TY - JOUR
T1 - Comparison of Enteral versus Intravenous Potassium Supplementation in hypokalaemia in postcardiac surgery paediatric cardiac intensive care patients
T2 - Prospective open label randomised control trial (EIPS)
AU - Merchant, Quratulain
AU - Siddiqui, Naveed Ur Rehman
AU - Rehmat, Amina
AU - Amanullah, Muneer
AU - Ul Haq, Anwar
AU - Hasan, Babar
N1 - Publisher Copyright:
© 2014, BMJ Publishing Group. All rights reserved.
PY - 2014
Y1 - 2014
N2 - Background: Hypokalaemia is frequently encountered in the daily clinical practices of a paediatric cardiac intensive care unit (PCICU). It is a strong independent predictor of mortality in patients with heart failure. Thus, prompt potassium replacement therapy holds pivotal importance in therapy for hypokalaemia. Although intravenous potassium replacement (IVPR) in hypokalaemia is the preferred route in most intensive care settings, it is associated with known safety risks and can lead to arrhythmias, cardiac arrest and death if inappropriately administered. Enteral potassium replacement (EPR), with its superior safety profile, may be a better alternative to IVPR. Outcome: Primary outcome To compare the efficacy EPR and IVPR for treatment of hypokalaemia. Secondary outcome measures include a comparison of adverse effects (hyperkalaemia, diarrhoea, gastrointestinal bleeds, nausea and vomiting) after EPR and IVPR and a comparison of the number of dose/s required to achieve resolution of hypokalaemia for each episode of hypokalaemia. Methods and analysis: The Enteral Versus Intravenous Potassium Supplementation trial is designed as a randomised, controlled, non-blinded trial with two arms. Intervention arms will be block randomised on alternate weeks for IVPR and EPR. Recruited patients will receive treatment accordingly. For analysis, the percentage change in serum potassium levels in mEq/L after each event of potassium replacement in both arms will be used as an end point to compare the efficacy EPR and IVPR for treatment of hypokalaemia. Study setting: The study will be conducted at the PCICU at the Aga Khan University Hospital, Karachi. Ethics and dissemination: This study has been approved by the Ethics Review Committee and Clinical Trials Unit at The Aga Khan University with respect to scientific content and compliance with applicable research and human subjects regulations. Trial registration number: This trial is registered at Clinical Trials.Gov. Registration number: NCT02015962.
AB - Background: Hypokalaemia is frequently encountered in the daily clinical practices of a paediatric cardiac intensive care unit (PCICU). It is a strong independent predictor of mortality in patients with heart failure. Thus, prompt potassium replacement therapy holds pivotal importance in therapy for hypokalaemia. Although intravenous potassium replacement (IVPR) in hypokalaemia is the preferred route in most intensive care settings, it is associated with known safety risks and can lead to arrhythmias, cardiac arrest and death if inappropriately administered. Enteral potassium replacement (EPR), with its superior safety profile, may be a better alternative to IVPR. Outcome: Primary outcome To compare the efficacy EPR and IVPR for treatment of hypokalaemia. Secondary outcome measures include a comparison of adverse effects (hyperkalaemia, diarrhoea, gastrointestinal bleeds, nausea and vomiting) after EPR and IVPR and a comparison of the number of dose/s required to achieve resolution of hypokalaemia for each episode of hypokalaemia. Methods and analysis: The Enteral Versus Intravenous Potassium Supplementation trial is designed as a randomised, controlled, non-blinded trial with two arms. Intervention arms will be block randomised on alternate weeks for IVPR and EPR. Recruited patients will receive treatment accordingly. For analysis, the percentage change in serum potassium levels in mEq/L after each event of potassium replacement in both arms will be used as an end point to compare the efficacy EPR and IVPR for treatment of hypokalaemia. Study setting: The study will be conducted at the PCICU at the Aga Khan University Hospital, Karachi. Ethics and dissemination: This study has been approved by the Ethics Review Committee and Clinical Trials Unit at The Aga Khan University with respect to scientific content and compliance with applicable research and human subjects regulations. Trial registration number: This trial is registered at Clinical Trials.Gov. Registration number: NCT02015962.
UR - http://www.scopus.com/inward/record.url?scp=84930363172&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2014-005124
DO - 10.1136/bmjopen-2014-005124
M3 - Article
C2 - 25190615
AN - SCOPUS:84930363172
SN - 2044-6055
VL - 4
JO - BMJ Open
JF - BMJ Open
M1 - e005124
ER -