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Comparing Post Cardiac Surgery Outcomes in ESRD Patient's With Early Dialysis Versus Standard Care

Primary Purpose

Respiratory Failure, Shock, Coagulopathy

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hemodialysis
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Failure

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All post operative cardiac surgery ESRD patients who are not meeting exclusion criteria (mentioned below) would be included in the study

Exclusion Criteria:

  • hyperkalemia serum K>5.5, severe acidosis PH < 7.2, clinical evidences of volume

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Arm A group participants receive same day post-op dialysis

    Arm B group participants receive dialysis per standard care

    Arm Description

    Arm A group participants receive same day post-op dialysis

    Arm B group participants receive dialysis per standard care

    Outcomes

    Primary Outcome Measures

    length of mechanical ventilation
    the duration of mechanical ventilation related to pulmonary congestion in anuric end stage kidney disease patients affected by early dialysis and fluid overload optimization
    intensive care unit (ICU) stay
    following above, requirement for mechanical ventilation support and pulmonary edema affected by early dialysis helping fluid overload optimization and earlier weaning from ventilator, therefor shorter ICU stay

    Secondary Outcome Measures

    blood product requirement postoperatively
    coagulopathy and platelet dysfunction in end stage kidney disease patients being corrected faster with early dialysis

    Full Information

    First Posted
    December 7, 2020
    Last Updated
    December 15, 2022
    Sponsor
    Northwell Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04705701
    Brief Title
    Comparing Post Cardiac Surgery Outcomes in ESRD Patient's With Early Dialysis Versus Standard Care
    Official Title
    Randomized Controlled Trial of Post Cardiac Surgery Outcomes in End Stage Renal Disease Patients Comparing Early Dialysis on the Day of Surgery Versus Standard Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Trial was withdrawn due to Covid-19 pandemic
    Study Start Date
    September 1, 2021 (Anticipated)
    Primary Completion Date
    September 2, 2021 (Anticipated)
    Study Completion Date
    September 2, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Northwell Health

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    End-stage renal disease (ESRD) is an important risk factor for coronary and valvular cardiac disease leading to cardiac surgery. with concern for higher post-op complications with volume overload and coagulopathies in this patient' outcomes as mentioned above in patients who receive early post-op dialysis versus hemodialysis on day 1 or thereafter. ed for mechanical ventilation and rs of clinical course and mortality. Previous studies have demonstrated that presence of ESRD is an independent risk factor for post-operative respiratory failure and mortality in patients undergoing cardiac surgery, partially mediated through volume overload and prolonged mechanical ventilation, as well as coagulopathy attributed to platelet dysfunction and uremia. Prolonged mechanical ventilation after cardiac surgery has been shown to be associated with higher morbidity and mortality. Fluid overload is a predictor of length of mechanical ventilation and intensive care unit (ICU) stay. Therefore early restoration of volume and electrolyte homeostasis and clearance of uremic toxins should be one of the principal goals in the immediate post operative period in patients with ESRD. However, to the best of our knowledge, the effect of timing of post-operative renal replacement therapy, specifically hemodialysis, on clinical outcomes has not been studied in ESRD patients undergoing cardiac surgery. Accordingly, we have conducted this study to evaluate the effect of early population affecting their overall hospital course including longer duration of ICU stay, need for mechanical ventilation support and blood products transfusion we are planning to conduct this study and compare the short term hemodialysis treatment after cardiac surgery, on clinical outcomes related to volume overload and coagulopathy (i.e. duration of mechanical ventilation, transfusion requirements, and length of ICU stay) in patients with ESRD
    Detailed Description
    End-stage renal disease (ESRD) is an important risk factor for coronary and valvular cardiac disease leading to cardiac surgery. Both volume overload and coagulopathy in the immediate post-operative period after cardiac surgery are important predictors of clinical course and mortality. Previous studies have demonstrated that presence of ESRD is an independent risk factor for post-operative respiratory failure and mortality in patients undergoing cardiac surgery, partially mediated through volume overload and prolonged mechanical ventilation, as well as coagulopathy attributed to platelet dysfunction and uremia. Prolonged mechanical ventilation after cardiac surgery has been shown to be associated with higher morbidity and mortality. Fluid overload is a predictor of length of mechanical ventilation and intensive care unit (ICU) stay. Therefore early restoration of volume and electrolyte homeostasis and clearance of uremic toxins should be one of the principal goals in the immediate post operative period in patients with ESRD. However, to the best of our knowledge, the effect of timing of post-operative renal replacement therapy, specifically hemodialysis, on clinical outcomes has not been studied in ESRD patients undergoing cardiac surgery. Accordingly, we are planning to conduct this study to evaluate the effect of early hemodialysis treatment after cardiac surgery, on clinical outcomes related to volume overload and coagulopathy (i.e. duration of mechanical ventilation, transfusion requirements, and length of ICU stay) in patients with ESRD

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Respiratory Failure, Shock, Coagulopathy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm A group participants receive same day post-op dialysis
    Arm Type
    Experimental
    Arm Description
    Arm A group participants receive same day post-op dialysis
    Arm Title
    Arm B group participants receive dialysis per standard care
    Arm Type
    No Intervention
    Arm Description
    Arm B group participants receive dialysis per standard care
    Intervention Type
    Procedure
    Intervention Name(s)
    Hemodialysis
    Intervention Description
    Renal replacement therapy is considered standard of care for end stage renal disease patients for clearing the blood and also helping with volume optimization, has different modalities, in our study we are using intermittent hemodialysis.
    Primary Outcome Measure Information:
    Title
    length of mechanical ventilation
    Description
    the duration of mechanical ventilation related to pulmonary congestion in anuric end stage kidney disease patients affected by early dialysis and fluid overload optimization
    Time Frame
    A minimum of 1 day up to 7 days
    Title
    intensive care unit (ICU) stay
    Description
    following above, requirement for mechanical ventilation support and pulmonary edema affected by early dialysis helping fluid overload optimization and earlier weaning from ventilator, therefor shorter ICU stay
    Time Frame
    A minimum of 1 day up to 7 days
    Secondary Outcome Measure Information:
    Title
    blood product requirement postoperatively
    Description
    coagulopathy and platelet dysfunction in end stage kidney disease patients being corrected faster with early dialysis
    Time Frame
    A minimum of 1 day up to 7 days

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All post operative cardiac surgery ESRD patients who are not meeting exclusion criteria (mentioned below) would be included in the study Exclusion Criteria: hyperkalemia serum K>5.5, severe acidosis PH < 7.2, clinical evidences of volume
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maria DeVita, MD
    Organizational Affiliation
    Lenox Hill Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Comparing Post Cardiac Surgery Outcomes in ESRD Patient's With Early Dialysis Versus Standard Care

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