Fluid Chloride and AKI in Cardiopulmonary Bypass

Completed · Phase 2

Conditions studied: Acute Kidney Injury

In brief

Acute kidney injury (AKI) is a potential complication of cardiac surgery. In animal models, excess exogenous Cl- ion in the bloodstream is associated with AKI. Normal saline IV fluid has higher levels of Cl- ion than the blood usually carries. An alternative IV fluid sold under the name Isolyte has lower Cl- ion levels. There is no literature comparing AKI outcomes in cardiac patients between patients receiving normal saline vs. Isolyte. The investigators propose to recruit and randomize 30 trial-completing cardiac surgery patients (up to 40 enrolled) into 2 study arms and compare renal outcomes.

Key facts

Study ID

NCT02668952

Run by

University of New Mexico

People needed

30

Starts

2016-01-01

Expected to finish

2018-02-01

Last updated by the study team

2018-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Planned on- or off-pump cardiac surgery including: bypass grafting, valvular procedures, congenital defect correction, and thoracic aortic procedures or a combination of these procedures

You may not qualify if…

• Emergency surgery
• Pregnancy
• Previous renal transplantation
• Documented moderate to severe acute kidney injury prior to enrollment (e.g. RIFLE-I or RIFLE-F/KDIGO stage 2 or 3)
• Patients already receiving dialysis (acute or chronic) or in imminent need of dialysis at time of enrollment
• Chronic kidney disease without baseline serum creatinine value obtained within 6 months of enrollment

Where it is running

• University of New Mexico Hospital — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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