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

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

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

Study Overview

• Status: Unknown
• Conditions: Hypokalemia
• Intervention / Treatment: Other: KCl plus 0.9%NaCl; Other: KCl plus 0.45%NaCl

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.

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Theerasak Tangwonglert, MD.; Phone Number: 0897750222; Email: theerasak.pmk@gmail.com

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Recruiting
    • Phramonkutklao Hospital
    • Contact: Theerasak Tangwonglert, MD.; Phone Number: 0897750222; Email: theerasak.pmk@gmail.com
    • Principal Investigator: Theerasak - Tangwonglert, MD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.9%NaCl; KCl plus 0.9%NaCl	Other: KCl plus 0.9%NaCl; comparison of KCl plus 0.9%NaCl and KCl plus 0.45%NaCl for correction of hypokalemia
Active Comparator: 0.45%NaCl; KCl plus 0.45%NaCl	Other: KCl plus 0.45%NaCl; comparison of KCl plus 0.9%NaCl and KCl plus 0.45%NaCl for correction of hypokalemia

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Phramongkutklao College of Medicine and Hospital
• Investigators: Principal Investigator: Yaowana Thanapat, MD, Instituitional review board royal thai army medical department

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): July 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: May 25, 2015
• First Submitted That Met QC Criteria: March 22, 2016
• First Posted (Estimate): March 28, 2016

Study Record Updates

• Last Update Posted (Estimate): May 3, 2016
• Last Update Submitted That Met QC Criteria: May 1, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Deficiency Diseases; Malnutrition; Water-Electrolyte Imbalance; Hypokalemia; Potassium Deficiency
• Other Study ID Numbers: PMK1981