How Much Reliable iv Calcium for the Treatment of Hyperkalemia?

Completed

• Conditions: Acute Renal Failure; Chronic Renal Failure

• Registration Number: NCT02672930
• Lead Sponsor: Haseki Training and Research Hospital

Brief Summary

Hyperkalemia is a common problem in the emergency services and one of the life threatening metabolic emergencies. Calcium, insulin, beta adrenoceptor agonists, bicarbonate, diuretics, sodium polystyrene sulfonate and lastly dialysis are advised in treatment. Especially, avoiding evolution of serious arrythmias and iv calcium using in the treatment of occured electrocardiogram (ECG) abnormalities, there is not sufficient level of survey in the literature. So the aim of this study was to evaluate administration of iv calcium efficiency on vital signs and ECG.

Detailed Description

Hyperkalemia is a common problem in the emergency services and one of the life threatening metabolic emergencies. Serious hyperkalemia is mostly seen in patients who have known chronic renal failure or end stage renal disease, and also new diagnosis of acute renal failure can be appear with serious hyperkalemia. Paresthesia and weakness which is proceeded to flask paralysis can be observable, sharp ''T'' waves (the repolarization and relaxation of the ventricles), diminution of ''P'' waves (atrial depolarisation and contraction), long ''PR'' intervals (time frame from the beginning of atrial depolarization to the beginning of ventricular depolarization), or elongated ''QRS'' complexes (depolarisation and contraction of the ventricles), ''ST'' segment (end of the QRS complex to the beginning of the T wave) elevation, and serious ventricular arrythmias can be seen in electrocardiography. Calcium, insulin, beta adrenoceptor agonists, bicarbonate, diuretics, sodium polystyrene sulfonate and lastly dialysis are advised in treatment. Especially, avoiding evolution of serious arrythmias and İv calcium using in the treatment of occured ''ECG'' abnormalities, there is not sufficient level of survey in the literature. The group of Cochrane stated in systematic assessment report, which is published in 2005 about IV calcium administration, available dates are based on anecdotal and animal experiments. And in the researches that we have done, we did not find clinical human studies showing the benefits of calcium administration beyond the delivery of case reports . The aim of this study was to evaluate administration of İv calcium efficiency on vital signs and ECG.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2016-01-17
• Study First Submitted QC: 2016-01-29
• Study First Posted: 2016-02-03
• Primary Completion: 2016-07
• Study Completion: 2017-07
• Status Verified: 2020-09
• Last Update Submitted: 2021-02-28
• Last Update Posted: 2021-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

• All patients who had ECG changes due to hyperpotassemia (K>5.5 mmol/l)

Exclusion Criteria

• Arrest patients
• Patients needed antiarrhythmic interventions
• Patients need inotropic that may cause ECG changes
• Patients need atropine during emergency treatment prior to Ca-gluconate
• Patients needed cardioversion or defibrillation
• Hyperpotassemia with myocardial infarction
• In the presence of other situations which changes ECG for example pericarditis
• Unstabile patients for ideal ECG
• Digoxin usage
• Trauma
• blood calcium level of > 10.5 mg/dl

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ECG changes after the calcium infusion	10 minutes

Secondary Outcome Measures

Name	Time	Method
Blood pressure changes after the calcium infusion	10 minutes
Pulse changes after the calcium infusion	10 minutes

Trial Locations

Locations (1)

Haseki Training and Reseurch Hospital; 🇹🇷 Istanbul, Turkey