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

NCT ID: NCT02721095

Last Updated: 2016-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-09-30

Brief Summary

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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

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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

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Hypokalemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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0.9%NaCl

KCl plus 0.9%NaCl

Group Type EXPERIMENTAL

KCl plus 0.9%NaCl

Intervention Type OTHER

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

0.45%NaCl

KCl plus 0.45%NaCl

Group Type ACTIVE_COMPARATOR

KCl plus 0.45%NaCl

Intervention Type OTHER

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

Interventions

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KCl plus 0.9%NaCl

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

Intervention Type OTHER

KCl plus 0.45%NaCl

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Phramongkutklao College of Medicine and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yaowana Thanapat, MD

Role: PRINCIPAL_INVESTIGATOR

Instituitional review board royal thai army medical department

Locations

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Phramonkutklao Hospital

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Theerasak Tangwonglert, MD.

Role: CONTACT

0897750222

Facility Contacts

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Theerasak Tangwonglert, MD.

Role: primary

0897750222

Other Identifiers

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PMK1981

Identifier Type: -

Identifier Source: org_study_id

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