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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02672930
Other study ID # 230
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2015
Est. completion date July 2017

Study information

Verified date September 2020
Source Haseki Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 111
Est. completion date July 2017
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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


Intervention

Device:
Electrocardiogram (ECG)
ECG and vital parameters were obtained before and after recommended standard calcium gluconate therapy for hyperkalemia

Locations

Country Name City State
Turkey Haseki Training and Reseurch Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Haseki Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary ECG changes after the calcium infusion 10 minutes
Secondary Pulse changes after the calcium infusion 10 minutes
Secondary Blood pressure changes after the calcium infusion 10 minutes
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