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Withdrawn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
About this trial
This is an interventional prevention trial for Respiratory Failure
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
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
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Withdrawn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Trial was withdrawn due to Covid-19 pandemic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
Learn more about this trial
Comparing Post Cardiac Surgery Outcomes in ESRD Patient's With Early Dialysis Versus Standard Care
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