Clinical trial NCT02015962: Comparison of Enteral Versus Intravenous Potassium Supplementation
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Hypokalemia
Keywords: Hypokalemia
Intravenous
Enteral
post-cardiac surgery
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2013-12-19
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Eligibility 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

Primary outcomes:
measure: The efficacy EPR and IVPR for treatment of hypokalemia (measured as change in serum potassium levels in milliequivalent/liter (mEq/L) after potassium replacement
timeFrame: 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.
Secondary outcomes:
measure: Comparison of adverse effects after EPR and IVPR.
timeFrame: 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.
measure: Comparison of number of dose/s required to achieve resolution of hypokalemia
timeFrame: 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.
measure: Efficacy of EPR and IVPR for various degrees of severity of hypokalemia for each episode of hypokalemia
timeFrame: 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.
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: CICU- Aga Khan University Hospital
state: Sindh
city: Karachi
country: Pakistan
facility: The Aga Khan University
state: Sindh
city: Karachi
country: Pakistan
facility: The Aga Khan University
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Anwarul Haq, MD
role: STUDY_DIRECTOR
References:
citation: Rehman Siddiqu NU, Merchant Q, Hasan BS, Rizvi A, Amanullah M, Rehmat A, Ul Haq A. Comparison of enteral versus intravenous potassium supplementation in hypokalaemia in paediatric patients in intensive care post cardiac surgery: open-label randomised equivalence trial (EIPS). BMJ Open. 2017 May 10;7(5):e011179. doi: 10.1136/bmjopen-2016-011179.
citation: Merchant Q, Rehman Siddiqui NU, Rehmat A, Amanullah M, Haq AU, Hasan B. Comparison of Enteral versus Intravenous Potassium Supplementation in hypokalaemia in postcardiac surgery paediatric cardiac intensive care patients: prospective open label randomised control trial (EIPS). BMJ Open. 2014 Sep 4;4(9):e005124. doi: 10.1136/bmjopen-2014-005124.