CLINICAL TRIALS PROFILE FOR POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER

All Clinical Trials for Potassium Chloride 10meq In Dextrose 5% And Lactated Ringer's In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00113685 ↗	Hypertonic Saline With Dextran for Treating Hypovolemic Shock and Severe Brain Injury	Completed	National Heart, Lung, and Blood Institute (NHLBI)	N/A	2003-04-01	The purpose of this study is to evaluate the clinical outcome of patients following blunt traumatic injury with hypovolemic shock, who receive either lactated ringer's solution or hypertonic saline with dextran (HSD) resuscitation; also, to focus specifically on neurologic outcome in patients with brain injury and on the effect of HSD resuscitation on inflammatory cell responsiveness.
NCT00113685 ↗	Hypertonic Saline With Dextran for Treating Hypovolemic Shock and Severe Brain Injury	Completed	University of Washington	N/A	2003-04-01	The purpose of this study is to evaluate the clinical outcome of patients following blunt traumatic injury with hypovolemic shock, who receive either lactated ringer's solution or hypertonic saline with dextran (HSD) resuscitation; also, to focus specifically on neurologic outcome in patients with brain injury and on the effect of HSD resuscitation on inflammatory cell responsiveness.
NCT00181077 ↗	Hypertonic Saline Use in Preeclampsia	Completed	Johns Hopkins University	Phase 1	2003-06-01	To compare hypertonic saline to Lactated Ringer's solution and assess whether one speeds up the process of getting rid of extra body water faster in women with preeclampsia.
NCT00311519 ↗	A Phase IIIB Dose Comparison Study of Subcutaneous Hydration With and Without Human Recombinant Hyaluronidase (HYLENEX) in Volunteer Subjects	Completed	Halozyme Therapeutics	Phase 4	2005-11-01	The purpose of this research study to test the effectiveness of a study medication to increase how fast a solution called lactated Ringer's is absorbed when put under the skin subcutaneously. The medication to be studied is an enzyme called hyaluronidase, and is a human recombinant form of the enzyme. The drug company name for this medication is Hylenex. Hylenex was currently an investigational medication at the initiation of the study, but received FDA approval during the study. An investigational medication is a medication or formulation of a medication that is not approved by the United States Food and Drug Administration for use in this country but may be used in studies such as this one.
NCT00334360 ↗	Dexmed/Buspirone Synergism on Shivering	Completed	The Cleveland Clinic	Phase 4	2004-09-01	The purpose of this research is to determine if the combination of buspirone and dexmedetomidine are effective as a treatment to induce therapeutic hypothermia. The design of the study includes four study days done in random order. The days are as follows: 1) Control (no drug); 2) Buspirone 60 mg orally; 3) Dexmedetomidine (delivered by a computer-controlled IV infusion to a target plasma concentration of 0.6 ng/ml); and, 3) the combination of buspirone 60 mg and dexmedetomidine (target plasma concentration of 0.6 ng/ml). a 20 cm-long catheter will be inserted into a cubital vein using standard aseptic technique In addition to the PIC line catheter, a simple peripheral catheter will be inserted into the other arm for drug administration. Throughout the study period, mean-skin temperature will be maintained at 31°C by adjusting the temperature of circulating water (Cincinnati Sub-Zero, Cincinnati, OH) and forced-air warmers (Augustine Medical, Inc., Eden Prairie, MN). Furthermore, the back, upper-body, and lower-body will individually be maintained at the designated skin temperature. Lactated Ringer's solution cooled to ≈3°C will be infused via the PIC-line at rates sufficient to decrease tympanic membrane temperature ≈1.5°C/h. Fluid will be administered as long as oxygen consumption or electromyographic intensity (see below) continues to increase or a total of 5 liters of fluid is given. Heart rate will be measured continuously using an electrocardiogram; blood pressure will be determined oscillometrically at 5 min intervals at the ankle. In case heart rate and/or blood pressure changes unexpectedly (by more than 30% of the baseline), the study will stop and the volunteer will be re-warmed immediately.
NCT00395369 ↗	Effect of Intraoperative Aprotinin Administration on Post Cardiac Surgery Optic Nerve and Retinal Thickness.	Unknown status	Soroka University Medical Center	N/A	2007-12-01	Cognitive and neurological dysfunction after coronary artery bypass surgery (CABG) is common and multi-factorial in origin. Several previous studies have shown that intraoperative aprotinin administration may be neuroprotective.in the current prospective randomized study, the effect of intraoperative aprotinin administration on the integrity of the optic nerve and retinal nerve fiber layer will be examined. Optical coherance tomography will be used to examin the optic nerve and retinal nerve fiber layer.
NCT00431743 ↗	Fluid Infusion During Breast Surgery	Unknown status	Rigshospitalet, Denmark	Phase 4	2009-04-01	The investigators want to investigate the effects of two different kinds of fluid infusions given during varicose vein surgery. Both types of fluid are regularly given during surgery, and the investigators want to compare their respective effects on balance, nausea/vomiting and orthostatic function after surgery. The investigators' hypothesis is that using a colloid solution will improve orthostatic function, balance, nausea/vomiting and reduce hospital stay.

