- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02721095
Efficacy of KCl Plus 0.9%NaCl Compare With KCl Plus 0.45%NaCl
Efficacy of KCl Plus 0.9%NaCl Compare With KCl Plus 0.45%NaCl for Correction of Hypokalemia in Hospitalized Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Theerasak Tangwonglert, MD.
- Phone Number: 0897750222
- Email: theerasak.pmk@gmail.com
Study Locations
-
-
-
Bangkok, Thailand, 10400
- Recruiting
- Phramonkutklao Hospital
-
Contact:
- Theerasak Tangwonglert, MD.
- Phone Number: 0897750222
- Email: theerasak.pmk@gmail.com
-
Principal Investigator:
- Theerasak - Tangwonglert, MD.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Serum K+ 2.5-3.49 mmol/L
- No life threatening condition from hypokalemia
Exclusion Criteria:
- Pregnancy
- Volume overload, heart failure
- Hypotension
- Acute kidney injury
- Dysnatremia
- K+ shift
- Salt wasting nephropathy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 0.9%NaCl
KCl plus 0.9%NaCl
|
comparison of KCl plus 0.9%NaCl and KCl plus 0.45%NaCl for correction of hypokalemia
|
Active Comparator: 0.45%NaCl
KCl plus 0.45%NaCl
|
comparison of KCl plus 0.9%NaCl and KCl plus 0.45%NaCl for correction of hypokalemia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with normal serum K as assessed by serum electrolyte
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yaowana Thanapat, MD, Instituitional review board royal thai army medical department
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PMK1981
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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