Efficacy of KCl Plus 0.9%NaCl Compare With KCl Plus 0.45%... | NCT02721095

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

NCT02721095

Sponsor

Phramongkutklao College of Medicine and Hospital

Status

Unknown status

Last Update Posted

May 3, 2016Estimated

Enrollment

84Estimated

Phase

Phase 4

Conditions

Hypokalemia

Interventions

KCl plus 0.9%NaCl
KCl plus 0.45%NaCl

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Jul 2016Estimated

Completion Date

Sep 2016Estimated

First Submitted Date

May 25, 2015

First Submission Date that Met QC Criteria

Mar 22, 2016

First Posted Date

Mar 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2016

Last Update Posted Date

May 3, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

84Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
0.9%NaCl	Experimental	KCl plus 0.9%NaCl	Other: KCl plus 0.9%NaCl
0.45%NaCl	Active Comparator	KCl plus 0.45%NaCl	Other: KCl plus 0.45%NaCl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KCl plus 0.9%NaCl	Other	comparison of KCl plus 0.9%NaCl and KCl plus 0.45%NaCl for correction of hypokalemia	0.9%NaCl

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with normal serum K as assessed by serum electrolyte		24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Theerasak Tangwonglert, MD.	Contact	0897750222		theerasak.pmk@gmail.com

Overall Officials

Name	Affiliation	Role
Yaowana Thanapat, MD	Instituitional review board royal thai army medical department	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Phramonkutklao Hospital	Recruiting	Bangkok		10400	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D007008	Hypokalemia

Ancestor Terms

ID	Term
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided