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Red Cell Distribution With to Lymphocyte Ratio in Cardiac Surgery

Sponsor
Ankara City Hospital Bilkent (Other)
Overall Status
Completed
CT.gov ID
NCT05341037
Collaborator
(none)
700
Enrollment
1
Location
1.5
Actual Duration (Months)
453.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    700 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    A Novel Biomarker for the Prediction of Early Comorbidity in Cardiac Surgery: Red Cell Distribution With to Lymphocyte Ratio
    Actual Study Start Date :
    Jun 15, 2022
    Actual Primary Completion Date :
    Jul 1, 2022
    Actual Study Completion Date :
    Aug 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. red cell distribution width (RDW) [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 [preoperative period ( 24 hours before surgery)]

      preoperative measurement of complete blood count.

    3. Complications [postoperative periods, up to 7 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ankara City Hospital Ankara Turkey

    Sponsors and Collaborators

    • Ankara City Hospital Bilkent

    Investigators

    • Principal Investigator: ZELİHA A DEMİR, Professor, Ankara City Hospital Bilkent

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eda Balcı, Principal investigator, Ankara City Hospital Bilkent
    ClinicalTrials.gov Identifier:
    NCT05341037
    Other Study ID Numbers:
    • MH2.7
    First Posted:
    Apr 22, 2022
    Last Update Posted:
    Aug 8, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eda Balcı, Principal investigator, Ankara City Hospital Bilkent
    red cell distribution width
    lymphocyte
    postoperative complications
    cardiac surgery

    Study Results

    No Results Posted as of Aug 8, 2022