心脏手术后重症监护病房小儿低钾血症患者肠内与静脉补钾的比较：开放标签随机等效性试验（EIPS）

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

作者信息

Rehman Siddiqu Naveed Ur, Merchant Quratulain, Hasan Babar S, Rizvi Arjumand, Amanullah Muneer, Rehmat Amina, Ul Haq Anwarul

机构信息

Department of Pediatrics and Child Health, Aga Khan University Hospital, Karachi, Pakistan.

Department of Surgery, Aga Khan University, Karachi, Pakistan.

出版信息

BMJ Open. 2017 May 10;7(5):e011179. doi: 10.1136/bmjopen-2016-011179.

DOI:10.1136/bmjopen-2016-011179

PMID:28495809

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5736091/

Abstract

OBJECTIVES

The 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 DESIGN

The EIPS trial is designed as a randomised, equivalence trial between two treatment arms.

STUDY SETTING

The study was conducted at the paediatric cardiac intensive care unit (PCICU) at Aga Khan University Hospital, Karachi.

PARTICIPANTS

41 patients (aged 1 month to 15 years) who were admitted to PCICU post cardiac surgery were recruited (23 IVPR arm and 18 EPR arm).

INTERVENTION

Intervention arms were block randomised on alternate weeks for IVPR and EPR.

OUTCOME MEASURE

Change in serum potassium levels in (mmol/L) and percentage change after each event of potassium replacement by the intravenous or enteral route.

RESULTS

Both 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).

CONCLUSION

EPR may be an equally efficacious alternative first-line therapy in treating hypokalaemia after surgery in selective patients with congenital heart disease.

ETHICS AND DISSEMINATION

This study has been approved by Ethics Review Committee at AKU.

TRIAL REGISTRATION NUMBER

NCT02015962.

摘要

目的

主要目的是比较肠内补钾（EPR）和静脉补钾（IVPR）作为一线治疗的疗效。次要目的包括比较不良反应以及纠正低钾血症发作所需的剂量数。

试验设计

EIPS试验设计为两个治疗组之间的随机等效性试验。

研究地点

该研究在卡拉奇阿迦汗大学医院的儿科心脏重症监护病房（PCICU）进行。

参与者

招募了41例心脏手术后入住PCICU的患者（年龄1个月至15岁）（IVPR组23例，EPR组18例）。

干预措施

干预组每隔一周进行IVPR和EPR的区组随机分组。

观察指标

血清钾水平的变化（mmol/L）以及通过静脉或肠内途径每次补钾事件后的百分比变化。

结果

两组（41例患者）具有相似的基线特征。平均年龄为4.7（标准差±4）岁，最常见的手术是室间隔缺损修复术（12例患者，29.3%）。两组均未观察到死亡病例。EPR组出现4次呕吐发作和1次心律失常。在调整年龄、发作开始时的钾水平、平均尿量、肌力评分和利尿剂剂量后，发现EPR和IVPR后钾水平变化无统计学显著差异：分别为0.86 mmol/L（±0.8）和0.82 mmol/L（±0.7）（p = 0.86，95%可信区间-0.08至1.10），或肠内和静脉补钾后钾水平的百分比变化：26%（±30）和24%（±20）（95%可信区间-3.42至4.03，p = 0.87）。