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

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Northwell Health

Status

Withdrawn

Conditions

Coagulopathy
Shock
Respiratory Failure

Treatments

Procedure: Hemodialysis

Study type

Interventional

Funder types

Other

Identifiers

NCT04705701
earlydialysis2021

Details and patient eligibility

About

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

Full 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

Sex

All

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups

Arm A group participants receive same day post-op dialysis
Experimental group
Description:
Arm A group participants receive same day post-op dialysis
Treatment:
Procedure: Hemodialysis
Arm B group participants receive dialysis per standard care
No Intervention group
Description:
Arm B group participants receive dialysis per standard care

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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