The Impact of Neut During Potassium Chloride Replacement on Pain and Incidence of Phlebitis

NCT02082717 | Terminated Phase 4 Results

• 1 other identifier: IRB # 13-060
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the impact of 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy for adult patients in a Medical/Surgical unit. Using a randomized controlled double blinded experimental study design, patients who are 21 years or older are alert, awake, and oriented at the time of enrollment and have been ordered peripheral intravenous potassium chloride replacement will be recruited from one Medical/Surgical during the first 24-48 hours of their admission.

Conditions

Hypokalemia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Indicated Findings

  outcomes - phlebitis, pain at peripheral intravenous insertion site, frequency of changing IV access, and time for administration. experimental - 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy. control - standard of practice of no 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy.

  Up to 4 hours

Secondary Outcomes (2)

• Number of Participants Nursing Interventions

  Up to 4 hours

• Attrition Rates

  Up to 4 hours

Study Arms (2)

Neut (4%sodium bicarbonate additive)

EXPERIMENTAL

4% sodium bicarbonate additive during intravenous potassium chloride replacement.

Drug: potassium chloride replacement; Drug: Experimental - 4% Sodium Bicarbonate

Control

ACTIVE COMPARATOR

standard of practice potassium chloride replacement (with no additive)

Drug: potassium chloride replacement

Interventions

potassium chloride replacement DRUG

Control; Neut (4%sodium bicarbonate additive)

Experimental - 4% Sodium Bicarbonate DRUG

Neut (4%sodium bicarbonate additive)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• admitted to the medical/surgical unit within the last 24 to 48 hours
• awake, alert, and oriented times three
• years old and greater
• receiving first peripheral intravenous potassium chloride replacement therapy as ordered by physician or ARNP as part of care and regardless of research
• potassium level of 3.5 mmol/L or less.

You may not qualify if:

• patients who have been in the medical/surgical unit more than 48 hours.
• altered mental status defined as not being awake, alert, and oriented times three
• patients who already received intravenous potassium chloride replacement during the current admission and with the current IV access
• patients receiving intravenous potassium replacement therapy through a central line
• patients that are not ordered potassium replacement by physician or ARNP as part of their care while hospitalized.

Sponsors & Collaborators

• Baptist Health South Florida: lead

Study Sites (1)

West Kendall Baptist Hospital

Miami, Florida, 33196, United States

Location

MeSH Terms

Conditions

Hypokalemia

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Diana D'Orazio-Garcia
• Organization: Baptist Health South Florida

DianaDO@baptisthealth.net

786-594-9737

Study Officials

• Mavel Arinal, RN

  BHSF

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: March 10, 2014
• Study Start: February 25, 2014
• Primary Completion: August 3, 2018
• Study Completion: August 3, 2018
• Last Updated: April 1, 2021
• Results First Posted: April 1, 2021

Record last verified: 2021-03

Locations

US (1)