Comparison of Enteral Versus Intravenous Potassium Supplementation

• Status: Unknown status
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aga Khan University

Criteria

Inclusion Criteria:

• • All patients undergoing surgical repair/palliation of congenital heart lesion at the Aga Khan University Hospital and admitted to the pediatric cardiac intensive care unit (PCICU) for post-operative management.

• Serum potassium levels (<4.39 meq/l) immediate post operatively

• Patients/parents willing to participate in the study

• Have a central venous line for IVPR and an arterial line for monitoring and blood draws.

• Able to tolerate oral or nasogastric administration of medication for EPR.

Exclusion Criteria:

• • Patients with acute renal failure (estimated clearance creatinine - eccr <50)

• Patients with paralytic ileus, necrotizing enterocolitis or GI bleeding.

• Patients with nausea, vomiting or diarrhea prior to randomization. Patients will not be excluded if these symptoms develop during the trial after the initial recruitment. Based on clinical decision the route of potassium supplementation may be changed if these symptoms. Intention to treat analysis will be used for the primary end point.

• Patient with symptomatic hypokalemia (manifested as a rhythm disturbances).

• Initial serum K level (post surgery) < 2.0 mEq