NCT02672930

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

March 2, 2021

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

January 17, 2016

Last Update Submit

February 28, 2021

Conditions

Keywords

calcium gluconatehyperpotassemia treatment

Outcome Measures

Primary Outcomes (1)

  • ECG changes after the calcium infusion

    10 minutes

Secondary Outcomes (2)

  • Pulse changes after the calcium infusion

    10 minutes

  • Blood pressure changes after the calcium infusion

    10 minutes

Interventions

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Blood potassium levels above 5.5 and all patients with ECG changes due hyperpotassemia were included in the study.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haseki Training and Reseurch Hospital

Istanbul, 34096, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Kidney InjuryKidney Failure, Chronic

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRenal Insufficiency, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • Adnan Yamanoğlu, MD

    Emergency Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emergency Medicine Specialist

Study Record Dates

First Submitted

January 17, 2016

First Posted

February 3, 2016

Study Start

July 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2017

Last Updated

March 2, 2021

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations