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.
NCT00273728 ↗	BaSES Trial: Basel Starch Evaluation in Sepsis	Completed	Fresenius AG	Phase 4	2005-05-01	Background: In patients with severe sepsis and septic shock early aggressive volume replacement reduced mortality. Standard infusion therapy consists of crystalloid infusions. The role of modern, low molecular weight, starch preparations and their influence on the course of disease is not determined yet. Hypothesis: The purpose of this study is to determine wether initial infusion therapy with Hydroxyethylstarch and Ringer's lactate reduces in septic patients reduces Intensive Care Unit and hospital length of stay without impairment of renal function Design: Double-blind, randomized, controlled monocentric study Setting: Intensive Care Units of a University Hospital Patients: 240 consecutive patients with sepsis, severe sepsis and septic shock Intervention: Volume therapy with Ringer's lactate and saline or hydroxy-ethyl starch (MW 130, substitution 0.4) in the first five days of intensive care treatment. Parameter: - Intensive Care length of stay - Hospital length of stay - Mortality - Kidney function Statistics: Mann-Whitney test for non-parametric data like intensive care length of stay. Unpaired t-Test for kidney function parameters. Study withdrawal: Significant impairment of kidney function parameters in the hydroxy-ethyl starch group
NCT00273728 ↗	BaSES Trial: Basel Starch Evaluation in Sepsis	Completed	University Hospital, Basel, Switzerland	Phase 4	2005-05-01	Background: In patients with severe sepsis and septic shock early aggressive volume replacement reduced mortality. Standard infusion therapy consists of crystalloid infusions. The role of modern, low molecular weight, starch preparations and their influence on the course of disease is not determined yet. Hypothesis: The purpose of this study is to determine wether initial infusion therapy with Hydroxyethylstarch and Ringer's lactate reduces in septic patients reduces Intensive Care Unit and hospital length of stay without impairment of renal function Design: Double-blind, randomized, controlled monocentric study Setting: Intensive Care Units of a University Hospital Patients: 240 consecutive patients with sepsis, severe sepsis and septic shock Intervention: Volume therapy with Ringer's lactate and saline or hydroxy-ethyl starch (MW 130, substitution 0.4) in the first five days of intensive care treatment. Parameter: - Intensive Care length of stay - Hospital length of stay - Mortality - Kidney function Statistics: Mann-Whitney test for non-parametric data like intensive care length of stay. Unpaired t-Test for kidney function parameters. Study withdrawal: Significant impairment of kidney function parameters in the hydroxy-ethyl starch group
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.

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
Septic Shock	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	110
China	45
United States	44
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	5

Clinical Trial Status

Clinical Trial Status for Dextrose 5% In Ringer's In Plastic Container
Clinical Trial Phase	Trials
Completed	167
Recruiting	72
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	18
Kasr El Aini Hospital	15

Sponsor Type

Sponsor Type for Dextrose 5% In Ringer's In Plastic Container
Sponsor	Trials
Other	504
Industry	45
UNKNOWN	5

Last updated: May 8, 2026

Dextrose 5% in Ringer’s (plastic container): clinical-trials update and market projection

What is the product and how is it typically used?

“Dextrose 5% in Ringer’s” is an intravenous (IV) combination fluid where dextrose 5% is added to a Ringer’s solution base. In practice, the product is used for fluid resuscitation and maintenance, and for providing calories via dextrose, with dosing and indication language governed by the specific country label and manufacturer formulation.

Because this is a standard IV fluid (not a proprietary small-molecule or biologic), clinical development is usually limited to formulation, container, and regulatory compliance trials, not novel mechanism-of-action efficacy programs. The “in plastic container” aspect points to packaging and stability/regulatory equivalence rather than therapeutic innovation.

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What does the clinical-trials landscape look like (update)?

No actionable “drug development” clinical trial program is identifiable for this category at the level typically required to produce a meaningful update (phase-by-phase efficacy endpoints, investigators, enrollment, timelines). For IV admixture fluids and standard solutions, the dominant clinical evidence generation in public registries tends to be:

• Bridging or equivalence studies for new container materials (e.g., plastic vs glass), hold times, and administration settings
• Stability and compatibility assessments (often not registered as classic interventional “clinical trials”)
• Labeling updates from regulatory submissions using pharmacopeial standards rather than new clinical endpoints

As a result, a rigorous clinical-trials update for “Dextrose 5% in Ringer’s in plastic container” cannot be produced with the level of specificity expected for a blockbuster-like asset (unique trial IDs, trial sizes, phase, primary endpoints, top-line results).

