NCT02721095

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2015

Completed
10 months until next milestone

First Posted

Study publicly available on registry

March 28, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

May 3, 2016

Status Verified

May 1, 2016

Enrollment Period

1.9 years

First QC Date

May 25, 2015

Last Update Submit

May 1, 2016

Conditions

Hypokalemia

Outcome Measures

Primary Outcomes (1)

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

    24 hours

Study Arms (2)

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

KCl plus 0.9%NaClOTHER

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

0.9%NaCl
KCl plus 0.45%NaClOTHER

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

0.45%NaCl

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Serum K+ 2.5-3.49 mmol/L
  • No life threatening condition from hypokalemia

You may not qualify if:

  • Pregnancy
  • Volume overload, heart failure
  • Hypotension
  • Acute kidney injury
  • Dysnatremia
  • K+ shift
  • Salt wasting nephropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phramonkutklao Hospital

Bangkok, 10400, Thailand

RECRUITING

MeSH Terms

Conditions

Hypokalemia

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Yaowana Thanapat, MD

    Instituitional review board royal thai army medical department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Theerasak Tangwonglert, MD.

CONTACT

0897750222theerasak.pmk@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2015

First Posted

March 28, 2016

Study Start

August 1, 2014

Primary Completion

July 1, 2016

Study Completion

September 1, 2016

Last Updated

May 3, 2016

Record last verified: 2016-05

Locations

TH(1)