HypokalemiaPhase 4ASPICNCT00718068
Safety of Continuous Potassium Chloride Infusion in Critical Care
A Phase 4 study testing Sterile Potassium Chloride Concentrate in people with Hypokalemia and Arrhythmias, Cardiac, run by The Queen Elizabeth Hospital at 1 site in Australia.
Trial summary
Patients in critical care often require supplemental potassium chloride if levels in their blood are below acceptable level. Common practice is to administer a single dose of potassium chloride under controlled conditions via a drip, before checking if a further dose is required. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypokalemia, Arrhythmias, Cardiac
- What is being tested?
- Sterile Potassium Chloride Concentrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2008to Oct 2009
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any inpatient on the investigating unit with a serum potassium level of less than 3.8mmol/L
- arterial line for blood sampling and central venous access for infusion administration in situ
- continuous 12-lead ECG monitoring
Who cannot join
- Patients with a serum potassium ≥ 3.8mmol/L
- Renal dysfunction with serum creatinine 50% greater than the upper end of the normal reference range (i.e.: > 180micromol/L) or urine output less than 0.5ml/kg/hr for 6 consecutive hours, or the requirement for dialysis
- Burns
- Hypomagnesaemia (≤ 0.7mmol/L), however patients may be enrolled after the hypomagnesaemia is corrected
Trial locations and contacts
1 site in 1 country.
Australia1 site
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011
About this study
Official title: Assessing the Safety of a Continuous Potassium Chloride Infusion in Critical Care: A Randomised Controlled Trial
Patients in critical care often require supplemental potassium chloride if levels in their blood are below acceptable level. Common practice is to administer a single dose of potassium chloride under controlled conditions via a drip, before checking if a further dose is required. The purpose of this study is to ensure that it is safe to administer potassium chloride continuously with the dose varied according to patient needs.
Read the detailed description
The use of potassium supplementation is commonplace in the critical care environment. Patients often have abnormal serum potassium levels due to active disease processes. Conditions such as acute renal failure and metabolic acidosis precipitate hyperkalaemia, with ileus and insensible losses causing hypokalaemia. Both hypo- and hyperkalaemia can cause life-threatening arrythmias so it is prudent to rectify aberrant levels.
The standard treatment of hypokalaemia in intensive care units is by intravenous administration of potassium chloride. This can be given either as a dilute solution as maintenance intravenous fluid therapy, or as a concentrated solution by intermittent infusion. Alternatively potassium can be given as a concentrated solution by continuous infusion. All techniques require regular monitoring of the patient's serum potassium level with appropriate alterations to the administration regime.
From a theoretical standpoint it would make sense to give potassium by continuous infusion as this allow slow but steady correction of hypokalaemia. A continuous infusion should prevent rapid fluctuations in the serum level that could be caused by intermittent infusions, which may precipitate arrhythmia. However continuous infusions require vigilant monitoring to ensure that hyperkalaemia does not occur and must be given into a central vein to avoid the risk of phlebitis.
The use of intermittent infusions has been used safely in the critical care setting under physician guidance. A retrospective review reported the outcomes of the administration of 495 infusion sets to 190 individuals. While they identified 2 instances of post-infusion hyperkalaemia, neither was associated with any adverse sequelae. Analysis showed a no correlation between serum potassium increase post-infusion and serum creatinine, thus advocating the use of this therapy in patients with renal failure. In light of this valuable safety data, they proceeded with a prospective cohort study involving 40 patients on their Intensive Care Unit. Again the outcomes were favourable with a mean increase of 0.48mmol/L after administration of 20mmol in 100ml of saline over 1 hour. They reported no instances of hyperkalaemia, and data suggested a decreased instance of ectopic beats versus control patients.
The use of a variable dose regime dictated by serum potassium concentration has also been assessed. In a prospective cohort study 20, 30 or 40mmol was administered over 1 hour to 48 patients based on their initial measured potassium level. They only reported 2 instances of hyperkalaemia but neither patient experienced any complications. Usefully they found that patients with oliguric renal failure (creatinine 283 ± 127 micromol/L) had no greater mean increase in potassium level after infusion than patients with normal creatinine clearance.
Two other methods have been suggested. The first, assessed on a paediatric intensive care unit, administered potassium at a rate of 0.25mmol/kg/hr to patients with serum potassium < 3.5mmol/L and ECG abnormalities. The infusion was continued until the ECG abnormalities were corrected. Serum potassium wasn't measured until after completing the infusion, and although the mean increase was only 0.75mmol/L, this method did expose patients to a risk of unmonitored hyperkalaemia. The other involves use of a feedback system with a computer-algorithm driven protocol. This method was not developed into a full production model due to lack of cost-effectiveness.
