Continuous Renal Replacement Therapy in the Setting of Orthotopic Liver Transplant

NCT01619449 — Not applicable, Withdrawn, University of Chicago

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Continuous Renal Replacement Therapy in the Setting of Orthotopic Liver Transplant: A Randomized Trial

Registry	NCT01619449
Status	Withdrawn - Research never begun and no subjects enrolled. Protocol term with IRB in Dec 2014
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Sponsor	University of Chicago (Other)
Conditions	Acute Kidney Injury, Liver Disease, Chronic Kidney Disease, End Stage Kidney Disease
Interventions	Renal replacement therapy (Procedure)
Dates	start 2012-04-01, primary completion 2014-12-01, completion 2014-12-01, first posted 2012-06-14, last updated 2015-05-27
Locations	1 site in United States

-Summary

To evaluate the efficacy of continuous renal replacement therapy (CRRT) during orthotopic liver transplantation (OLT) in clearing excess solutes and improving acid-base parameters. The investigators hypothesize that the use of intra-operative CRRT in OLT recipients is associated with increased solute removal and improved acid-base statues when compared to controls who do not receive CRRT

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+Detailed description

as above

+Arms and interventions

Arm	Type	Interventions	Description
Renal replacement therapy	Experimental	Procedure: Renal replacement therapy	Liver transplant recipients who receive continuous renal replacement therapy intra-operatively.
No CRRT	Active comparator	Procedure: Renal replacement therapy	This arm consists of standard of care without CRRT in the OR for OLT

Renal replacement therapy (Procedure): Liver transplant recipients receiving continuous renal replacement therapy for duration of liver transplant surgery.

+Outcome measures

Primary outcomes

Solute Clearance [Intra-operative time]: To compare the clearance of solutes (ie. potassium, lactate, creatinine and blood urea nitrogen) by CRRT in renally impaired OLT recipients to OLT recipients who do not receive CRRT

Secondary outcomes

Renal function and patient outcomes [1 year post-operatively]: To compare long-term maintenance of renal function (12 months) and other health outcomes in OLT recipients who received CRRT versus OLT recipients who did not receive OLT

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Age 18 or older and able to sign consent (or surrogate)
* Receiving liver or combined liver-kidney transplant
* eGFR < or equal to 40 ml/min immediately prior to transplant or currently on any form of renal replacement therapy for acute kidney injury or end-stage renal disease
* Pre-operative potassium of < or equal to 5.5 mEq/L

Exclusion Criteria:

* Pre-operative hemoglobin < or equal to 7 g/dL
* Pre-operative weight > or equal to 125 kig

+Locations (1)

Facility	City	Country	Status
University of Chicago Medicine	Chicago, Illinois	United States

+Investigators

Jay L Koyner, MD, Principal investigator, University of Chicago