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

Primary Purpose

Hypokalemia

Status
Unknown status
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
KCl plus 0.9%NaCl
KCl plus 0.45%NaCl
Sponsored by
Phramongkutklao College of Medicine and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypokalemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Phramonkutklao HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

0.9%NaCl

0.45%NaCl

Arm Description

KCl plus 0.9%NaCl

KCl plus 0.45%NaCl

Outcomes

Primary Outcome Measures

Number of participants with normal serum K as assessed by serum electrolyte

Secondary Outcome Measures

Full Information

First Posted
May 25, 2015
Last Updated
May 1, 2016
Sponsor
Phramongkutklao College of Medicine and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02721095
Brief Title
Efficacy of KCl Plus 0.9%NaCl Compare With KCl Plus 0.45%NaCl
Official Title
Efficacy of KCl Plus 0.9%NaCl Compare With KCl Plus 0.45%NaCl for Correction of Hypokalemia in Hospitalized Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Phramongkutklao College of Medicine and Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypokalemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
0.9%NaCl
Arm Type
Experimental
Arm Description
KCl plus 0.9%NaCl
Arm Title
0.45%NaCl
Arm Type
Active Comparator
Arm Description
KCl plus 0.45%NaCl
Intervention Type
Other
Intervention Name(s)
KCl plus 0.9%NaCl
Intervention Description
comparison of KCl plus 0.9%NaCl and KCl plus 0.45%NaCl for correction of hypokalemia
Intervention Type
Other
Intervention Name(s)
KCl plus 0.45%NaCl
Intervention Description
comparison of KCl plus 0.9%NaCl and KCl plus 0.45%NaCl for correction of hypokalemia
Primary Outcome Measure Information:
Title
Number of participants with normal serum K as assessed by serum electrolyte
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Theerasak Tangwonglert, MD.
Phone
0897750222
Email
theerasak.pmk@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaowana Thanapat, MD
Organizational Affiliation
Instituitional review board royal thai army medical department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phramonkutklao Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theerasak Tangwonglert, MD.
Phone
0897750222
Email
theerasak.pmk@gmail.com
First Name & Middle Initial & Last Name & Degree
Theerasak - Tangwonglert, MD.

12. IPD Sharing Statement

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

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