Clinical Trial: Comparison of Enteral Versus Intravenous Potassium Supplementation

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Comparison of Enteral Versus Intravenous Potassium Supplementation in Hypokalemia in Post Cardiac Surgery Pediatric Cardiac Intensive Care Patients - Prospective Open Labe

Brief 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 Summary:

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


Sponsor: Aga Khan University

Current Primary Outcome: The efficacy EPR and IVPR for treatment of hypokalemia (measured as change in serum potassium levels in milliequivalent/liter (mEq/L) after potassium replacement [ Time Frame: The primary endpoint will be assessed every 1 hour in the IVPR group and every 2 hour in the EPR group after replacement of potassium. The patients will be followed for the duration of CICU stay which will be around 1 week. ]

The intervention arms will be blocked randomized as alternate week for I/V and enteral potassium replacement for trial's operational feasibility. Recruited patients will receive treatment accordingly.

In case where a patient develops side effects such as diarrhea or vomiting, even though he will be changed to IV route of potassium supplement, he will be considered enteral supplementation during data analysis till the point when the patient had received enteral replacement.

In the IVPR group, potassium will be given according to the hospital protocol through a central line. As per a previously established protocol, repeat serum potassium will be sent 1 hour after replacement in the IVPR group and 2 hours after replacement in the EPR group. Replacement and serum level monitoring will be done till the episode of hypokalemia is resolved.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Comparison of adverse effects after EPR and IVPR. [ Time Frame: Adverse events will be monitored every 2 hours after potassium supplementation. The patients will be followed for the duration of CICU stay which will be around 1 week. ]
    Adverse effects that will be monitored are hyperkalemia (defined as potassium levels > 5 mEq/L, arrhythmias (defined as any rhythm other than sinus during or within 2 hours of potassium replacement), diarrhea (described as > 2 loose stools or a single watery stool, during or within 2 hours of potassium replacement , GI bleeds, nausea and vomiting (during or within 2 hours of potassium replacement). These adverse events will be monitored on hourly bases by the CICU nursing staff as per CICU protocol. These adverse events will be documented on the CICU nursing sheet (as per routine) and the data gathered every morning by the principal or co-investigators. The on-call physician will be contacted, as per routine, by the nursing to determine any change in mode/dose of potassium replacement if adverse events occur. The on-call physician will in-turn contact either the principal or one of the co-investigators to further discuss the plan.
  • Comparison of number of dose/s required to achieve resolution of hypokalemia [ Time Frame: Dose administration(one hour after IV and two hours after enteral) will be continued till the episode of hypokalemia resolves. Each episode will last ~ 5 hours. The patients will be followed for the duration of CICU stay which will be around 1 week. ]
  • Efficacy of EPR and IVPR for various degrees of severity of hypokalemia for each episode of hypokalemia [ Time Frame: An episode of hypokalemia would last ~ 5 hours. The patients will be followed for the duration of CICU stay which will be around 1 week. ]
    Degree of severity: Mild, moderate or severe as determined by the protocol.


Original Secondary Outcome: Same as current

Information By: Aga Khan University

Dates:
Date Received: November 20, 2013
Date Started: October 2013
Date Completion: May 2014
Last Updated: December 14, 2013
Last Verified: December 2013