NCT02015962

Comparison of Enteral Versus Intravenous Potassium Supplementation

Comparison of Enteral Versus Intravenous Potassium Supplementation in Hypokalemia in Post Cardiac Surgery Pediatric Cardiac Intensive Care Patients - Prospective Open Label Randomized Control Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Aga Khan University · Academic / Other
• Sex: All
• Age: 1 Day – 25 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

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

Conditions

• Acute Hypokalemia

Interventions

Type	Name	Description
DRUG	Intravenous potassium chloride
DRUG	Oral potassium chloride

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2013-12-19
• Last updated: 2013-12-19

Locations

3 sites across 1 country: Pakistan