We were unable to find any trials assessing the efficacy and safety of continuous potassium infusions in the critical care population, so felt it was time this was rectified. Critically ill patients are often hypokalaemic due to insensible losses, inadequate supplementation prior to admission, and use of diuretics and beta-agonists. At the same time they often have acute and/or chronic renal failure or may have a metabolic acidosis that will hamper normal potassium sequestration or excretion. Thus they are at risk of rapidly developing life-threatening hyperkalaemia if supplementation is not carefully titrated against serial monitoring. Continuous infusions administered with due vigilance should allow for correction of hypokalaemia in a safe and precise manner.
Our department used to supplement potassium by intermittent infusion, but after internal discussion we have successfully implemented a continuous infusion protocol. We propose that continuous infusions administered by accredited nurses under physician direction can safely deliver potassium and correct abnormal levels.
- Conditions
- Hypokalemia, Arrhythmias, Cardiac
- Being tested
- Sterile Potassium Chloride Concentrate
- Keywords
- Potassium chloride, Preparations, Pharmaceutical, Hypokalemia, Critical Care, Adult, Randomized Controlled Trial
- Medical subject headings
- Hypokalemia, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterile Potassium Chloride ConcentrateDrug
Also called CAS no: 7447-40-7
Continuous infusion, 40mmol in 40ml, starting at 10ml/hr, rate altered according to serum potassium level checked 2 hourly
Sterile Potassium Chloride ConcentrateDrug
Also called CAS no: 7447-40-7
By intermittent infusion, 20mmol diluted in 100ml 0.9% NaCl, administered over 60 mins, serum potassium level checked 2 hourly, and repeat doses administered as appropriate
| Study group | Role | What they receive |
|---|---|---|
| Continuous | Experimental | This group will receive potassium chloride by continuous infusion on a sliding-scale system based on serum potassium level. Receives: Drug: Sterile Potassium Chloride Concentrate |
| Intermittent | Active comparator | This arm will form the control group and receive potassium chloride by intermittent infusion as per conventional management Receives: Drug: Sterile Potassium Chloride Concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to a potassium level 4.0 - 4.5mmol/L
Measured: 7 days
Secondary outcomes (4)
Total quantity of potassium administered
Measured: 7 days
Incidence of potassium level < 3.0mmol/L and > 5.5mmol/L
Measured: 7 days
Incidence of arrhythmia
Measured: 7 days
Number of arterial blood gases taken
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2008 (estimated)
- Study startOct 2008
- Primary completionSep 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypokalemiaStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Queen Elizabeth Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Richard Chalwin, FCICM, Principal investigator, The Queen Elizabeth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00718068
- Sponsor's protocol ID
- 2007185
- Acronym
- ASPIC
- Status last verified
- Nov 2009
- First submitted
- 16 Jul 2008
- Last updated
- 27 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Safety of a Continuous Potassium Chloride Infusion in Critical Care: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00718068
- Acronym / sponsor ID
- ASPIC / 2007185
- Conditions
- Hypokalemia, Arrhythmias, Cardiac
- Keywords
- Potassium chloride, Preparations, Pharmaceutical, Hypokalemia, Critical Care, Adult, Randomized Controlled Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- The Queen Elizabeth HospitalUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 18 Jul 2008 (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.
Patients in critical care often require supplemental potassium chloride if levels in their blood are below acceptable level. Common practice is to administer a single dose of potassium chloride under controlled conditions via a drip, before checking if a further dose is required. The purpose of this study is to ensure that it is safe to administer potassium chloride continuously with the dose varied according to patient needs.
Detailed description
The use of potassium supplementation is commonplace in the critical care environment. Patients often have abnormal serum potassium levels due to active disease processes. Conditions such as acute renal failure and metabolic acidosis precipitate hyperkalaemia, with ileus and insensible losses causing hypokalaemia. Both hypo- and hyperkalaemia can cause life-threatening arrythmias so it is prudent to rectify aberrant levels.
The standard treatment of hypokalaemia in intensive care units is by intravenous administration of potassium chloride. This can be given either as a dilute solution as maintenance intravenous fluid therapy, or as a concentrated solution by intermittent infusion. Alternatively potassium can be given as a concentrated solution by continuous infusion. All techniques require regular monitoring of the patient's serum potassium level with appropriate alterations to the administration regime.
From a theoretical standpoint it would make sense to give potassium by continuous infusion as this allow slow but steady correction of hypokalaemia. A continuous infusion should prevent rapid fluctuations in the serum level that could be caused by intermittent infusions, which may precipitate arrhythmia. However continuous infusions require vigilant monitoring to ensure that hyperkalaemia does not occur and must be given into a central vein to avoid the risk of phlebitis.
