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

All Clinical Trials for Dextrose 5% In Acetated Ringer's In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01250886 ↗	Acid-base Balance in Patients Undergoing Colonoscopy	Unknown status	Mahidol University	Phase 1	2010-12-01	The purpose of this study is to determine whether fluid administration in patients undergoing colonoscopy should affect acid-base disorder in term of the strong ion differences.
NCT01438502 ↗	"The Effect of Reduced Fluid Load After Cardiac Surgery"	Withdrawn	Haukeland University Hospital		1969-12-31	The purpose of this study is to verify that an infusion of hypertonic saline/colloids during cardio-pulmonary-bypass will reduce fluid overload and organ edema for cardiac patients with expected long-CPB-time. Expected beneficial effects are improved organ function for heart and lungs.
NCT01511120 ↗	The Effect on Fluid Balance After Cardiac Surgery After Use of Two Different Priming Protocols	Completed	Haukeland University Hospital	Phase 2	2011-11-01	"The impact on fluid loading after cardiac surgery by use of two different priming solution" Fluid overloading with oedema formation is a regular finding following on-pump cardiac surgery and may contribute to postoperative organ dysfunction. Myocardial oedema has been reported to impair both systolic and diastolic function. An association between intraoperative fluid loading and postoperative adverse outcome has been demonstrated in cardiac patients. The investigators have experience with the use of both colloides and combination fluids (hypertonic saline/colloides) in several experimental studies (pigs). In one animal study the investigators used colloides as an additive to the CPB-prime. The investigators observed reduced fluid leakage and less total tissue water in several organs. The planned study includes patients scheduled for coronary artery bypass, and who have no co-morbidity. The patients will be randomized to receive either Tetraspan® (HES) or acetated Ringer's solution in the CPB-prime. Accurate accounts of fluid additions, blood loss and diuresis will be kept. Determination of cardiac output (C.O.), intrathoracic blood volume (ITBV), extravascular lung water (EVLW) and global end diastolic volume (GEDV) will be monitored by use of the transpulmonary thermodilution technique PiCCO®plus system.
NCT02079064 ↗	Effects of Desflurane Versus Propofol on Hemostasis During Splenectomy	Completed	Theodor Bilharz Research Institute	N/A	2014-01-01	The aim of this prospective randomized study is to evaluate the perioperative effects of inhalational anesthesia (desflurane) and intravenous anesthesia (propofol) on hemostasis in patients undergoing splenectomy with liver cirrhosis guided by the new technology (ROTEM) and the traditional laboratory hemostatic markers.

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

Condition Name

Condition Name for Dextrose 5% In Acetated Ringer's In Plastic Container
Intervention	Trials
Coronary Heart Disease	1
Septic Shock Hyperdynamic	1
Fluid Loss	1
Status; Splenectomy	1

Condition MeSH

Condition MeSH for Dextrose 5% In Acetated Ringer's In Plastic Container
Intervention	Trials
Shock, Septic	2
Hypovolemia	1
Heart Diseases	1
Shock	1

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

Trials by Country

Trials by Country for Dextrose 5% In Acetated Ringer's In Plastic Container
Location	Trials
Egypt	2
Norway	2
China	1

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

Clinical Trial Phase

Clinical Trial Phase for Dextrose 5% In Acetated Ringer's In Plastic Container
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for Dextrose 5% In Acetated Ringer's In Plastic Container
Clinical Trial Phase	Trials
Completed	3
Unknown status	2
Not yet recruiting	2

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

Sponsor Name

Sponsor Name for Dextrose 5% In Acetated Ringer's In Plastic Container
Sponsor	Trials
Haukeland University Hospital	2
Oslo University Hospital	1
Ain Shams University	1

Sponsor Type

Sponsor Type for Dextrose 5% In Acetated Ringer's In Plastic Container
Sponsor	Trials
Other	10

Last updated: August 1, 2026

Clinical trials update, market analysis and projection for Dextrose 5% in Acetated Ringer’s in plastic container

No complete, decision-grade patent or market dataset is available for this specific drug presentation (Dextrose 5% in acetated Ringer’s in plastic container). Without a uniquely identifiable FDA product, sponsor/labeler, NDC/route strength, and a corresponding patent/clinical-trials record set, a complete and accurate clinical trials update and market projection cannot be produced.

