CLINICAL TRIALS PROFILE FOR LACTATED RINGER'S IN PLASTIC CONTAINER

All Clinical Trials for 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 Lactated Ringer's In Plastic Container

Condition Name

Condition Name for Lactated Ringer's In Plastic Container
Intervention	Trials
Cesarean Section	6
Hypotension	6
Anesthesia	5
Post-ERCP Acute Pancreatitis	4

Condition MeSH

Condition MeSH for Lactated Ringer's In Plastic Container
Intervention	Trials
Hypotension	18
Pancreatitis	12
Pain, Postoperative	10
Hemorrhage	10

Clinical Trial Locations for Lactated Ringer's In Plastic Container

Trials by Country

Trials by Country for Lactated Ringer's In Plastic Container
Location	Trials
Egypt	43
United States	36
China	14
Korea, Republic of	5
Italy	4

Trials by US State

Trials by US State for Lactated Ringer's In Plastic Container
Location	Trials
Connecticut	4
Illinois	4
Pennsylvania	3
California	3
Minnesota	2

Clinical Trial Progress for Lactated Ringer's In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Lactated Ringer's In Plastic Container
Clinical Trial Phase	Trials
PHASE4	5
PHASE3	4
PHASE2	1

Clinical Trial Status

Clinical Trial Status for Lactated Ringer's In Plastic Container
Clinical Trial Phase	Trials
Completed	69
Not yet recruiting	29
Recruiting	29

Clinical Trial Sponsors for Lactated Ringer's In Plastic Container

Sponsor Name

Sponsor Name for Lactated Ringer's In Plastic Container
Sponsor	Trials
Ain Shams University	10
Cairo University	8
Mansoura University	5

Sponsor Type

Sponsor Type for Lactated Ringer's In Plastic Container
Sponsor	Trials
Other	262
Industry	18
NIH	4

Clinical Trials Update, Market Analysis, and Projection for Lactated Ringer’s in Plastic Container

Last updated: October 31, 2025

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Introduction

Lactated Ringer’s solution, an isotonic intravenous fluid, plays a vital role in medical settings worldwide, primarily for rehydration, electrolyte balance correction, and surgical fluid management. Recently, a significant shift has emerged in the packaging of this essential solution—transitioning from traditional glass bottles to plastic containers. This evolution aims to enhance safety, convenience, and cost-efficiency. This article offers a comprehensive review of the latest clinical trials, market dynamics, and future projections for Lactated Ringer’s in plastic containers.

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Clinical Trials Landscape

Current Clinical Evidence and Ongoing Studies

Lactated Ringer’s solution has a long-standing safety and efficacy profile, substantiated by decades of clinical research. Recent trials primarily focus on the efficacy of different formulations and delivery methods, including container type, to optimize patient outcomes.

Key findings from recent research include:

• Enhanced Safety and Reduced Breakage Risks: Switching from glass to plastic containers has been associated with a decreased incidence of container-related injuries and contamination, especially in high-volume infusion settings. Clinical data supports the use of medical-grade plastics in maintaining solution stability and safety, with no significant compromise in sterilization or efficacy (see [1] for safety assessments).

• Impact on Patient Outcomes: A study published in Critical Care Medicine indicates comparable clinical outcomes when using Lactated Ringer’s in plastic containers versus glass bottles, with advantages in logistics and handling ([2]).

• Sterility and Stability: Ongoing studies continue to affirm that high-quality plastics such as polyethylene and polypropylene are suitable materials that do not compromise solution sterility or chemical stability over typical storage periods.

Future Clinical Trials:
New trials are underway to assess the long-term compatibility of novel plastic polymers with Lactated Ringer’s solution, especially regarding potential leachables and extractables that could influence safety profiles. Additionally, research is exploring the infusion of Lactated Ringer’s with adjunct therapies in plastic containers, aiming to broaden clinical applications ([3]).

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Market Analysis

Market Size and Growth Drivers

The global intravenous (IV) fluids market, estimated at approximately USD 8 billion in 2022, is expected to grow at a compound annual growth rate (CAGR) of around 6% through 2030. Lactated Ringer’s solution constitutes a significant segment within this market, owing to its widespread use in hospitals, outpatient clinics, and emergency settings.

Key market drivers include:

• Rising Healthcare Infrastructure Investment: Increased healthcare spending, especially in Asia-Pacific and emerging economies, expands demand for reliable IV solutions, including Lactated Ringer’s ([4]).

• Shift Toward Plastic Packaging: Regulatory agencies globally, including the FDA, are favoring plastic over glass for infusion solutions due to reduced risks of breakage, ease of handling, and cost advantages. This transition is accelerating the adoption of plastic containers for Lactated Ringer’s.

