Comparison of enteral versus intravenous potassium supplementation in hypokalaemia in paediatric patients in intensive care post cardiac surgery: open-label randomised equivalence trial (EIPS)

• Published in: BMJ open 2017-05, Vol.7 (5), p.e011179-e011179
• Main Authors: Rehman Siddiqu, Naveed ur, Merchant, Quratulain, Hasan, Babar S, Rizvi, Arjumand, Amanullah, Muneer, Rehmat, Amina, ul Haq, Anwarul
• Format: Article
• Language: English
• Subjects: Administration, Intravenous; Adolescent; Bias; Cardiac arrhythmia; Cardiac Surgical Procedures - adverse effects; Cardiovascular disease; Cardiovascular Medicine; Child; Child, Preschool; Congenital diseases; Diarrhea; Diuretics; Diuretics - administration & dosage; Drug dosages; Enteral Nutrition - adverse effects; Evidence-based medicine; Female; Heart; Heart Defects, Congenital - surgery; Heart surgery; Humans; Hyperkalemia; Hypokalemia; Hypokalemia - drug therapy; Infant; Intensive care; Intensive Care Units, Pediatric; Male; Nausea; Pakistan; Patients; Pediatrics; Postoperative Complications - drug therapy; Postoperative period; Potassium; Potassium - administration & dosage; Potassium - blood; Prospective Studies; Regression Analysis; Severity of Illness Index; Treatment Outcome; Vomiting
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2016-011179

ObjectivesThe primary objective was to compare the efficacy of enteral potassium replacement (EPR) and intravenous potassium replacement (IVPR) as first-line therapy. Secondary objectives included comparison of adverse effects and number of doses required to resolve the episode of hypokalaemia.Trial designThe EIPS trial is designed as a randomised, equivalence trial between two treatment arms.Study settingThe study was conducted at the paediatric cardiac intensive care unit (PCICU) at Aga Khan University Hospital, Karachi.Participants41 patients (aged 1 month to 15 years) who were admitted to PCICU post cardiac surgery were recruited (23 IVPR arm and 18 EPR arm).InterventionIntervention arms were block randomised on alternate weeks for IVPR and EPR.Outcome measureChange in serum potassium levels in (mmol/L) and percentage change after each event of potassium replacement by the intravenous or enteral route.ResultsBoth groups (41 patients) had similar baseline characteristics. Mean age was 4.7 (SD±4) years while the most common surgical procedure was ventricular septal defect repair (12 patients, 29.3%). No mortality was observed in either arm. Four episodes of vomiting and one arrhythmia were seen in the EPR group. After adjusting for age, potassium level at the beginning of the episode, average urine output, inotropic score and diuretic dose, it was found that there was no statistically significant difference in change in potassium levels after EPR and IVPR: 0.86 mmol/L (±0.8) and 0.82 mmol/L (±0.7) respectively (p=0.86, 95% CI −0.08 to 1.10), or percentage change in potassium level after enteral and intravenous replacement: 26% (±30) and 24% (±20) (95% CI −3.42 to 4.03, p=0.87).ConclusionEPR may be an equally efficacious alternative first-line therapy in treating hypokalaemia after surgery in selective patients with congenital heart disease.Ethics and disseminationThis study has been approved by Ethics Review Committee at AKU.Trial registration numberNCT02015962.