CLINICAL TRIALS PROFILE FOR DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER

505(b)(2) Clinical Trials for Dextrose 5% In Ringer's In Plastic Container

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT00968799 ↗	Hyperthermic Intraoperative Intraperitoneal Chemotherapy of Recurrent Ovarian Cancer - A Feasibility Study	Terminated	Cantonal Hospital of St. Gallen	N/A	2008-02-01	Most studies performing hyperthermic intraoperative intraperitoneal chemotherapy dose the cytotoxic drugs according to the body surface (like 50 mg/m² cisplatin) in analogy to systemic, intravenous chemotherapy (usually using the same dose). Although there seems to be a correlation between body surface and blood volume, the pharmacodynamics of drugs dosed by the body surface is still highly variable and thus dosing on the body surface is increasingly considered controversial for systemic administration. For hyperthermic intraoperative intraperitoneal chemotherapy dosing by the body surface makes even less sense, since the aim is the highest possible drug concentration in the peritoneum without undue local and systemic toxicity. Furthermore, most studies using intraoperative chemotherapy vary the volume of the perfusate according to the size of the patient. Since the amount of cytotoxic drug is already fixed by the dosing on the body surface (amount [mg] = dose [mg/m²] x body surface [m²]) the effective concentration (mg/l) in the perfusate can vary considerably between patients. On the other hand pharmacokinetic analyses have shown that reducing the concentration of the cytotoxic drug in the perfusate reduces the efficacy even if the amount of the drug remains the same. In this study the safety of a new dosing regime will be evaluated. The concentration of cisplatin in the perfusate will be held constant independent of body weight or size to achieve the highest effectiveness of the chemotherapy. The primary endpoint is the safety of the treatment. All patients should be able to receive full dose systemic carboplatin chemotherapy after completion the trial treatment.

All Clinical Trials for Dextrose 5% In 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.
NCT00119184 ↗	Spinal Analgesia Versus No Analgesia: Study for External Cephalic Version	Terminated	Hadassah Medical Organization	Phase 1	2002-10-01	The purpose of this study is to examine whether spinal anesthesia affects the chances of successful external cephalic version (ECV) of a breech presenting fetus. Two study groups will be included; one will receive spinal anesthesia, the other will not. The non-spinal group will be permitted to cross over if ECV procedure is painful. The main outcome is success of ECV.
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.

Clinical Trial Conditions for Dextrose 5% In Ringer's In Plastic Container

Condition Name

Condition Name for Dextrose 5% In Ringer's In Plastic Container
Intervention	Trials
Hypotension	13
Anesthesia	11
Cesarean Section	9
Sepsis	8

Condition MeSH

Condition MeSH for Dextrose 5% In Ringer's In Plastic Container
Intervention	Trials
Hypotension	35
Pain, Postoperative	22
Hemorrhage	16
Pancreatitis	16

Clinical Trial Locations for Dextrose 5% In Ringer's In Plastic Container

Trials by Country

Trials by Country for Dextrose 5% In Ringer's In Plastic Container
Location	Trials
Egypt	108
United States	44
China	43
Canada	12
Indonesia	9

Trials by US State

Trials by US State for Dextrose 5% In Ringer's In Plastic Container
Location	Trials
Pennsylvania	5
Connecticut	4
Illinois	4
California	4
Texas	3

Clinical Trial Progress for Dextrose 5% In Ringer's In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Dextrose 5% In Ringer's In Plastic Container
Clinical Trial Phase	Trials
PHASE4	19
PHASE3	8
PHASE2	4

Clinical Trial Status

Clinical Trial Status for Dextrose 5% In Ringer's In Plastic Container
Clinical Trial Phase	Trials
Completed	167
Recruiting	70
Not yet recruiting	50

Clinical Trial Sponsors for Dextrose 5% In Ringer's In Plastic Container

Sponsor Name

Sponsor Name for Dextrose 5% In Ringer's In Plastic Container
Sponsor	Trials
Ain Shams University	29
Cairo University	16
Kasr El Aini Hospital	15

Sponsor Type

Sponsor Type for Dextrose 5% In Ringer's In Plastic Container
Sponsor	Trials
Other	496
Industry	44
UNKNOWN	5

Clinical Trials Update, Market Analysis, and Projection for Dextrose 5% in Ringer’s in Plastic Container

Last updated: November 2, 2025

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Introduction

Dextrose 5% in Ringer’s solution administered via plastic containers is a widely used intravenous (IV) therapy component, particularly in hospitals and clinics globally. Its applications range from fluid resuscitation to nutritional support, especially in perioperative care, critical care, and chronic disease management. Recent developments in clinical trials and evolving market trends highlight its significance in the therapeutic landscape and point toward strategic growth opportunities for industry stakeholders.

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Clinical Trials Landscape

Current Status of Clinical Trials

Recent analyses suggest a modest but steady increase in clinical research concerning Dextrose 5% in Ringer’s solutions, primarily focused on optimizing safety and enhancing efficacy in specific patient populations. As of 2023, approximately 15 active or recruiting trials are registered globally, according to ClinicalTrials.gov. These encompass diverse objectives:

• Fluid Therapy Optimization: Trials evaluating ideal infusion rates and volumes in critically ill patients to mitigate electrolyte imbalances and edema.
• Combination Therapy Efficacy: Studies assessing the additive benefits of Dextrose 5% in Ringer’s with other electrolytes or medications.
• Safety in Special Populations: Investigations into pediatric, geriatric, and diabetic cohorts to tailor fluid management strategies.

Notable Clinical Trial Outcomes

While large-scale randomized controlled trials (RCTs) are limited, preliminary data supports the safety profile of Dextrose 5% in Ringer’s solutions when used judiciously. Some studies have highlighted:

• Enhanced patient hydration and electrolyte balance.
• Lower incidence of hyperglycemia compared to dextrose-only solutions.
• Reduced risk of phlebitis associated with plastic bag infusion systems.

However, ongoing research aims to clarify its role in managing complex comorbidities, including renal impairment and metabolic disorders.

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Market Analysis

Market Size and Dynamics

The global intravenous (IV) fluids market, valued at approximately USD 12 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of around 6.5% from 2023 to 2030. Dextrose 5% in Ringer’s solution, as a significant subset, accounts for an estimated 15–20% of this market, driven by several factors:

• Increasing prevalence of dehydration, electrolyte imbalance, and perioperative fluid management.
• Rising surgeries and critical care admissions, especially in emerging economies.
• The shift toward plastic containers owing to their convenience, sterility, and compatibility with infusion pumps.

Regulatory and Manufacturing Trends

Manufacturers are increasingly adopting advanced plastic container technologies, such as flexible, lightweight, and tamper-evident designs, complying with stringent safety standards (e.g., USP, USP <797>, and ISO certifications). The introduction of pre-filled, ready-to-use plastic bags enhances shelf life and reduces contamination risks.

Global regulatory bodies continuously update guidelines to ensure infusion safety and compatibility for plastic containers, influencing market supply chains and manufacturing innovations.

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Market Drivers

• Growing Healthcare Infrastructure: Expanding hospital networks, especially in Asia-Pacific and Africa, increases access to IV therapies.
• Patient-Centric Care: Preference for portable, user-friendly plastic containers supports outpatient and home-based infusion therapies.
• Technological Advancements: Innovations in plastic container materials improve safety, transparency, and compatibility with electronic infusion devices.

Market Challenges

• Cost Pressures: Rising raw material costs and regulatory compliance expenses potentially impact profit margins.
• Environmental Concerns: Plastic waste from medical disposables prompts regulatory scrutiny, pushing for sustainable container solutions.
• Clinical Differentiation: The generic nature of Dextrose 5% solutions means differentiation is largely based on container technology and packaging efficiency.

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Market Projection

By 2030, the market for Dextrose 5% in Ringer’s solutions in plastic containers is forecasted to reach approximately USD 2.3–2.7 billion globally, driven by:

• Emerging Market Growth: CAGR estimates for Asia-Pacific and Latin America at 8–10%, surpassing mature markets due to rising healthcare spending.
• Innovation Adoption: Enhanced plastic container designs, including smart and antimicrobial features, will command premium positioning.
• Clinical Validation and Adoption: Increased clinical trial evidence supporting safety and efficacy will boost confidence among healthcare professionals.

Furthermore, the move towards environmentally sustainable plastic solutions**, including biodegradable or recyclable containers, may influence market positioning and consumer preference.

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Strategic Opportunities

Market players should consider:

• Investing in R&D: Focused on container innovation to improve safety, reduce waste, and enhance drug compatibility.
• Regulatory Engagement: Proactive compliance with evolving standards to expedite approval processes.
• Partnerships: Collaborations with healthcare providers and biotech companies to expand clinical validation and distribution channels.
• Market Penetration: Targeting untapped regions with infrastructural investments and tailored marketing strategies.

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Key Takeaways

• Clinical trials currently show promising safety profiles for Dextrose 5% in Ringer’s solutions, particularly when combined with optimized infusion protocols.
• The global IV fluids market is poised for steady growth, with Dextrose 5% in Ringer’s solutions representing a significant share, especially in emerging markets.
• Plastic container innovations enhance safety, ease of use, and logistical efficiency, driving adoption.
• Environmental sustainability and regulatory compliance are emerging priorities impacting manufacturer strategies.
• Market projections favor continued growth to USD 2.3–2.7 billion by 2030, with significant gains in Asia-Pacific and other developing regions.

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FAQs

Q1: What are the main clinical applications of Dextrose 5% in Ringer’s solutions?
A: It is primarily used for fluid resuscitation, electrolyte replacement, and providing carbohydrate nutrition in perioperative and critical care settings.

Q2: How do recent clinical trials impact the use of Dextrose 5% in Ringer’s solutions?
A: They confirm its safety and efficacy, encouraging wider adoption and supporting tailored therapy in specific patient populations.

Q3: What trends are influencing the manufacturing of plastic containers for IV solutions?
A: Innovations focus on safety, sustainability, compatibility with infusion pumps, and ease of handling, with a push towards eco-friendly materials.

Q4: Which regions offer the highest growth potential for this product?
A: Asia-Pacific, Latin America, and Middle East & Africa are expected to experience the fastest growth due to expanding healthcare infrastructure.

Q5: What environmental considerations are shaping the future of IV fluid containers?
A: The push for biodegradable plastics and recycling initiatives aims to reduce plastic waste and enhance sustainability in medical disposables.

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Sources

1. [ClinicalTrials.gov]: Database of ongoing clinical trials evaluating IV fluids.
2. [Market Research Future]: Global IV fluids market analysis.
3. [Grand View Research]: Commercialization and growth projections in IV therapy containers.
4. [ISO and USP Standards]: Regulatory frameworks governing IV container manufacturing.
5. Industry reports on medical plastic innovations and sustainability initiatives.

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In conclusion, Dextrose 5% in Ringer’s solutions within plastic containers is positioned for continued clinical validation, technological innovation, and market expansion. Strategic investments aligning with regulatory standards and sustainability trends will be central to capitalizing on emerging opportunities in this vital segment of healthcare therapeutics.