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How Much Reliable iv Calcium for the Treatment of Hyperkalemia?

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ClinicalTrials.gov Identifier: NCT02672930
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : August 16, 2016
Sponsor:
Information provided by (Responsible Party):
Adnan Yamanoğlu, 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.

Condition or disease Intervention/treatment
Acute Renal Failure Chronic Renal Failure Device: Electrocardiogram (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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: How Much Reliable iv Calcium for the Treatment of Hyperkalemia?
Study Start Date : July 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium


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


Primary Outcome Measures :
  1. ECG changes after the calcium infusion [ Time Frame: 10 minutes ]

Secondary Outcome Measures :
  1. Pulse changes after the calcium infusion [ Time Frame: 10 minutes ]
  2. Blood pressure changes after the calcium infusion [ Time Frame: 10 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Blood potassium levels above 6.5 and all patients with ECG changes due hyperpotassemia were included in the study.
Criteria

Inclusion Criteria:

  • Blood Potassium level was found >6,5 in the biochemistry tests
  • All patients who had ECG changes due to hyperpotassemia

Exclusion Criteria:

  • Arrest patients
  • Patients needed antiarrhythmic interventions
  • Patients need inotropic that may cause ECG changes
  • Hyperpotassemia with myocardial infarction
  • In the presence of other situations which changes ECG for example pericarditis
  • Unstabile patients for ideal ECG

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672930


Locations
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Turkey
Haseki Training and Reseurch Hospital
Istanbul, Turkey, 34096
Sponsors and Collaborators
Haseki Training and Research Hospital
Investigators
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Principal Investigator: Adnan Yamanoğlu, MD Emergency Department
Additional Information:

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Responsible Party: Adnan Yamanoğlu, Emergency Medicine Specialist, Haseki Training and Research Hospital
ClinicalTrials.gov Identifier: NCT02672930    
Other Study ID Numbers: 230
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Adnan Yamanoğlu, Haseki Training and Research Hospital:
calcium gluconate
hyperpotassemia treatment
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Acute Kidney Injury
Hyperkalemia
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Water-Electrolyte Imbalance
Metabolic Diseases