Management of Hypokalemia in Intensive Care Patients
From Consensus to Clinical Practice: Impact of a Clinical Pharmacist-Supported Hypokalemia Management Algorithm in Critically Ill Patients-A Prospective Controlled Study
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tepebasi
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Eskişehir, Tepebasi, Turkey (Türkiye)
- The study was conducted in a 102-bed general intensive care unit at a state hospital in Eskisehir, Turkey.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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. |
Implementation of a protocol-driven hypokalemia treatment algorithm collaboratively guided by a physician and a clinical pharmacist to standardize potassium replacement regimens. |
|
No Intervention: Standart Care
Patients who received standard routine potassium replacement without the application of the developed treatment algorithm. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Development of an Expert Consensus-Based Hypokalemia Treatment Algorithm
Time Frame: 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. |
30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Patients With Hypokalemia Who Received Potassium Replacement Therapy
Time Frame: From the first documented hypokalemia episode until ICU discharge or death, an average of 30 days
|
The percentage of patients with documented hypokalemia, defined as a serum potassium concentration <3.5 mEq/L, who received potassium replacement therapy during the ICU stay. Receipt of potassium replacement therapy was assessed using electronic health records and medication administration records. The numerator was the number of patients with documented hypokalemia who received potassium replacement therapy, and the denominator was the total number of patients with documented hypokalemia. The outcome was expressed as a percentage (%). |
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
Time Frame: 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.
|
The time elapsed between identification of hypokalemia, defined as a serum potassium concentration <3.5 mEq/L, and administration of the first dose of potassium replacement therapy. The time of serum potassium measurement and the time of potassium administration were obtained from laboratory records and medication administration records. The outcome was expressed in hours. |
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.
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Percentage of Patients Achieving Normokalemia After Potassium Replacement Therapy
Time Frame: From initiation of potassium replacement therapy until achievement of normokalemia, ICU discharge, or death, whichever occurred first. An average of 30 days.
|
The percentage of patients who achieved normokalemia after initiation of potassium replacement therapy. Normokalemia was defined as a serum potassium concentration of 3.5-5.0 mEq/L and was assessed using laboratory serum potassium measurements. The numerator was the number of treated patients who achieved normokalemia, and the denominator was the total number of patients who received potassium replacement therapy. The outcome was expressed as a percentage (%). |
From initiation of potassium replacement therapy until achievement of normokalemia, ICU discharge, or death, whichever occurred first. An average of 30 days.
|
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Time From Initiation of Potassium Replacement Therapy to Achievement of Normokalemia
Time Frame: 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.
|
The time elapsed between initiation of potassium replacement therapy and the first subsequent serum potassium measurement within the normokalemic range of 3.5-5.0 mEq/L. Potassium administration times and serum potassium concentrations were obtained from medication administration records and laboratory records. The outcome was expressed in hours. |
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.
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Duration of Normokalemia After Potassium Replacement Therapy
Time Frame: 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.
|
The duration for which serum potassium remained within the normokalemic range of 3.5-5.0 mEq/L after achievement of normokalemia following potassium replacement therapy. Serum potassium concentrations were obtained from laboratory records. Duration was calculated from the first documented normokalemic serum potassium measurement to the first subsequent measurement outside the normokalemic range, ICU discharge, or death, whichever occurred first. The outcome was expressed in hours. |
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.
|
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Percentage of Patients With Recurrent Hypokalemia After Achievement of Normokalemia
Time Frame: From the first documented achievement of normokalemia until ICU discharge or death. An average of 30 days.
|
The percentage of patients who developed a new hypokalemia episode after previously achieving normokalemia. Normokalemia was defined as a serum potassium concentration of 3.5-5.0 mEq/L, and recurrent hypokalemia was defined as a subsequent serum potassium concentration <3.5 mEq/L after documented achievement of normokalemia. Consecutive serum potassium measurements <3.5 mEq/L without an intervening normokalemic measurement were considered part of the same hypokalemia episode and were not classified as recurrence. The numerator was the number of patients who developed at least one recurrent hypokalemia episode, and the denominator was the number of patients who achieved normokalemia. The outcome was expressed as a percentage (%). |
From the first documented achievement of normokalemia until ICU discharge or death. An average of 30 days.
