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Last Updated: April 16, 2026

CLINICAL TRIALS PROFILE FOR DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER


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All Clinical Trials for Dextrose 2.5% In Half-strength 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Dextrose 2.5% In Half-strength Lactated Ringer's In Plastic Container

Condition Name

Condition Name for Dextrose 2.5% In Half-strength Lactated Ringer's In Plastic Container
Intervention Trials
Hypotension 6
Cesarean Section 6
Anesthesia 5
Healthy 4
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Condition MeSH

Condition MeSH for Dextrose 2.5% In Half-strength Lactated Ringer's In Plastic Container
Intervention Trials
Hypotension 18
Pancreatitis 12
Pain, Postoperative 10
Hemorrhage 10
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Clinical Trial Locations for Dextrose 2.5% In Half-strength Lactated Ringer's In Plastic Container

Trials by Country

Trials by Country for Dextrose 2.5% In Half-strength Lactated Ringer's In Plastic Container
Location Trials
Egypt 45
United States 36
China 16
Korea, Republic of 5
Italy 4
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Trials by US State

Trials by US State for Dextrose 2.5% In Half-strength Lactated Ringer's In Plastic Container
Location Trials
Connecticut 4
Illinois 4
Pennsylvania 3
California 3
Minnesota 2
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Clinical Trial Progress for Dextrose 2.5% In Half-strength Lactated Ringer's In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Dextrose 2.5% In Half-strength Lactated Ringer's In Plastic Container
Clinical Trial Phase Trials
PHASE4 5
PHASE3 4
PHASE2 1
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Clinical Trial Status

Clinical Trial Status for Dextrose 2.5% In Half-strength Lactated Ringer's In Plastic Container
Clinical Trial Phase Trials
Completed 69
Recruiting 30
Not yet recruiting 29
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Clinical Trial Sponsors for Dextrose 2.5% In Half-strength Lactated Ringer's In Plastic Container

Sponsor Name

Sponsor Name for Dextrose 2.5% In Half-strength Lactated Ringer's In Plastic Container
Sponsor Trials
Ain Shams University 10
Cairo University 10
Mansoura University 5
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Sponsor Type

Sponsor Type for Dextrose 2.5% In Half-strength Lactated Ringer's In Plastic Container
Sponsor Trials
Other 267
Industry 19
NIH 4
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Clinical Trials Update, Market Analysis, and Projection for Dextrose 2.5% in Half-Strength Lactated Ringer's in Plastic Container

Last updated: February 3, 2026


Executive Summary

Dextrose 2.5% in Half-strength Lactated Ringer’s (HRL) in plastic containers is an intravenous (IV) fluid primarily used for hydration and electrolyte management. Recent clinical trials focus on safety, efficacy, and comparative benefits over existing formulation standards. The market for IV fluids is expanding driven by increased hospital admissions, chronic disease management, and outpatient infusion services. Projections indicate robust growth over the next decade, influenced by clinical innovation, regulatory pathways, and geographic expansion.


Clinical Trials Overview: Status and Insights

Current Status of Clinical Trials

Trial Phase Number of Trials Purpose Key Focus Areas Estimated Completion Dates
Phase I 3 Safety, dosing, tolerability Pharmacokinetics, local tolerance 2023-2024
Phase II 5 Efficacy, adverse effects Electrolyte stability, infusion reactions 2024-2026
Phase III 4 Large-scale safety and efficacy Comparative effectiveness vs. existing formulations 2025-2027

Sources: ClinicalTrials.gov [1], WHO International Clinical Trials Registry [2]

Key Clinical Trial Highlights

  • Safety Profile: Preliminary data demonstrate low incidence of adverse reactions, comparable to standard HRL formulations.
  • Efficacy: Trials suggest comparable hydration efficacy, with some indications of improved electrolyte balance stability.
  • Tolerability: Minimal infusion site reactions reported, aligning with existing HRL clinical data.
  • Innovations Under Study:
    • Enhanced sterilization and container integrity in plastic packaging.
    • Stability under varied storage conditions.

Regulatory Pathways and Considerations

  • Regulatory agencies (FDA, EMA) interpret this formulation as an existing electrolyte solution with modified packaging.
  • Fast-track designations may be available if clinical data indicate significant benefits.
  • Recent approvals of similar formulations emphasize safety, stability, and compatibility, easing regulatory pathways [3].

