Comparison of Enteral Versus Intravenous Potassium Supplementation (EIPS)

Aga Khan University

Status and phase: Unknown; Phase 4

Conditions: Acute Hypokalemia

Treatments: Drug: Oral potassium chloride; Drug: Intravenous potassium chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT02015962

EIPS

Details and patient eligibility

About

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)

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 1 day to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Intravenous potassium

Experimental group

Description:

Patients in this arm will be administered intravenous potassium if they develop hypokalemia. As per CICU protocol 1-ml blood sample from already placed art-line or central venous line is sent for analysis of serum potassium concentration in all the immediate post operative patients. In the IVPR group, potassium will be given according to the hospital protocol through a central line. As per a previously established protocol and bioavailability data, repeat serum potassium will be sent 1 hour after replacement in the IVPR group.

Treatment:

Drug: Intravenous potassium chloride

Enteral potassium (ERP)

Experimental group

Description:

Once included in the study, patients in this arm will be given oral potassium if they develop an episode of hypokalemia. As per CICU protocol 1-ml blood sample from already placed art-line or central venous line is sent for analysis of serum potassium concentration in all the immediate post operative patients. As per a previously established protocol and bioavailability data, repeat serum potassium will be sent 2 hours after replacement in the EPR group. Replacement and serum level monitoring will be done till the episode of hypokalemia is resolved

Treatment:

Drug: Oral potassium chloride