HypokalemiaPhase 4NCT02721095
Efficacy of KCl Plus 0.9%NaCl Compare With KCl Plus 0.45%NaCl
A Phase 4 study testing KCl plus 0.9%NaCl and KCl plus 0.45%NaCl in people with Hypokalemia, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
Trial summary
evaluate efficacy and safety of IV administration of potassium chloride (KCl) plus 0.9%NaCl compare with KCl plus half-strength normal saline solution (0.45%NaCl) in correcting hypokalemia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypokalemia
- What is being tested?
- KCl plus 0.9%NaCl and KCl plus 0.45%NaCl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2014to Sep 2016
- 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
- Serum K+ 2.5-3.49 mmol/L
- No life threatening condition from hypokalemia
Who cannot join
- Pregnancy
- Volume overload, heart failure
- Hypotension
- Acute kidney injury
- Dysnatremia
- K+ shift
- Salt wasting nephropathy
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Phramonkutklao Hospital
Bangkok, 10400
Theerasak Tangwonglert, MD., 0897750222, theerasak.pmk@gmail.com
Theerasak - Tangwonglert, MD.
About this study
Official title: Efficacy of KCl Plus 0.9%NaCl Compare With KCl Plus 0.45%NaCl for Correction of Hypokalemia in Hospitalized Patients
evaluate efficacy and safety of IV administration of potassium chloride (KCl) plus 0.9%NaCl compare with KCl plus half-strength normal saline solution (0.45%NaCl) in correcting hypokalemia
Read the detailed description
Hypokalemia is frequently encountered in hospitalized patients. Intravenous (IV) potassium repletion with saline is preferred used for initial therapy. However, administration of normal saline (0.9%NaCl) usually provokes sodium and potassium diuresis, thus, it might delay reversal of the hypokalemia.
Object of this study : to evaluate efficacy and safety of IV administration of potassium chloride (KCl) plus 0.9%NaCl compare with KCl plus half-strength normal saline solution (0.45%NaCl) in correcting hypokalemia.
- Conditions
- Hypokalemia
- Being tested
- KCl plus 0.9%NaCl, KCl plus 0.45%NaCl
- Medical subject headings
- Hypokalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KCl plus 0.9%NaClOther
comparison of KCl plus 0.9%NaCl and KCl plus 0.45%NaCl for correction of hypokalemia
KCl plus 0.45%NaClOther
comparison of KCl plus 0.9%NaCl and KCl plus 0.45%NaCl for correction of hypokalemia
| Study group | Role | What they receive |
|---|---|---|
| 0.9%NaCl | Experimental | KCl plus 0.9%NaCl Receives: Other: KCl plus 0.9%NaCl |
| 0.45%NaCl | Active comparator | KCl plus 0.45%NaCl Receives: Other: KCl plus 0.45%NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with normal serum K as assessed by serum electrolyte
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2016 (estimated)
- Study startAug 2014
- Primary completionJul 2016 (estimated)
- Study completionSep 2016 (estimated)
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
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phramongkutklao College of Medicine and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yaowana Thanapat, MD, Principal investigator, Instituitional review board royal thai army medical department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721095
- Sponsor's protocol ID
- PMK1981
- Status last verified
- May 2016
- First submitted
- 25 May 2015
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of KCl Plus 0.9%NaCl Compare With KCl Plus 0.45%NaCl for Correction of Hypokalemia in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT02721095
- Acronym / sponsor ID
- PMK1981
- Conditions
- Hypokalemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Phramongkutklao College of Medicine and HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 28 Mar 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.
evaluate efficacy and safety of IV administration of potassium chloride (KCl) plus 0.9%NaCl compare with KCl plus half-strength normal saline solution (0.45%NaCl) in correcting hypokalemia
Detailed description
Hypokalemia is frequently encountered in hospitalized patients. Intravenous (IV) potassium repletion with saline is preferred used for initial therapy. However, administration of normal saline (0.9%NaCl) usually provokes sodium and potassium diuresis, thus, it might delay reversal of the hypokalemia.
Object of this study : to evaluate efficacy and safety of IV administration of potassium chloride (KCl) plus 0.9%NaCl compare with KCl plus half-strength normal saline solution (0.45%NaCl) in correcting hypokalemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.9%NaCl | Experimental | Other: KCl plus 0.9%NaClKCl plus 0.9%NaCl |
| 0.45%NaCl | Active comparator | Other: KCl plus 0.45%NaClKCl plus 0.45%NaCl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Serum K+ 2.5-3.49 mmol/L
- No life threatening condition from hypokalemia
Key exclusion criteria (7 listed)
- Pregnancy
- Volume overload, heart failure
- Hypotension
- Acute kidney injury
- Dysnatremia
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 |
|---|---|---|
| KCl plus 0.9%NaClcomparison of KCl plus 0.9%NaCl and KCl plus 0.45%NaCl for correction of hypokalemia | Other | 0.9%NaCl |
| KCl plus 0.45%NaClcomparison of KCl plus 0.9%NaCl and KCl plus 0.45%NaCl for correction of hypokalemia | Other | 0.45%NaCl |
Primary outcome
Number of participants with normal serum K as assessed by serum electrolyte
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
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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.
Yaowana Thanapat, MD principal investigator
Instituitional review board royal thai army medical department
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 KCl plus 0.9%NaCl and KCl plus 0.45%NaCl in people with Hypokalemia, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 May 2016. 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Theerasak Tangwonglert, MD. (0897750222, theerasak.pmk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with normal serum K as assessed by serum electrolyte (time frame: 24 hours). 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 3 May 2016.