Management of Hypokalemia in Intensive Care Patients

NCT07833722 | Completed

• 1 other identifier: E-782624
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hypokalemia; Intensive Care Unit (ICU); Intensive Care Unit (ICU) Patients

Keywords

Intensive care unit; hypokalemia; potassium replacement treatment protocol; clinical pharmacist

Outcome Measures

Primary Outcomes (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.

  30 days

Secondary Outcomes (18)

• 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.

Study Arms (2)

Hypokalemia Treatment Algorithm

EXPERIMENTAL

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

Standart Care

NO INTERVENTION

Patients who received standard routine potassium replacement without the application of the developed treatment algorithm.

Interventions

Implementation of hypokalemia treatment algorithm OTHER

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

Hypokalemia Treatment Algorithm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anadolu University: lead

Study Sites (1)

The study was conducted in a 102-bed general intensive care unit at a state hospital in Eskisehir, Turkey.

Eskişehir, Tepebasi, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypokalemia

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 22, 2026
• Study Start: September 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)