Acute Renal FailureNCT02672930
How Much Reliable iv Calcium for the Treatment of Hyperkalemia?
An observational study of Acute Renal Failure and Chronic Renal Failure, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Renal Failure, Chronic Renal Failure
- What is being tested?
- Electrocardiogram (ECG)
- Type of treatment
- Medical device
- How many people
- 111 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2015to Jul 2017
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Blood potassium levels above 5.5 and all patients with ECG changes due hyperpotassemia were included in the study.
Who may be able to join
- All patients who had ECG changes due to hyperpotassemia (K>5.5 mmol/l)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Training and Reseurch Hospital
Istanbul, 34096
About this study
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.
Read the 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.
- Conditions
- Acute Renal Failure, Chronic Renal Failure
- Being tested
- Electrocardiogram (ECG)
- Keywords
- calcium gluconate, hyperpotassemia treatment
- Medical subject headings
- Acute Kidney Injury, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrocardiogram (ECG)Device
ECG and vital parameters were obtained before and after recommended standard calcium gluconate therapy for hyperkalemia
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG changes after the calcium infusion
Measured: 10 minutes
Secondary outcomes (2)
Pulse changes after the calcium infusion
Measured: 10 minutes
Blood pressure changes after the calcium infusion
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startJul 2015
- Primary completionJul 2016
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adnan Yamanoğlu, Haseki Training and Research Hospital
- Investigators
- Adnan Yamanoğlu, MD, Principal investigator, Emergency Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672930
- Sponsor's protocol ID
- 230
- Status last verified
- Sep 2020
- First submitted
- 17 Jan 2016
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Much Reliable iv Calcium for the Treatment of Hyperkalemia?
- ClinicalTrials.gov ID
- NCT02672930
- Acronym / sponsor ID
- 230
- Conditions
- Acute Renal Failure, Chronic Renal Failure
- Keywords
- calcium gluconate, hyperpotassemia treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Blood potassium levels above 5.5 and all patients with ECG changes due hyperpotassemia were included in the study.
Key inclusion criteria (1 listed)
- All patients who had ECG changes due to hyperpotassemia (K>5.5 mmol/l)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrocardiogram (ECG)ECG and vital parameters were obtained before and after recommended standard calcium gluconate therapy for hyperkalemia | Device | – |
Primary outcome
ECG changes after the calcium infusion
Time frame: 10 minutes
2 secondary outcomes
Pulse changes after the calcium infusion
Time frame: 10 minutes
Blood pressure changes after the calcium infusion
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adnan Yamanoğlu, MD principal investigator
Emergency Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Renal Failure and Chronic Renal Failure, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECG changes after the calcium infusion (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.