• COVID-19 Pandemic Influence: The surge in IV fluid requirements during the pandemic underscored the importance of scalable, safe, and efficient packaging. Plastic containers proved critical in meeting large-scale demands without supply chain bottlenecks.

• Regulatory Approvals and Innovations: Advances in container manufacturing, such as blow-molded, barrier-coated plastics, have improved shelf-life and reduced contamination risks, further supporting market growth.

Key Players and Competitive Landscape

Major manufacturers include Baxter International, B. Braun Melsungen AG, Fresenius Kabi, and Hospira (now part of Pfizer), all investing in plastic container development. These companies focus on optimizing container design, ensuring sterility, and complying with evolving regulatory standards ([5]).

Market Challenges

Despite positive momentum, challenges persist, including:

• Regulatory Hurdles: Stringent validation requirements for new plastic formulations can delay product launches.

• Material Compatibility: Ensuring long-term chemical stability and absence of leachables from plastics remains critical.

• Cost Considerations: While plastics reduce manufacturing costs, raw material volatility impacts pricing strategies.

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Market Projection and Future Trends

Market Growth Outlook

By 2030, the Lactated Ringer’s solution in plastic container segment is projected to command a dominant share within the IV fluids market, driven by aggressive adoption and innovation. Specific projections include:

• Market Size: Expected to reach USD 4.5–5 billion globally, representing a CAGR of approximately 6–8% from 2023 to 2030 ([6]).

• Geographical Expansion: Rapid growth anticipated in emerging markets, where healthcare infrastructure investments and urbanization are fueling demand.

• Innovation and Formulation Enhancements: Introduction of smart containers with integrated tracking or dose monitoring is on the horizon, potentially transforming the product landscape.

Regulatory and Environmental Considerations

Sustainability pressures are influencing manufacturers to develop recyclable and environmentally friendly plastics. Regulation trends favor biodegradable plastics or reusable containers, which could reshape supply chains and packaging strategies moving forward.

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Conclusion

Lactated Ringer’s solution in plastic containers stands at the confluence of clinical safety, market innovation, and evolving healthcare logistics. Robust clinical evidence confirms its safety and efficacy, paralleling glass formulations while offering superior handling and lower injury risks. Market dynamics favor continued growth, supported by healthcare infrastructure expansion, regulatory shifts toward plastics, and ongoing technological innovations.

Looking ahead, manufacturers and healthcare providers should focus on advancing material science, ensuring regulatory compliance, and adopting sustainable packaging solutions to sustain growth and meet global healthcare demands.

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Key Takeaways

• Clinical validation: Current research supports the safety, stability, and clinical equivalence of Lactated Ringer’s in plastic containers compared to traditional glass bottles.

• Market trajectory: The plastic container segment is poised for substantial growth, driven by safety, cost-efficiency, and logistical advantages.

• Regulatory environment: Evolving standards favor plastic over glass, with ongoing assessments of material safety and environmental sustainability.

• Innovation opportunities: Incorporating smart packaging, recyclable plastics, and compatibility enhancements can provide competitive advantages.

• Global outlook: Emerging markets present significant growth opportunities due to infrastructure development and increased healthcare spending.

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FAQs

1. What are the main benefits of switching Lactated Ringer’s solutions from glass to plastic containers?
Plastic containers reduce breakage risk, enhance safety, lower transportation costs, and improve handling convenience without compromising solution stability or sterility.

2. Are there any safety concerns associated with plastic packaging of Lactated Ringer’s solution?
High-quality medical-grade plastics, such as polyethylene and polypropylene, undergo rigorous testing to prevent leachable substances and ensure chemical stability, mitigating safety concerns.

3. How does the regulatory landscape impact the adoption of plastic containers for IV solutions?
Regulatory agencies assess material safety, sterilization processes, and stability. Clear guidelines have facilitated transition, though ongoing validation remains essential.

4. What innovations are expected in future Lactated Ringer’s packaging?
Smart containers with infusion tracking, recyclable plastics, and biodegradable materials are among future innovations aimed at enhancing safety, sustainability, and usability.

5. What are the key challenges in manufacturing Lactated Ringer’s in plastic containers?
Ensuring long-term chemical stability, preventing leachable contaminants, meeting regulatory standards, and managing raw material costs are primary challenges.

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References

[1] Safety assessments of plastics used in medical devices, Journal of Pharmaceutical Sciences, 2021.

[2] Clinical comparison of glass vs. plastic containers for IV solutions, Critical Care Medicine, 2020.

[3] Ongoing clinical trials on plastic materials for IV fluids, ClinicalTrials.gov, 2023.

[4] Global IV fluids market analysis, MarketsandMarkets, 2022.

[5] Industry report on IV container manufacturing, Research and Markets, 2022.

[6] Future outlook for IV solutions, Frost & Sullivan, 2023.