An interventional study of Lower Dose Therapy and Conventional Dose Therapy in Hyperkalemia, sponsored by University of Malaya. Enrolling by invitation at 1 site in Malaysia. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by University of Malaya · Not applicable, Interventional, and Treatment
This clinical trial aims to evaluate the safety and efficacy of a lower dose insulin compared to the conventional dose for treating mild to moderate hyperkalemia, a condition characterized by elevated serum potassium levels below 6.4 mmol/L. The study focuses on adult patients in the emergency department.
The primary objective is to determine whether the efficacy of lower doses of insulin and dextrose is non-inferior to conventional doses in reducing serum potassium levels in patients with mild to moderate hyperkalemia.
The research compares two regimens: 5 units of insulin with 25 mL of dextrose 50% versus 10 units of insulin with 50 mL of dextrose 50%, assessing the mean reduction in serum potassium levels, the incidence of hypoglycemia, and the risk of extravasation injury.
Participants will be monitored in the emergency department for 6 hours. Serum potassium levels will be measured at 1, 2, 4, and 6 hours post-intervention, while blood glucose levels will be monitored at 30, 60, 90, 120, 240, 300, and 360 minutes post-intervention.
The primary research question that guided the design of this study arose from the consideration of optimizing insulin and dextrose dosing in the management of mild to moderate hyperkalaemia, specifically in patients with serum potassium levels below 6.4 mmol/L. This focus acknowledges that severe hyperkalaemia necessitates higher insulin doses, often accompanied by a corresponding increase in dextrose, to achieve a rapid and significant reduction in serum potassium levels. However, the necessity of administering the full conventional dose of insulin and dextrose in moderate hyperkalaemia is still unclear. Investigators hypothesize that a lower dose regimen may achieve similar efficacy in reducing serum potassium levels while potentially minimizing the risks associated with higher doses, such as hypoglycaemia and extravasation injury.
Previous studies have reported reductions in potassium ranging from 0.6-1.17 mmol/L following administration of lower dose of insulin. In this study, investigators aim to assess whether lower doses of insulin and dextrose are non-inferior to the standard dosing regimen. The non-inferiority margin has been defined as a reduction in serum potassium by 0.5 mmol/L for both treatment groups. This margin was carefully selected because a 0.5 mmol/L decrease in potassium is clinically significant, shifting the condition from moderate to mild hyperkalaemia, thereby reducing the risk of life-threatening arrhythmias. This threshold prioritises patient safety while potentially minimising adverse events, particularly hypoglycaemia, commonly linked to higher insulin doses.
Furthermore, if the lower doses are shown to be non-inferior, adverse events such as hypoglycaemia and extravasation could be reduced, enhancing the safety profile of hyperkalaemia management. This improvement represents a key secondary objective of the study and underscores the broader potential of dose optimisation.
Research specifically addressing optimal insulin dosing for hyperkalaemia is limited. Given limited research on optimal insulin dosing for hyperkalaemia, these findings could inform clinical guidelines, encouraging flexible, evidence-based dosing strategies in emergency and critical care settings
To determine the required sample size for this non-inferiority study comparing insulin dosages for treating moderate hyperkalaemia in the emergency department, investigators utilized a sample size calculation based on the method by Julious, 2004 and the following parameters.
Investigators aimed to detect whether the mean difference between the standard treatment and the experimental treatment does not exceed the non-inferiority limit of 0.5 mmol/L, with 80% power and a significance level of 0.05 for a two-sided test. Estimating a standard deviation of 0.68 mmol/L based on prior studies, and using the formula for comparing two means, 23 participants per arm are needed.
Including a 10% dropout rate, the total sample size required for the study is 50 participants, with 25 allocated to each treatment group.
133 studies on the registry are indexed under Hyperkalemia; 25 are open to participants now.
This study's planned enrollment of 50 is below the median of 87 across 102 interventional studies indexed under Hyperkalemia.
Browse Hyperkalemia studies →University of Malaya is the lead sponsor of 284 studies on the registry; 58 are open to participants now.