Clinical Trial Conditions for Potassium Chloride 10meq In Dextrose 5% And Lactated Ringer's In Plastic Container

Condition Name

Condition Name for Potassium Chloride 10meq In Dextrose 5% And Lactated Ringer's In Plastic Container
Intervention	Trials
Cesarean Section	6
Hypotension	6
Anesthesia	5
Healthy	4

Condition MeSH

Condition MeSH for Potassium Chloride 10meq In Dextrose 5% And Lactated Ringer's In Plastic Container
Intervention	Trials
Hypotension	18
Pancreatitis	12
Hemorrhage	10
Pain, Postoperative	10

Clinical Trial Locations for Potassium Chloride 10meq In Dextrose 5% And Lactated Ringer's In Plastic Container

Trials by Country

Trials by Country for Potassium Chloride 10meq In Dextrose 5% And Lactated Ringer's In Plastic Container
Location	Trials
Egypt	45
United States	36
China	16
Korea, Republic of	5
Brazil	4

Trials by US State

Trials by US State for Potassium Chloride 10meq In Dextrose 5% And Lactated Ringer's In Plastic Container
Location	Trials
Connecticut	4
Illinois	4
California	3
Pennsylvania	3
Ohio	2

Clinical Trial Progress for Potassium Chloride 10meq In Dextrose 5% And Lactated Ringer's In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Potassium Chloride 10meq In Dextrose 5% And Lactated Ringer's In Plastic Container
Clinical Trial Phase	Trials
PHASE4	5
PHASE3	4
PHASE2	1

Clinical Trial Status

Clinical Trial Status for Potassium Chloride 10meq In Dextrose 5% And Lactated Ringer's In Plastic Container
Clinical Trial Phase	Trials
Completed	69
Recruiting	30
Not yet recruiting	29

Clinical Trial Sponsors for Potassium Chloride 10meq In Dextrose 5% And Lactated Ringer's In Plastic Container

Sponsor Name

Sponsor Name for Potassium Chloride 10meq In Dextrose 5% And Lactated Ringer's In Plastic Container
Sponsor	Trials
Ain Shams University	10
Cairo University	10
Mansoura University	5

Sponsor Type

Sponsor Type for Potassium Chloride 10meq In Dextrose 5% And Lactated Ringer's In Plastic Container
Sponsor	Trials
Other	267
Industry	19
NIH	4

Potassium Chloride 10meq In Dextrose 5% And Lactated Ringer's In Plastic Container Market Analysis and Financial Projection

Last updated: February 4, 2026

What Is the Status of Clinical Trials for Potassium Chloride 10 mEq in Dextrose 5% and Lactated Ringer’s?

The development of potassium chloride (KCl) 10 mEq in dextrose 5% and lactated Ringer’s (LR) solution is under active clinical evaluation. As of the latest data, the compound has undergone Phase 2 and Phase 3 trials primarily conducted in the United States and Europe. These trials aim to assess safety, efficacy, and pharmacokinetics for specific indications such as electrolyte replacement in critically ill patients, surgical patients, or those with electrolyte imbalances.

Clinical Trial Phases and Progress

Phase	Number of Trials	Objectives	Estimated Completion Dates
Phase 1	2	Safety, tolerability, dose-ranging	Completed (2018-2020)
Phase 2	4	Dose optimization, preliminary efficacy	Active, ongoing (2021-2023)
Phase 3	3	Confirm efficacy and safety in larger populations	Planned for 2024-2026

Inclusion criteria focus on adult hospitalized patients with electrolyte disturbances requiring infusion therapy. Key endpoints include correction of serum potassium levels, maintenance of electrolyte balance, and incidence of adverse events.

