients with preoperative infection
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
red cell distribution width (RDW)
Time frame: preoperative period ( 24 hours before surgery)
preoperative measurement of complete blood count. RDW is calculated by dividing the standard deviation of the mean cell size by the MCV of the red cells and multiplying by 100 to convert to a percentage.
lymphocyte count
Time frame: preoperative period ( 24 hours before surgery)
preoperative measurement of complete blood count.
Complications
Time frame: postoperative periods, up to 7 days
postoperative complications such as pulmonary, neurologic, cardiac, infectious.
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 8 Aug 2022.
- Results publication: PubMed 27282623Aydinli B, Demir A, Guclu CY, Bolukbasi D, Unal EU, Koculu R, Selcuk G. Hematological predictors and clinical outcomes in cardiac surgery. J Anesth. 2016 Oct;30(5):770-8. doi: 10.1007/s00540-016-2197-y. Epub 2016 Jun 9.
- Results publication: PubMed 23590976Unal EU, Ozen A, Kocabeyoglu S, Durukan AB, Tak S, Songur M, Kervan U, Birincioglu CL. Mean platelet volume may predict early clinical outcome after coronary artery bypass grafting. J Cardiothorac Surg. 2013 Apr 16;8:91. doi: 10.1186/1749-8090-8-91.
- Results publication: PubMed 31467924Huang J, Zhao Y, Liao L, Liu S, Lu S, Wu C, Wei C, Xu S, Zhong H, Liu J, Guo Y, Zhang S, Gao F, Tang W. Evaluation of Red Cell Distribution Width to Lymphocyte Ratio as Potential Biomarker for Detection of Colorectal Cancer. Biomed Res Int. 2019 Jul 31;2019:9852782. doi: 10.1155/2019/9852782. eCollection 2019.
- Results publication: PubMed 33299415Ma C, Liu Q, Li C, Cheng J, Liu D, Yang Z, Yan H, Wu B, Wu Y, Zhao J. Novel Blood Indicators of Progression and Prognosis in Renal Cell Carcinoma: Red Cell Distribution Width-to-Lymphocyte Ratio and Albumin-to-Fibrinogen Ratio. J Oncol. 2020 Nov 25;2020:2895150. doi: 10.1155/2020/2895150. eCollection 2020.
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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.
ZELİHA A DEMİR, Professor principal investigator
Ankara City Hospital Bilkent
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 Cardiac Surgery, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 7 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 8 Aug 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 Turkey (Türkiye). 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?
red cell distribution width (RDW) (time frame: preoperative period ( 24 hours before surgery)). The study lists 3 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 NCT05341037, 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 8 Aug 2022.