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Exclusion Criteria:
Traditional treatment involves a higher insulin dose with dextrose to mitigate hypoglycemia risk while effectively lowering potassium. Ingredients: Actrapid insulin, Dextrose 50% Dosage: 10 units of Actrapid insulin with 50 cc of Dextrose 50% Route of Administration: Intravenous (IV) Frequency: Administered as a single dose at the start of treatment Procedure: The conventional dose has been the standard of care but carries a significant risk of hypoglycemia.
Procedure: Conventional Dose Therapy
Standard treatment of hyperkalemia includes insulin to shift potassium intracellularly and dextrose to mitigate the risk of hypoglycemia. This arm will be active intervention which means to compare with traditional dose of insulin and investigate if lower dose of insulin is non inferior in reducing serum potassium level in patient with mild and moderate hyperkalemia. Ingredients: Actrapid insulin, Dextrose 50% Dosage: 5 units of Actrapid insulin with 25 cc of Dextrose 50% Route of Administration: Intravenous (IV) Frequency: Administered as a single dose at the start of treatment Procedure: Lower-dose insulin is administered with dextrose to potentially reduce hypoglycemic risk while achieving effective potassium reduction.
Procedure: Lower Dose Therapy
The group receiving the lower-dose therapy consists of 5 units of Actrapid (insulin) with 25cc of Dextrose 50%. This intervention is the focus of the clinical trial and is being investigated to determine if it achieves a comparable reduction in potassium levels with fewer potential complications. The aim is to establish it as a non-inferior alternative to conventional-dose therapy in the management of mild and moderate hyperkalemia.
The group receiving the conventional-dose therapy, consisting of 10 units of Actrapid (insulin) with 50cc of Dextrose 50%, which is currently in use as a standard practice in emergency departments for managing mild and moderate hyperkalemia. This dosing regimen aligns with established clinical guidelines and is widely accepted as an effective approach in controlling potassium levels.
Mean potassium difference between baseline and 1 hour post therapy
The difference in serum potassium level between baseline and one hour post therapy will be compared between the two arms
Time frame: From administration of actrapid to the first hour after administration of actrapid
Incidence of hypoglycaemia within 6 hours of insulin administration
Bedside glucose levels will be measured at 30, 60, 90, 120, 240, 300, and 360 minutes after insulin administration. Episodes of hypoglycemia (\< 4.0 mmol/L) will be recorded.
Time frame: From administration of actrapid until the 6 hours after administration of actrapid
Number of patients requiring rescue treatment for persistent hyperkalaemia (> 5.7 mmol/L) despite initial treatment
Patients requiring rescue treatment for hyperkalemia, in both arms, will be documented and analyzed in this study
Time frame: From administration of actrapid until the 6 hours after administration of actrapid
Mortality in patients within 7 days
Any reported mortality within 7 days as documented in the Electronic Medical Records, will be recorded and analyzed in the study.
Time frame: From enrolment to 7 days after receiving interventional treatment
Plan to share: Yes — Yes, individual participant data (IPD) will be shared. This includes de-identified participant data, study protocol, and statistical analysis plan. Data will be shared with researchers upon request and approval of a study proposal. Sharing will occur after publication of the trial results and will be made available via a secure data repository.
Supporting information: Study protocol, Informed consent form
Time frame: Beginning 3 months and ending 3 years after the publication of results
Access criteria: De-identified Individual Participant Data (IPD), including demographic data, serum potassium levels, blood glucose levels, and treatment outcomes, will be shared with qualified researchers who submit a scientifically sound proposal. Researchers must provide detailed objectives, planned analyses, and compliance with ethical and privacy standards. Study Protocol and Informed Consent Form (ICF) will be available upon request. Proposals should be submitted via email to the Principal Investigator.
Started Apr 2025 (actual). Primary completion is estimated for Jun 2027, 25 months after the start.
Of 16 interventional studies with no phase under Hyperkalemia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 28. This study's planned 25 months is close to that.
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