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HypokalemiaNCT07833722

Management of Hypokalemia in Intensive Care Patients

A study testing Implementation of hypokalemia treatment algorithm in people with Hypokalemia and Intensive Care Unit (ICU), run by Anadolu University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Implementation of hypokalemia treatment algorithm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2024to 1 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • The study was conducted in a 102-bed general intensive care unit at a state hospital in Eskisehir, Turkey.

    Eskişehir, Tepebasi

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read more

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.

Being tested
Implementation of hypokalemia treatment algorithm
Keywords
Intensive care unit, hypokalemia, potassium replacement treatment protocol, clinical pharmacist
Medical subject headings
Hypokalemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implementation of hypokalemia treatment algorithmOther

    Implementation of a protocol-driven hypokalemia treatment algorithm collaboratively guided by a physician and a clinical pharmacist to standardize potassium replacement regimens.

Study groups in NCT07833722
Study groupRoleWhat they receive
Hypokalemia Treatment AlgorithmExperimentalImplementation of a protocol-driven hypokalemia replacement algorithm collaboratively guided by a physician and a clinical pharmacist to standardize potassium replacement regimens.
Receives: Other: Implementation of hypokalemia treatment algorithm
Standart CareNo interventionPatients who received standard routine potassium replacement without the application of the developed treatment algorithm.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30 days

Secondary outcomes (18)
  1. 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 (%).

    Measured: From the first documented hypokalemia episode until ICU discharge or death, an average of 30 days

  2. 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.

    Measured: 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.

  3. 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 (%).

    Measured: From initiation of potassium replacement therapy until achievement of normokalemia, ICU discharge, or death, whichever occurred first. An average of 30 days.

  4. 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.

    Measured: 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.

  5. 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.

    Measured: 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.

  6. 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 (%).

    Measured: From the first documented achievement of normokalemia until ICU discharge or death. An average of 30 days.

  7. 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 (%).

    Measured: From initiation of potassium replacement therapy up to 7 days.

  8. 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 (%).

    Measured: At ICU discharge, an average of 30 days.

  9. 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.

    Measured: From ICU admission until ICU discharge or death, an average of 30 days.

  10. 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.

    Measured: From ICU admission until ICU discharge or death, an average of 30 days.

  11. 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.

    Measured: From ICU admission until ICU discharge or death, an average of 30 days.

  12. 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.

    Measured: 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.

  13. 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 (%).

    Measured: From identification of mild-to-moderate hypokalemia until achievement of normokalemia, ICU discharge, or death, whichever occurred first. An average of 30 days.

  14. 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 (%).

    Measured: 6 hours after intravenous potassium administration for each severe hypokalemia episode.

  15. 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 (%).

    Measured: From the first documented hypokalemia episode until ICU discharge or death, an average of 30 days.

  16. 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 (%).

    Measured: From identification of severe or persistent hypokalemia until achievement of normokalemia, ICU discharge, or death, whichever occurred first. An average of 30 days.

  17. 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 (%).

    Measured: From identification of severe or symptomatic hypokalemia until achievement of normokalemia, ICU discharge, or death, whichever occurred first. An average of 30 days.

  18. 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 (%).

    Measured: During intravenous KCl infusion at a rate >20 mmol/hour, an average of 30 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2026
  2. Study start1 Sep 2024
  3. Primary completion1 Aug 2025
  4. Study completion1 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07833722
Sponsor's protocol ID
E-782624
Status last verified
Sep 2026
First submitted
2 Sep 2026
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Implementation of hypokalemia treatment algorithm in people with Hypokalemia and Intensive Care Unit (ICU), run by Anadolu University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Development of an Expert Consensus-Based Hypokalemia Treatment Algorithm (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

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