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Completed

NCT Number: NCT05341037

Red Cell Distribution With to Lymphocyte Ratio in Cardiac Surgery

It is aimed to investigate whether red cell distribution with (RDW) to lymphocyte ratio (RLR) can predict early comorbidity among cardiac surgery patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara City Hospital

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients undergoing open-heart surgery with cardiopulmonary bypass

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

  2. lymphocyte count

    Time frame: preoperative period ( 24 hours before surgery)

    preoperative measurement of complete blood count.

  3. Complications

    Time frame: postoperative periods, up to 7 days

    postoperative complications such as pulmonary, neurologic, cardiac, infectious.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

A Novel Biomarker for the Prediction of Early Comorbidity in Cardiac Surgery: Red Cell Distribution With to Lymphocyte Ratio

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 22, 2022
Registry last updated
Aug 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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