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

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

Condition Name

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

Condition MeSH

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

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

Trials by Country

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

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

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for Dextrose 5% And Ringer's In Plastic Container
Clinical Trial Phase	Trials
COMPLETED	167
Recruiting	72
Not yet recruiting	50

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

Sponsor Name

Sponsor Name for Dextrose 5% And 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% And Ringer's In Plastic Container
Sponsor	Trials
Other	504
Industry	45
OTHER_GOV	5

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

Last updated: April 24, 2026

What is the product and how is it used clinically?

Dextrose 5% and Ringer’s (in plastic container) is an IV fluid regimen that combines:

• Dextrose 5% (glucose solution) for energy support and fluid management
• Ringer’s solution components for electrolyte replacement and maintenance of fluid balance

Clinically, this class of product is used for intravenous hydration and electrolyte maintenance, typically in settings such as perioperative care, maintenance fluid therapy, and treatment of dehydration where clinicians seek a balanced glucose-electrolyte approach.

What is the clinical trial pipeline status?

No product-specific, dextrose 5% + Ringer’s in plastic container clinical trials with clear identifiers (e.g., NCT numbers) were located in the available evidence set for a 1:1 mapping to the exact commercial formulation and packaging term.

Clinical-trial activity that is typically relevant to this category is more commonly captured at the level of:

• comparative studies among IV maintenance fluids (e.g., normal saline vs balanced solutions vs dextrose-containing fluids),
• studies comparing crystalloid choices in specific indications (perioperative, pediatric maintenance, dehydration),
• formulation and safety studies that may be described at the solution class level rather than the exact “dextrose 5% and Ringer’s in plastic container” label.

Implication for decision-making: treat “clinical trial update” for this exact combination as low signal at the formulation-plus-packaging granularity. Market and procurement dynamics are more likely to drive adoption than new evidence programs for this standard IV regimen.

How should the market be sized and segmented for this therapy class?

Because the product is a standard IV fluid and is typically purchased through hospital procurement rather than reimbursed as a specialty drug, market measurement tends to follow:

• hospital consumption volumes (units of IV fluids),
• geography-wide tendering patterns,
• packaging format shifts (glass to plastic, and plastic bag volumes),
• regulatory approvals and local labeling.

Practical segmentation framework used by buyers

1. Hospital channel (primary): inpatient wards, perioperative units, emergency care, ICU (selectively based on clinical pathways).
2. Geography: US, EU5, UK, Japan, China, India, and “rest of world” for emerging procurement demand.
3. Container type: plastic container vs alternative packaging; plastic containers remain the default for large-volume distribution.

Demand drivers (structural)

• Ongoing global hospital volume and surgical incidence
• Standard-of-care maintenance fluid availability
• Procurement preference for plastic containers due to handling and distribution requirements
• Low barrier to entry for generic manufacturing (subject to regulatory compliance)

Where does “plastic container” change buyer economics?

Plastic container adoption is typically justified by:

• ease of handling and transport,
• reduction in breakage risk relative to glass,
• alignment with standardized IV workflow and ward storage.

For the category, packaging is a procurement spec. Once hospitals select approved vendors and formats, re-tender cycles drive volume shifts more than clinical differentiation.

Competitive landscape: what matters for market share?

Market share in this class tends to be determined by:

• regulatory approvals and consistent supply,
• hospital formulary inclusion,
• tender performance (price, delivery reliability),
• manufacturing scale and QA capacity for IV solutions.

Clinical differentiation is limited for this specific combination compared with specialty therapeutics; the commercial differentiator is usually cost and supply continuity.

What is the market outlook and projection logic?

This projection is built on standard IV fluid procurement math:

• Base demand tracks hospital usage and population growth.
• Volume intensity depends on surgical and inpatient days.
• Price erosion is common due to competition and generic substitution.
• Packaging conversion to plastic containers is mature in most developed markets and still progressive in parts of emerging markets.

Projection approach (category-level logic)

Because product-specific consumption data for “dextrose 5% and Ringer’s in plastic container” is not consistently published at that exact granularity, projections for investment or planning are best modeled as:

• share-of-wallet within maintenance fluid categories,
• plastic-container share within IV crystalloid categories,
• tender-driven unit volumes.

Expected trajectory

• Moderate volume growth over the medium term from hospital demand and surgical throughput.
• Downward pressure on unit price as supply expands and generics compete.
• Stable profitability for compliant, scaled manufacturers if procurement wins sustain volume.

Regulatory and labeling considerations that affect supply

For IV solution products, compliance typically centers on:

• container suitability and material compatibility,
• sterility assurance and particulate limits,
• stability and shelf-life controls,
• local labeling requirements for indications and administration instructions.

Packaging matters for:

• compatibility with infusion systems,
• extractables/leachables controls (plastic container),
• transport and storage conditions.

Commercial implications: what to do now

For R&D teams

If the goal is differentiation, consider programs that can clear tender hurdles:

• packaging performance improvements that reduce visual particulate risk and shipping losses,
• stability/shelf-life optimization that improves distribution economics,
• safety-by-design features at the workflow level (e.g., compatibility with standard administration sets).

If the goal is a new evidence package, target clinical outcomes that procurement committees accept, usually studies framed around:

• perioperative or maintenance fluid safety endpoints,
• electrolyte balance outcomes,
• practical workflow comparisons.

For investors and business development

Value is most often captured via:

• manufacturing scale and supply reliability,
• tender access and formulary lock-in,
• vertical integration of sterilization, filling, and QA.

What is the likely timeline to see market share movement?

Market share in this product class typically moves during:

• hospital formulary renewals,
• regional tender cycles,
• post-supply interruption rerouting (short-term winners can emerge based on reliability).

Those cycles are usually measured in months to 2 years, not 5-10 year evidence-driven horizons.

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Key Takeaways

• Clinical trial signal for the exact “dextrose 5% and Ringer’s in plastic container” combination is low at the granularity required for a product-specific update; activity is more often categorized at the IV maintenance fluid class level.
• The market is primarily hospital procurement-led, where packaging spec (plastic container) and supply reliability drive purchasing.
• Near-term demand is expected to grow with hospital utilization, while pricing faces generic competition and tender pressure.
• Competitive advantage is most likely to accrue to scaled manufacturers with consistent regulatory compliance and tender execution.

FAQs

1. Is dextrose 5% and Ringer’s a specialty drug with strong trial-driven differentiation?
   No. It is typically treated as a standard IV maintenance fluid with procurement-led adoption rather than evidence-led specialty positioning.

2. What endpoints would matter most in future trials for this category?
   Endpoints that support routine use decisions: electrolyte and fluid balance safety, perioperative maintenance tolerability, and practical administration outcomes.

3. Does plastic container status change regulatory or procurement requirements?
   Yes. Container format is often embedded in tender specifications and affects logistics, workflow, and quality requirements.

4. What drives market share more than clinical studies?
   Tender outcomes, formulary inclusion, supply continuity, and unit economics under hospital purchasing contracts.

5. How should market projections be modeled for this product?
   Use a category-based procurement model: hospital demand growth, plastic-container share, and expected price erosion from competition.

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References (APA)

[1] U.S. National Library of Medicine. (n.d.). ClinicalTrials.gov. https://clinicaltrials.gov/