What clinical trials exist for Dextrose 5% in Acetated Ringer’s plastic container?

No uniquely attributable clinical-trials corpus is available for this exact combination and packaging configuration.

Which active ingredient combinations and comparator arms show up in trials?

No trial-level mapping to the exact product configuration is available.

Are there phase 3 or pivotal efficacy/safety studies for this specific formulation?

No validated phase 3/pivotal dataset is available.

What is the current FDA status of Dextrose 5% in Acetated Ringer’s in plastic container?

No product-specific FDA status record is available for this exact presentation (strength, container type, label).

What is the Orange Book listing for this product?

No Orange Book listing can be tied to the exact presentation.

Is the product approved under NDA, ANDA, or 505(b)(2)?

No assignable application pathway can be identified for this specific configuration.

How many patents protect Dextrose 5% in Acetated Ringer’s in a plastic container?

No patent estate can be generated for this exact presentation.

What patents protect the composition, method of use, and manufacturing for this drug?

No assignable composition, process, or use patents can be tied to the exact product.

Where are the filing and expiration dates for relevant patents?

No expiration timeline can be produced.

When does exclusivity end for this Dextrose 5% in Acetated Ringer’s product?

No exclusivity end date can be produced because the product’s regulatory and exclusivity record cannot be uniquely identified.

What is the market size for Dextrose 5% in Acetated Ringer’s in plastic containers, and how will it grow?

No presentation-specific market sizing can be produced because the product cannot be uniquely linked to a specific FDA listing, manufacturer segment, or NDC aggregation basis.

Which segment drives demand: hospital acute care, ED, surgery, or chronic settings?

No segment breakdown can be produced for this exact formulation.

What pricing and reimbursement dynamics apply to this specific product?

No product-specific pricing datasets are available to support a projection.

Which companies sell Dextrose 5% in Acetated Ringer’s in plastic containers in the US?

No reliably attributable competitor list can be produced for the exact presentation.

How many labelers compete for this configuration by NDC?

No NDC-to-labeler mapping is available.

What generic or biosimilar entry risks exist for this formulation?

This is a sterile IV fluid combination, where competitive entry is typically driven by ANDA/505(b)(2) and supplier capacity. However, no product-specific approval and patent status is available to evaluate entry risk.

Are there Paragraph IV challenges tied to this specific product?

No Paragraph IV dataset can be mapped to this presentation.

What settlements or injunctions affect launch timing?

No litigation/settlement records can be mapped.

How does this product compare with other IV fluids like D5W in water or D5% in normal saline?

A direct comparison cannot be completed at the formulation-and-market level because the exact product identification and usage basis are not available for this presentation.

What clinical role does it play versus D5W and balanced crystalloids?

No product-specific clinical evidence mapping is available.

Key Takeaways

• A complete clinical-trials update, FDA status review, patent/exclusivity analysis, and market projection cannot be produced for this exact presentation (Dextrose 5% in acetated Ringer’s in plastic container) because the underlying uniquely identifiable regulatory and record set cannot be established from available inputs.

FAQs

1. What indications are listed on US labeling for Dextrose 5% in acetated Ringer’s IV solution in plastic containers?
2. Does this formulation have any device or container-related change that affects stability, labeling, or recall risk?
3. Are there head-to-head trials comparing this combination to lactated Ringer’s, Plasma-Lyte, or normal saline regimens?
4. How do supply constraints for sterile IV fluids affect availability and pricing for this presentation?
5. What filing pathways (NDA vs ANDA vs 505(b)(2) vs BLA) are used by competitors for dextrose-and-balanced-crystalloid products?

References

(No sources cited because no uniquely attributable FDA/product, clinical-trials, or patent records were provided for this exact presentation.)