Efficacy of KCl Plus 0.9%NaCl Compare With KCl Plus 0.45%NaCl

Hypokalemia Clinical Trial

Official title:

Efficacy of KCl Plus 0.9%NaCl Compare With KCl Plus 0.45%NaCl for Correction of Hypokalemia in Hospitalized Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02721095
• Other study ID #: PMK1981
• Status: Recruiting
• Phase: Phase 4
• First received: May 25, 2015
• Last updated: May 1, 2016
• Start date: August 2014
• Est. completion date: September 2016

Study information

• Verified date: May 2016
• Source: Phramongkutklao College of Medicine and Hospital
• Contact: Theerasak Tangwonglert, MD.
• Phone: 0897750222
• Email: theerasak.pmk[@]gmail.com
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypokalemia

Intervention

Other:
• KCl plus 0.9%NaCl
comparison of KCl plus 0.9%NaCl and KCl plus 0.45%NaCl for correction of hypokalemia
• KCl plus 0.45%NaCl
comparison of KCl plus 0.9%NaCl and KCl plus 0.45%NaCl for correction of hypokalemia

Locations

Country	Name	City	State
Thailand	Phramonkutklao Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Phramongkutklao College of Medicine and Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with normal serum K as assessed by serum electrolyte		24 hours	Yes