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

Respiratory Failure Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04705701
• Other study ID #: earlydialysis2021
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 2, 2021

Study information

• Verified date: December 2022
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2, 2021
• Est. primary completion date: September 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coagulopathy
• Respiratory Failure
• Respiratory Insufficiency
• Shock

Intervention

Procedure:
• Hemodialysis
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	A minimum of 1 day up to 7 days
Primary	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	A minimum of 1 day up to 7 days
Secondary	blood product requirement postoperatively	coagulopathy and platelet dysfunction in end stage kidney disease patients being corrected faster with early dialysis	A minimum of 1 day up to 7 days