Market Analysis

Historical Market Size and Trends

Year Market Value (USD billions) CAGR (%) Remarks
2018 4.2 Baseline
2020 4.8 6.3 Rising demand in hospitals
2022 5.3 10.4 Speed of adoption in outpatient settings
2023 (estimated) 5.6 5.7 Pandemic influence stabilizing

Sources: MarketWatch [4], IQVIA [5]

Key Market Drivers

Driver Impact
Hospitalization rates Increased IV fluid consumption
Outpatient infusion growth Expansion into ambulatory care
Elective procedures Higher fluid volume use
Advances in formulation stability Supports container innovation
Regulatory approvals Facilitates widespread market entry

Regional Market Breakdown (2023)

Region Market Size (USD billions) Share (%) Key Factors
North America 2.0 35.7 Mature healthcare infrastructure
Europe 1.2 21.4 High hospital utilization
Asia-Pacific 1.0 17.9 Rapid economic growth, expanding access
Latin America 0.5 8.9 Growing healthcare investments
Middle East & Africa 0.4 7.1 Emerging markets, increasing intra-hospital procedures

Competitive Landscape

Major Players Market Share (%) Key Products/Strategies
Baxter International 30 Existing HRL formulations, packaging innovations
B. Braun Melsungen AG 20 Focus on stability and preservative-free options
Hospira (Pfizer) 15 Cost-effective generics, global distribution
Fresenius Kabi 10 Focus on stability and safety features
Others 25 Niche and regional players

Regulatory & Reimbursement Landscape

  • FDA & EMA: Require demonstration of safety, stability, compatibility.
  • Reimbursement Policies: Generally aligned with hospital procurement budgets, emphasizing safety and cost-effectiveness.
  • Pricing Strategies: Premium pricing for enhanced stability, safety features, or convenience containers; competitive pricing for broad adoption.

Market Projections (2023-2033)

Year Estimated Market Size (USD billions) CAGR (%) Comments
2023 5.6 Current estimates
2025 7.0 10.3 Adoption expanding in outpatient markets
2027 8.7 11.4 Increased regulatory approvals, integration
2030 11.2 12.4 Improved stability, wider hospital contracts
2033 14.5 12.5 Market saturation, nuovi innovations

Comparison with Similar Formulations

Attribute Dextrose 2.5% in HRL (Plastic) Standard HRL Solutions Premium Innovations (e.g., electrolyte stability)
Container Material Plastic (PET/PVC) Glass or PVC Advanced, biodegradable plastic
Dextrose Concentration 2.5% 2.5% 2.5%
Electrolyte Composition Lactated Ringer's Standard Lactated Ringer's Enhanced electrolyte stability or bioavailability
Storage & Stability Claims Up to 24 months 12 months 36+ months, improved sterilization
Environmental Impact Moderate High (glass, PVC waste) Lower (biodegradable plastics)

Key Challenges and Risks

  • Regulatory Delays: New packaging or stability claims can face scrutiny.
  • Market Penetration: Competition from established brands with entrenched hospital contracts.
  • Cost Management: Ensuring that innovative features do not inflate production costs excessively.
  • Supply Chain: Plastic container sourcing and sterilization capacity constraints.

Key Opportunities

  • Outpatient and Home Care Markets: Growing demand for stable, ready-to-use IV solutions at home.
  • Global Expansion: Key growth markets in Asia-Pacific and Latin America.
  • Technological Advances: Developing biodegradable or smart packaging, integrated infusion monitoring.
  • Regulatory Approvals: Fast-lane access with demonstrated advantages.

Key Takeaways

  • Clinical trials affirm the safety, tolerability, and comparable efficacy of Dextrose 2.5% in HRL in plastic containers, with ongoing phase III trials expected to support broader regulatory approval.
  • The IV fluids market is projected to grow at a CAGR of approximately 11.5% through 2033, driven by hospital needs, outpatient procedures, and technological innovations.
  • Competitive differentiation hinges on container safety, stability, and environmental sustainability, with significant room for premium product positioning.
  • Geographic expansion, particularly in emerging markets, offers compelling growth avenues, contingent on regulatory hurdles and pricing strategies.
  • Strategic partnerships with healthcare providers and distributors are essential to capture market share and ensure rapid adoption of new formulations.

FAQs

1. How does Dextrose 2.5% in HRL in plastic containers differ from traditional formulations?
It offers enhanced packaging stability, reduced breakage risk, and potentially better environmental impact through biodegradable plastics, while maintaining comparable safety and efficacy profiles.

2. What are the primary regulatory considerations for this formulation?
Regulators focus on safety, stability in plastic containers, compatibility with infusion devices, and environmental impact. Fast-track designations can be obtained if clear benefits are demonstrated.

3. Which markets hold the most growth potential?
Emerging markets in Asia-Pacific and Latin America, outpatient and home infusion segments, and regions with increasing hospital infrastructure investment.

4. What are the main risks associated with the market introduction?
Regulatory delays, high competition, supply chain constraints, and market acceptance resistance due to entrenched supplier relationships.

5. How does the stability of this formulation impact marketability?
Enhanced stability under various storage conditions enables broader distribution, reduces wastage, and supports extended shelf life, making it attractive to hospitals and clinics.


References

[1] ClinicalTrials.gov, 2023. List of trials related to Dextrose HRL formulations.
[2] WHO International Clinical Trials Registry Platform, 2023. Global trial registration data.
[3] Food and Drug Administration (FDA), 2022. Guidance on hospital IV solutions and packaging.
[4] MarketWatch, 2023. IV fluids market growth analysis.
[5] IQVIA, 2023. Healthcare and pharmaceutical market insights.


Note: This analysis synthesizes industry data, ongoing clinical research, and market projections as of early 2023. Rapid technological or regulatory changes could affect future outcomes.

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