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How does the market behave for this category?

This segment trades primarily on:

• Regulatory availability and supply continuity
• Tender and hospital procurement cycles
• Pricing discipline driven by government and group purchasing organizations
• Packaging and distribution logistics (plastic container formats, breakage resistance, shipping efficiency)

Demand drivers are broad and structural:

• Hospital volumes for perioperative care, emergency care, pediatrics, and maintenance IV therapy
• Ongoing use for fluid management protocols in adults and children

Competitive structure is fragmented by geography with multiple authorized manufacturers, including:

• Global IV solution suppliers
• Local generic manufacturers
• Contract manufacturing tied to hospital tender schedules

Because it is not a patented, novel drug in the classic sense, “market share” is usually secured via procurement contracts, not via evidence of superior efficacy.

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What is the likely projection path (volume and value)

A credible projection for this product category must be anchored to IV solutions market growth and hospital procurement expansion rather than to trial-driven adoption. In most markets, growth is tied to:

• Population and hospital utilization
• Inflation-linked pricing (value growth)
• Substitution stability (volume growth often modest relative to value)

For projection purposes, the most defensible approach is to treat this as part of the IV fluids / parenteral nutrition-adjacent supportive care spend rather than as a standalone “drug” with adoption curves.

Baseline projection logic (category-level):

• Volume growth: low to mid single digits annually in mature markets, higher in emerging markets with improving hospital capacity
• Value growth: tracks inflation and tender pricing, often higher than volume growth
• Packaging-driven share shifts: gradual; “plastic container” adoption is typically already mature in many regions because it reduces shipping damage and handling cost

A standalone forecast cannot be credibly expressed here in numeric CAGR, TAM, or unit volumes for this exact SKU without a specific market dataset tied to this exact product name, strength, and pack size.

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What risks and constraints shape commercialization?

Key constraints for an IV fluid like this are operational and regulatory:

• Supply continuity risk: polymer film supply, resin costs, and container manufacturing capacity
• Quality system requirements: batch release, sterility assurance, and container integrity testing
• Pricing pressure: generic competition and procurement tender dynamics
• Protocol dependence: hospital fluid protocols and guideline changes can shift mix among crystalloids, dextrose-containing solutions, and electrolyte variants

Even small protocol shifts can affect mix because IV solutions compete within the same clinical pathways.

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What is the most investable “leverage” in this category?

For investors or R&D partners, the practical levers are not clinical differentiation but:

• Regulatory approvals for container formats (plastic film variants, shelf-life, compatibility claims)
• Cost-down execution (packaging economics, container material optimization, scale manufacturing)
• Contracting capability (hospital and government tender win rates)

This is a procurement-and-manufacturing business model more than a clinical-adoption model.

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Key Takeaways

• Clinical trials for “dextrose 5% in Ringer’s (plastic container)” are typically limited to equivalence, packaging, stability, and regulatory compliance, not novel efficacy programs.
• Market demand is procurement-driven and depends on hospital fluid-management protocols and tender cycles rather than phase-by-phase adoption.
• Projection must be category-based (IV fluids/supportive care) because the product behaves like a standard, multi-source therapeutic supply item rather than a trial-requiring innovation.
• Commercial leverage is operational: container approvals, manufacturing scale, and tender execution.

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FAQs

1. Is “Dextrose 5% in Ringer’s” a patented, innovation-driven drug?
   It is typically treated as a standard IV fluid formulation with multi-source manufacture and procurement-led adoption.

2. Do we see meaningful Phase 3 trials for this product?
   In general, classic Phase 3 efficacy trials are uncommon because this is not a novel mechanism product; available evidence is usually regulatory and equivalence-oriented.

3. Why does “plastic container” matter commercially?
   It affects packaging logistics, handling, and regulatory equivalence claims tied to container integrity and stability.

4. What most affects market share?
   Hospital and government contracting, pricing, supply reliability, and approved packaging formats.

5. How should forecasts be modeled?
   Use IV fluids category growth drivers and procurement pricing/inflation dynamics; avoid asset-like diffusion models tied to new clinical outcomes.

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References

1. World Health Organization. WHO Model Formulary for Children: Medicines for children (supportive IV fluids context). World Health Organization.
2. U.S. National Library of Medicine. ClinicalTrials.gov database search results for “dextrose ringer’s” and related terms.
3. European Medicines Agency. Regulatory guidance and container/quality considerations for sterile solutions (general framework).