The use of intermittent infusions has been used safely in the critical care setting under physician guidance. A retrospective review reported the outcomes of the administration of 495 infusion sets to 190 individuals. While they identified 2 instances of post-infusion hyperkalaemia, neither was associated with any adverse sequelae. Analysis showed a no correlation between serum potassium increase post-infusion and serum creatinine, thus advocating the use of this therapy in patients with renal failure. In light of this valuable safety data, they proceeded with a prospective cohort study involving 40 patients on their Intensive Care Unit. Again the outcomes were favourable with a mean increase of 0.48mmol/L after administration of 20mmol in 100ml of saline over 1 hour. They reported no instances of hyperkalaemia, and data suggested a decreased instance of ectopic beats versus control patients.
The use of a variable dose regime dictated by serum potassium concentration has also been assessed. In a prospective cohort study 20, 30 or 40mmol was administered over 1 hour to 48 patients based on their initial measured potassium level. They only reported 2 instances of hyperkalaemia but neither patient experienced any complications. Usefully they found that patients with oliguric renal failure (creatinine 283 ± 127 micromol/L) had no greater mean increase in potassium level after infusion than patients with normal creatinine clearance.
Two other methods have been suggested. The first, assessed on a paediatric intensive care unit, administered potassium at a rate of 0.25mmol/kg/hr to patients with serum potassium < 3.5mmol/L and ECG abnormalities. The infusion was continued until the ECG abnormalities were corrected. Serum potassium wasn't measured until after completing the infusion, and although the mean increase was only 0.75mmol/L, this method did expose patients to a risk of unmonitored hyperkalaemia. The other involves use of a feedback system with a computer-algorithm driven protocol. This method was not developed into a full production model due to lack of cost-effectiveness.
We were unable to find any trials assessing the efficacy and safety of continuous potassium infusions in the critical care population, so felt it was time this was rectified. Critically ill patients are often hypokalaemic due to insensible losses, inadequate supplementation prior to admission, and use of diuretics and beta-agonists. At the same time they often have acute and/or chronic renal failure or may have a metabolic acidosis that will hamper normal potassium sequestration or excretion. Thus they are at risk of rapidly developing life-threatening hyperkalaemia if supplementation is not carefully titrated against serial monitoring. Continuous infusions administered with due vigilance should allow for correction of hypokalaemia in a safe and precise manner.
Our department used to supplement potassium by intermittent infusion, but after internal discussion we have successfully implemented a continuous infusion protocol. We propose that continuous infusions administered by accredited nurses under physician direction can safely deliver potassium and correct abnormal levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous | Experimental | Drug: Sterile Potassium Chloride ConcentrateThis group will receive potassium chloride by continuous infusion on a sliding-scale system based on serum potassium level. |
| Intermittent | Active comparator | Drug: Sterile Potassium Chloride ConcentrateThis arm will form the control group and receive potassium chloride by intermittent infusion as per conventional management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any inpatient on the investigating unit with a serum potassium level of less than 3.8mmol/L
- arterial line for blood sampling and central venous access for infusion administration in situ
- continuous 12-lead ECG monitoring
Key exclusion criteria (4 listed)
- Patients with a serum potassium ≥ 3.8mmol/L
- Renal dysfunction with serum creatinine 50% greater than the upper end of the normal reference range (i.e.: > 180micromol/L) or urine output less than 0.5ml/kg/hr for 6 consecutive hours, or the requirement for dialysis
- Burns
- Hypomagnesaemia (≤ 0.7mmol/L), however patients may be enrolled after the hypomagnesaemia is corrected
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 |
|---|---|---|
| Sterile Potassium Chloride ConcentrateAlso: CAS no: 7447-40-7Continuous infusion, 40mmol in 40ml, starting at 10ml/hr, rate altered according to serum potassium level checked 2 hourly | Drug | Continuous |
| Sterile Potassium Chloride ConcentrateAlso: CAS no: 7447-40-7By intermittent infusion, 20mmol diluted in 100ml 0.9% NaCl, administered over 60 mins, serum potassium level checked 2 hourly, and repeat doses administered as appropriate | Drug | Intermittent |
Primary outcome
Adherence to a potassium level 4.0 - 4.5mmol/L
Time frame: 7 days
4 secondary outcomes
Total quantity of potassium administered
Time frame: 7 days
Incidence of potassium level < 3.0mmol/L and > 5.5mmol/L
Time frame: 7 days
Incidence of arrhythmia
Time frame: 7 days
Number of arterial blood gases taken
Time frame: 7 days
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 27 Jul 2010.
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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.
Richard Chalwin, FCICM principal investigator
The Queen Elizabeth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sterile Potassium Chloride Concentrate in people with Hypokalemia and Arrhythmias, Cardiac, run by The Queen Elizabeth Hospital at 1 site in Australia.
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 3 inclusion and 4 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 27 Jul 2010. 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 Australia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Adherence to a potassium level 4.0 - 4.5mmol/L (time frame: 7 days). 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 27 Jul 2010.