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

Sponsor
Northwell Health (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04705701
Collaborator
(none)
60
2
4.9

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Hemodialysis
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Investigator)
Primary Purpose:
Prevention
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
Anticipated Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
May 1, 2021
Anticipated Study Completion Date :
Jun 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A group participants receive same day post-op dialysis

Arm A group participants receive same day post-op dialysis

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.

No Intervention: Arm B group participants receive dialysis per standard care

Arm B group participants receive dialysis per standard care

Outcome Measures

Primary Outcome Measures

  1. length of mechanical ventilation [A minimum of 1 day up to 7 days]

    the duration of mechanical ventilation related to pulmonary congestion in anuric end stage kidney disease patients affected by early dialysis and fluid overload optimization

  2. intensive care unit (ICU) stay [A minimum of 1 day up to 7 days]

    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

  1. blood product requirement postoperatively [A minimum of 1 day up to 7 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Northwell Health

Investigators

  • Principal Investigator: Maria DeVita, MD, Lenox Hill Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Northwell Health
ClinicalTrials.gov Identifier:
NCT04705701
Other Study ID Numbers:
  • earlydialysis2021
First Posted:
Jan 12, 2021
Last Update Posted:
Feb 4, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 4, 2021