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Percentage of Patients Developing Hyperkalemia During or After Potassium Replacement Therapy
Time Frame: From initiation of potassium replacement therapy up to 7 days.
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The percentage of patients who developed hyperkalemia during or after potassium replacement therapy. Hyperkalemia was defined as a serum potassium concentration >5.0 mEq/L and was assessed using laboratory serum potassium measurements. The numerator was the number of treated patients who developed hyperkalemia, and the denominator was the total number of patients who received potassium replacement therapy. The outcome was expressed as a percentage (%). |
From initiation of potassium replacement therapy up to 7 days.
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Percentage of Patients With Normokalemia at ICU Discharge
Time Frame: At ICU discharge, an average of 30 days.
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The percentage of patients whose last available serum potassium concentration before ICU discharge was within the normokalemic range of 3.5-5.0 mEq/L. Serum potassium concentrations were obtained from laboratory records. The numerator was the number of discharged patients whose last available serum potassium concentration was within the normokalemic range, and the denominator was the total number of patients discharged from the ICU with an available serum potassium measurement. The outcome was expressed as a percentage (%). |
At ICU discharge, an average of 30 days.
|
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Intensive Care Unit Length of Stay
Time Frame: From ICU admission until ICU discharge or death, an average of 30 days.
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The duration of ICU hospitalization was calculated from the date and time of ICU admission to the date and time of ICU discharge or death using electronic health records. The outcome was expressed in days. |
From ICU admission until ICU discharge or death, an average of 30 days.
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Number of Hypokalemia Episodes During the ICU Stay
Time Frame: From ICU admission until ICU discharge or death, an average of 30 days.
|
The number of hypokalemia episodes per patient during the ICU stay was determined using laboratory serum potassium measurements. Hypokalemia was defined as a serum potassium concentration <3.5 mEq/L. A hypokalemia episode began with the first serum potassium measurement <3.5 mEq/L and continued until normokalemia, defined as a serum potassium concentration of 3.5-5.0 mEq/L, was achieved. Consecutive serum potassium measurements <3.5 mEq/L before achievement of normokalemia were considered part of the same episode and were not counted as separate episodes. A new hypokalemia episode was counted when serum potassium subsequently decreased to <3.5 mEq/L after documented achievement of normokalemia. The outcome was expressed as the number of hypokalemia episodes per patient. |
From ICU admission until ICU discharge or death, an average of 30 days.
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Number of Hyperkalemia Episodes During the ICU Stay
Time Frame: From ICU admission until ICU discharge or death, an average of 30 days.
|
The number of hyperkalemia episodes per patient during the ICU stay was determined using laboratory serum potassium measurements. Hyperkalemia was defined as a serum potassium concentration >5.0 mEq/L. A hyperkalemia episode began with the first serum potassium measurement >5.0 mEq/L and continued until serum potassium returned to the normokalemic range of 3.5-5.0 mEq/L. Consecutive serum potassium measurements >5.0 mEq/L before achievement of normokalemia were considered part of the same episode and were not counted as separate episodes. A new hyperkalemia episode was counted when serum potassium subsequently increased to >5.0 mEq/L after documented achievement of normokalemia. The outcome was expressed as the number of hyperkalemia episodes per patient. |
From ICU admission until ICU discharge or death, an average of 30 days.
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Change in Serum Potassium Concentration After Potassium Replacement Therapy
Time Frame: 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.
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The change in serum potassium concentration was calculated as the first serum potassium concentration measured after potassium replacement therapy minus the serum potassium concentration measured immediately before initiation of potassium replacement therapy. Serum potassium concentrations were obtained from laboratory records. The outcome was expressed in mEq/L. |
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.
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Percentage of Patients With Mild-to-Moderate Hypokalemia Receiving Daily Serum Potassium Monitoring
Time Frame: From identification of mild-to-moderate hypokalemia until achievement of normokalemia, ICU discharge, or death, whichever occurred first. An average of 30 days.
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The percentage of patients with mild hypokalemia, defined as a serum potassium concentration of 3.0-3.4 mEq/L, or moderate hypokalemia, defined as 2.5-2.9 mEq/L, who underwent serum potassium measurement at least once daily while hypokalemia persisted. Monitoring was assessed using laboratory records. The numerator was the number of eligible patients who received serum potassium monitoring at least once daily, and the denominator was the total number of patients with mild-to-moderate hypokalemia. The outcome was expressed as a percentage (%). |
From identification of mild-to-moderate hypokalemia until achievement of normokalemia, ICU discharge, or death, whichever occurred first. An average of 30 days.
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Percentage of Patients With Severe Hypokalemia Receiving Serum Potassium Reassessment 6 Hours After Intravenous Potassium Administration
Time Frame: 6 hours after intravenous potassium administration for each severe hypokalemia episode.
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The percentage of patients with severe hypokalemia, defined as a serum potassium concentration <2.5 mEq/L, who underwent repeat serum potassium measurement 6 hours after intravenous potassium administration. Serum potassium measurements and intravenous potassium administration times were assessed using laboratory records and medication administration records. The numerator was the number of eligible patients who underwent the specified 6-hour serum potassium reassessment, and the denominator was the total number of patients with severe hypokalemia who received intravenous potassium. The outcome was expressed as a percentage (%). |
6 hours after intravenous potassium administration for each severe hypokalemia episode.
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Percentage of Patients Receiving Prespecified Laboratory Monitoring During Hypokalemia Management
Time Frame: From the first documented hypokalemia episode until ICU discharge or death, an average of 30 days.
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The percentage of patients with hypokalemia who underwent measurement of the prespecified laboratory parameters during the diagnosis and management of hypokalemia. The parameters included urea, serum sodium, serum magnesium, and serum glucose. Monitoring was assessed using laboratory records. The numerator was the number of patients with documented measurement of all prespecified laboratory parameters, and the denominator was the total number of patients with documented hypokalemia. The outcome was expressed as a percentage (%). |
From the first documented hypokalemia episode until ICU discharge or death, an average of 30 days.
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Percentage of Eligible Patients Receiving Arterial Blood Gas Assessment
Time Frame: From identification of severe or persistent hypokalemia until achievement of normokalemia, ICU discharge, or death, whichever occurred first. An average of 30 days.
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The percentage of patients with severe hypokalemia, defined as a serum potassium concentration <2.5 mEq/L, or hypokalemia persisting despite potassium replacement therapy who underwent arterial blood gas analysis. Arterial blood gas testing was assessed using laboratory records. The numerator was the number of eligible patients who underwent arterial blood gas analysis, and the denominator was the total number of patients meeting either indication for arterial blood gas assessment. The outcome was expressed as a percentage (%). |
From identification of severe or persistent hypokalemia until achievement of normokalemia, ICU discharge, or death, whichever occurred first. An average of 30 days.
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Percentage of Patients With Severe or Symptomatic Hypokalemia Receiving Electrocardiographic Assessment
Time Frame: From identification of severe or symptomatic hypokalemia until achievement of normokalemia, ICU discharge, or death, whichever occurred first. An average of 30 days.
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The percentage of patients with severe hypokalemia, defined as a serum potassium concentration <2.5 mEq/L, or symptomatic hypokalemia who underwent at least one electrocardiogram (ECG). ECG assessment was determined using electronic health records and ECG records. The numerator was the number of eligible patients who underwent at least one ECG, and the denominator was the total number of patients with severe or symptomatic hypokalemia. The outcome was expressed as a percentage (%). |
From identification of severe or symptomatic hypokalemia until achievement of normokalemia, ICU discharge, or death, whichever occurred first. An average of 30 days.
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Percentage of Patients Receiving Continuous ECG Monitoring During High-Rate Intravenous KCl Infusion Exceeding 20 mmol/hour
Time Frame: During intravenous KCl infusion at a rate >20 mmol/hour, an average of 30 days.
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The percentage of patients receiving intravenous potassium chloride (KCl) at an infusion rate >20 mmol/hour who underwent continuous ECG monitoring during the infusion. KCl infusion rates and continuous ECG monitoring were assessed using medication administration records and electronic health records. The numerator was the number of eligible patients who received continuous ECG monitoring, and the denominator was the total number of patients receiving intravenous KCl at an infusion rate >20 mmol/hour. The outcome was expressed as a percentage (%). |
During intravenous KCl infusion at a rate >20 mmol/hour, an average of 30 days.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-782624
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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