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Completed

NCT Number: NCT02672930

How Much Reliable iv Calcium for the Treatment of Hyperkalemia?

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrocardiogram (ECG)

Device

ECG and vital parameters were obtained before and after recommended standard calcium gluconate therapy for hyperkalemia

Primary outcomes

  1. ECG changes after the calcium infusion

    Time frame: 10 minutes

Secondary outcomes

  1. Pulse changes after the calcium infusion

    Time frame: 10 minutes

  2. Blood pressure changes after the calcium infusion

    Time frame: 10 minutes

Sponsors and collaborators

Lead sponsor

Haseki Training and Research Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Feb 3, 2016
Registry last updated
Mar 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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