NCT00718068

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

July 27, 2010

Status Verified

November 1, 2009

Enrollment Period

11 months

First QC Date

July 16, 2008

Last Update Submit

July 26, 2010

Conditions

HypokalemiaArrhythmias, Cardiac

Keywords

Potassium chloridePreparations, PharmaceuticalHypokalemiaCritical CareAdultRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Adherence to a potassium level 4.0 - 4.5mmol/L

    7 days

Secondary Outcomes (4)

  • Total quantity of potassium administered

    7 days

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

    7 days

  • Incidence of arrhythmia

    7 days

  • Number of arterial blood gases taken

    7 days

Study Arms (2)

Continuous

EXPERIMENTAL

This group will receive potassium chloride by continuous infusion on a sliding-scale system based on serum potassium level.

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

Drug: Sterile Potassium Chloride Concentrate

Interventions

Sterile Potassium Chloride ConcentrateDRUG

Continuous infusion, 40mmol in 40ml, starting at 10ml/hr, rate altered according to serum potassium level checked 2 hourly

Also known as: CAS no: 7447-40-7
Continuous

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Queen Elizabeth Hospital

Woodville South, South Australia, 5011, Australia

Location

MeSH Terms

Conditions

HypokalemiaArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Richard Chalwin, FCICM

    The Queen Elizabeth Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 16, 2008

First Posted

July 18, 2008

Study Start

October 1, 2008

Primary Completion

September 1, 2009

Study Completion

October 1, 2009

Last Updated

July 27, 2010

Record last verified: 2009-11

Locations

AU(1)