Acute Hypokalemia Clinical Trial
Official title:
Comparison of Enteral Versus Intravenous Potassium Supplementation in Hypokalemia in Post Cardiac Surgery Pediatric Cardiac Intensive Care Patients - Prospective Open Label Randomized Control Trial
Null hypothesis: There is no difference in the efficacy of IVPR and EPR during an episode of
hypokalemia.
Alternate Hypothesis: There is a mean difference of 15% in Serum Potassium levels between
the two groups.
Objective: To compare the efficacy EPR and IVPR for treatment of hypokalemia (measured as
change in serum potassium levels in milliequivalent/L after potassium replacement)
Hypokalemia is frequently encountered in daily clinical practices of cardiac intensive care
unit (CICU). The development of ventricular arrhythmias related to hypokalemia can lead to
sudden cardiac death. Thus, potassium replacement therapy is the cornerstone therapy for
hypokalemia.Though intravenous potassium replacement (IVPR) in hypokalemia is the preferred
route in most intensive care settings, it is associated with known safety risks.
Inappropriately administered, IVPR can lead to arrhythmias, cardiac arrest and death 1, 7,
8. Given these risks, IVPR is considered a "high-alert medication" by Institute of Safe
Medication practice.
Enteral potassium replacement (EPR), with its superior safety profile may be a better
alternative to IVPR. A retrospective review showed that the efficacy of EPR was comparable
to IVPR in pediatric patients after congenital heart disease.
The investigators seek to explore this comparison between EPR and IVPR in a randomized
prospective trial
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment