An interventional study of Implementation of hypokalemia treatment algorithm in Hypokalemia, Intensive Care Unit (ICU) and Intensive Care Unit (ICU) Patients, sponsored by Anadolu University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Anadolu University · Not applicable, Interventional, and Treatment
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.
38 studies on the registry are indexed under Hypokalemia; 5 are open to participants now.
This study's enrollment of 200 is above the median of 77 across 29 interventional studies indexed under Hypokalemia.
Browse Hypokalemia studies →Anadolu University is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Implementation of a protocol-driven hypokalemia replacement algorithm collaboratively guided by a physician and a clinical pharmacist to standardize potassium replacement regimens.
Other: Implementation of hypokalemia treatment algorithm
Patients who received standard routine potassium replacement without the application of the developed treatment algorithm.
Implementation of a protocol-driven hypokalemia treatment algorithm collaboratively guided by a physician and a clinical pharmacist to standardize potassium replacement regimens.
Development of an Expert Consensus-Based Hypokalemia Treatment Algorithm
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.
Time frame: 30 days
Percentage of Patients With Hypokalemia Who Received Potassium Replacement Therapy
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 (%).
Time frame: 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
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.
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.
Percentage of Patients Achieving Normokalemia After Potassium Replacement Therapy
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 (%).
Time frame: 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
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.
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.
Duration of Normokalemia After Potassium Replacement Therapy
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.
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.
Percentage of Patients With Recurrent Hypokalemia After Achievement of Normokalemia
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 (%).
Time frame: 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
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 (%).
Time frame: From initiation of potassium replacement therapy up to 7 days.
Percentage of Patients With Normokalemia at ICU Discharge
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 (%).
Time frame: At ICU discharge, an average of 30 days.
Intensive Care Unit Length of Stay
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.
Time frame: From ICU admission until ICU discharge or death, an average of 30 days.
Number of Hypokalemia Episodes During the ICU Stay
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.
Time frame: From ICU admission until ICU discharge or death, an average of 30 days.
Number of Hyperkalemia Episodes During the ICU Stay
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.
Time frame: From ICU admission until ICU discharge or death, an average of 30 days.
Change in Serum Potassium Concentration After Potassium Replacement Therapy
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.
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.
Percentage of Patients With Mild-to-Moderate Hypokalemia Receiving Daily Serum Potassium Monitoring
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 (%).
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.
Percentage of Patients With Severe Hypokalemia Receiving Serum Potassium Reassessment 6 Hours After Intravenous Potassium Administration
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 (%).
Time frame: 6 hours after intravenous potassium administration for each severe hypokalemia episode.
Percentage of Patients Receiving Prespecified Laboratory Monitoring During Hypokalemia Management
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 (%).
Time frame: 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
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 (%).
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.
Percentage of Patients With Severe or Symptomatic Hypokalemia Receiving Electrocardiographic Assessment
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 (%).
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.
Percentage of Patients Receiving Continuous ECG Monitoring During High-Rate Intravenous KCl Infusion Exceeding 20 mmol/hour
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 (%).
Time frame: During intravenous KCl infusion at a rate >20 mmol/hour, an average of 30 days.
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Ran from Sep 2024 to primary completion in Aug 2025, 11 months.
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