From Consensus to Clinical Practice: Impact of a Clinical Pharmacist-Supported Hypokalemia Management Algorithm in Critically Ill Patients-A Prospective Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Development of an Expert Consensus-Based Hypokalemia Treatment Algorithm
研究概览
简要总结
Hypokalemia is a common electrolyte disorder in critically ill patients and may contribute to substantial morbidity and mortality if inadequately managed. Standardized approaches to hypokalemia management in intensive care units (ICUs) remain limited.
This study aimed to develop an expert consensus-based hypokalemia treatment algorithm and to evaluate its implementation with clinical pharmacist involvement in critically ill patients.
The study was conducted in the general ICU of a state hospital and consisted of two phases. In the first phase, recommendations derived from current clinical guidelines, relevant literature, and clinical practice were evaluated through a two-round expert consensus process involving specialist physicians and clinical pharmacists with ICU experience. Consensus-based recommendations were used to develop a standardized hypokalemia treatment algorithm.
In the second phase, a prospective before-and-after design was used to compare routine ICU care with algorithm-guided hypokalemia management accompanied by clinical pharmacist recommendations. Prespecified outcomes included initiation and timing of potassium replacement therapy, achievement of normokalemia, time to normokalemia, recurrent hypokalemia, treatment-associated hyperkalemia, normokalemia at ICU discharge, and ICU length of stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older
- •Admission to the ICU
- •ICU stay longer than 24 hours
- •Documented hypokalemia defined as serum potassium concentration of less than 3.5 mEq/L
排除标准
- •Diabetic ketoacidosis
- •Active coronary artery disease
- •Severe renal impairment (GFR less than 15 mL/min/1,73 m²)
- •Malignant disease
- •Presence of a cardiac pacemaker
- •ICU admission following major surgery
- •Receipt of dialysis therapy
- •Hypokalemia managed primarily via potassium supplementation added to total parenteral nutrition
研究组 & 干预措施
Standart Care
Patients who received standard routine potassium replacement without the application of the developed treatment algorithm.
Hypokalemia Treatment Algorithm
Implementation of a protocol-driven hypokalemia replacement algorithm collaboratively guided by a physician and a clinical pharmacist to standardize potassium replacement regimens.
干预措施: Implementation of hypokalemia treatment algorithm (Other)
结局指标
主要结局
Development of an Expert Consensus-Based Hypokalemia Treatment Algorithm
时间窗: 30 days
A standardized hypokalemia treatment algorithm for critically ill patients was developed through a two-round expert panel process. Recommendations regarding the diagnosis, treatment, and monitoring of hypokalemia were evaluated using structured electronic questionnaires. For each recommendation, the Content Validity Ratio (CVR) was calculated as (Ne - N/2)/(N/2), where Ne was the number of panelists rating the recommendation as necessary and N was the total number of participating panelists. The minimum acceptable CVR was determined according to the total number of panelists participating in the corresponding survey round. Recommendations with a calculated CVR exceeding the applicable minimum CVR value were considered necessary and were included in the hypokalemia management algorithm.
次要结局
- Percentage of Patients With Severe Hypokalemia Receiving Serum Potassium Reassessment 6 Hours After Intravenous Potassium Administration(6 hours after intravenous potassium administration for each severe hypokalemia episode.)
- Percentage of Patients With Hypokalemia Who Received Potassium Replacement Therapy(From the first documented hypokalemia episode until ICU discharge or death, an average of 30 days)
- Time From Identification of Hypokalemia to Initiation of Potassium Replacement Therapy(From identification of the hypokalemia episode to administration of the first dose of potassium replacement therapy during the ICU stay, an average of 24 hours.)
- Percentage of Patients Achieving Normokalemia After Potassium Replacement Therapy(From initiation of potassium replacement therapy until achievement of normokalemia, ICU discharge, or death, whichever occurred first. An average of 30 days.)
- Time From Initiation of Potassium Replacement Therapy to Achievement of Normokalemia(From initiation of potassium replacement therapy to the first documented serum potassium concentration of 3.5-5.0 mEq/L during the ICU stay, an average of 48 hours.)
- Duration of Normokalemia After Potassium Replacement Therapy(From the first documented achievement of normokalemia until the first subsequent serum potassium measurement outside the normokalemic range, ICU discharge, or death, whichever occurred first. An average of 30 days.)
- Percentage of Patients With Recurrent Hypokalemia After Achievement of Normokalemia(From the first documented achievement of normokalemia until ICU discharge or death. An average of 30 days.)
- Percentage of Patients Developing Hyperkalemia During or After Potassium Replacement Therapy(From initiation of potassium replacement therapy up to 7 days.)
- Percentage of Patients With Normokalemia at ICU Discharge(At ICU discharge, an average of 30 days.)
- Intensive Care Unit Length of Stay(From ICU admission until ICU discharge or death, an average of 30 days.)
- Number of Hypokalemia Episodes During the ICU Stay(From ICU admission until ICU discharge or death, an average of 30 days.)
- Number of Hyperkalemia Episodes During the ICU Stay(From ICU admission until ICU discharge or death, an average of 30 days.)
- Change in Serum Potassium Concentration After Potassium Replacement Therapy(From the serum potassium measurement immediately before potassium replacement therapy to the first serum potassium measurement after treatment during the ICU stay, an average of 24 hours.)
- Percentage of Patients With Mild-to-Moderate Hypokalemia Receiving Daily Serum Potassium Monitoring(From identification of mild-to-moderate hypokalemia until achievement of normokalemia, ICU discharge, or death, whichever occurred first. An average of 30 days.)
- Percentage of Patients Receiving Prespecified Laboratory Monitoring During Hypokalemia Management(From the first documented hypokalemia episode until ICU discharge or death, an average of 30 days.)
- Percentage of Eligible Patients Receiving Arterial Blood Gas Assessment(From identification of severe or persistent hypokalemia until achievement of normokalemia, ICU discharge, or death, whichever occurred first. An average of 30 days.)
- Percentage of Patients With Severe or Symptomatic Hypokalemia Receiving Electrocardiographic Assessment(From identification of severe or symptomatic hypokalemia until achievement of normokalemia, ICU discharge, or death, whichever occurred first. An average of 30 days.)
- Percentage of Patients Receiving Continuous ECG Monitoring During High-Rate Intravenous KCl Infusion Exceeding 20 mmol/hour(During intravenous KCl infusion at a rate >20 mmol/hour, an average of 30 days.)