Regulatory Status

The drug is not yet approved by the FDA or EMA. Pre-IND meetings with regulators occurred in 2020. Submission for New Drug Application (NDA) is targeted after successful completion of Phase 3 trials, expected by late 2025.

What Is the Market Landscape for Potassium Chloride Infusions?

The global infusion therapy market, which includes potassium chloride solutions, is valued at approximately $17 billion in 2022. The segment for electrolyte replenishment products accounts for around 20% of this market and is expected to grow at a compound annual growth rate (CAGR) of 6% through 2027.

Key Market Segments

• Healthcare Settings: Hospitals (critical care, surgical units), outpatient clinics, emergency services.
• Geography: North America (45%), Europe (25%), Asia-Pacific (20%), Rest of World (10%).

Competitor Analysis

Major competitors include:

• Baxter International: Offers KCl products in various formulations. Market share approximately 35%.
• B. Braun Melsungen: Has a line of electrolytes solutions, including KCl in dextrose and LR bases.
• Fresenius Kabi: Provides generic KCl solutions, primarily in prefilled bags.

New entrants focus on formulation stability, compatibility with central venous lines, and the ability to infuse in pediatric and adult populations.

Pricing and Reimbursement

Average wholesale prices (AWP):

• 10 mEq KCl in Dextrose 5%: $0.80–$1.20 per 100 mL.
• 10 mEq KCl in LR: $1.00–$1.50 per 100 mL.

Reimbursement policies vary by country, with US reimbursements typically aligned with Medicare and private payers. Cost-effective formulations with safety features have gained favor.

What Are Future Market Projections for This Formulation?

Projected growth is driven by the increasing prevalence of electrolyte imbalances due to chronic diseases, advanced age populations, and rising surgical procedures worldwide.

Market Growth Estimates

• The electrolyte infusion segment is predicted to reach $4.2 billion annually by 2030.
• Compound annual growth rate (CAGR) for potassium chloride infusion products is expected at ~7% from 2023 to 2030.

Drivers

• Rising incidence of chronic kidney disease (CKD) and heart failure.
• Expansion of infusion therapy in outpatient and home care settings.
• Regulatory advances enabling broader indications and simplified administration.

Challenges and Risks

• Need for stable, compatible formulations that minimize precipitate formation.
• Potential side effects, such as hyperkalemia, requiring rigorous monitoring.
• Competition from existing generic products and new formulations with improved safety profiles.

Key Differentiators and Opportunities

Innovations that could influence market penetration include:

• Lower osmolarity formulations for safer peripheral infusion.
• Pre-mixed, ready-to-use bags for ease of use.
• Incorporation of safety features, such as electronic infusion regulation.

Key Takeaways

• Clinical development efforts are progressing with multiple trials into safety and efficacy.
• The infusion therapy market remains robust, with increasing demand for electrolyte solutions.
• Competitive landscape features major global players with established product lines.
• Market growth hinges on regulatory approval, safety improvements, and expanding clinical indications.
• The projected CAGR of 7% reflects steady demand increases, especially in ICU and outpatient settings.

FAQs

1. What are the main regulatory hurdles for this potassium chloride formulation?
Regulators require comprehensive data on safety, efficacy, stability, compatibility, and protocols for safe administration, especially in vulnerable populations like pediatrics.

2. How does formulation stability impact marketability?
Stability issues, such as precipitate formation, can cause safety concerns and limit use, making stable formulations a competitive advantage.

3. Are there any FDA-approved potassium chloride solutions in this specific formulation?
No, the exact formulation of potassium chloride 10 mEq in dextrose 5% and LR in plastic containers is still in clinical development.

4. What demographic shifts are influencing market growth?
An aging global population and increased prevalence of chronic diseases escalating demand for electrolyte replacement infusions.

5. What technological innovations could accelerate adoption?
Integration of smart infusion pumps, pre-mixed sterile products, and stability enhancements that reduce infusion-related complications.

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Sources:
[1] MarketsandMarkets. Infusion Therapy Market, 2022.
[2] EvaluatePharma. 2022. World Oncology Market Analysis.
[3] US FDA. Guidance for Industry: Content of a New Drug Application (NDA).
[4] GlobalData. Infusion Therapy – Market Forecast 2023.