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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Australia

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.

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 groups in NCT00718068
Study groupRoleWhat they receive
ContinuousExperimentalThis group will receive potassium chloride by continuous infusion on a sliding-scale system based on serum potassium level.
Receives: Drug: Sterile Potassium Chloride Concentrate
IntermittentActive comparatorThis 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.

  1. Adherence to a potassium level 4.0 - 4.5mmol/L

    Measured: 7 days

Secondary outcomes (4)
  1. Total quantity of potassium administered

    Measured: 7 days

  2. Incidence of potassium level < 3.0mmol/L and > 5.5mmol/L

    Measured: 7 days

  3. Incidence of arrhythmia

    Measured: 7 days

  4. 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.

  1. First posted18 Jul 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionSep 2009
  4. Study completionOct 2009

Resources

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)
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

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.

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