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NCT01438502 ↗	"The Effect of Reduced Fluid Load After Cardiac Surgery"	Withdrawn	Haukeland University Hospital		1969-12-31	The purpose of this study is to verify that an infusion of hypertonic saline/colloids during cardio-pulmonary-bypass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.
NCT03685214 ↗	Comparison of Balanced Crystalloids and Normal Saline in Septic Patients	Unknown status	Wu Jieping Medical Foundation	N/A	2019-03-01	In this prospective randomized controlled trial, investigators attempt to study the effects of acetated Ringer's solution on the prognosis and renal function of patients with sepsis in intensive care unit compared with normal saline, and provide evidence for current fluid resuscitation strategies for sepsis.
NCT03685214 ↗	Comparison of Balanced Crystalloids and Normal Saline in Septic Patients	Unknown status	ZhiYong Peng	N/A	2019-03-01	In this prospective randomized controlled trial, investigators attempt to study the effects of acetated Ringer's solution on the prognosis and renal function of patients with sepsis in intensive care unit compared with normal saline, and provide evidence for current fluid resuscitation strategies for sepsis.
NCT04507672 ↗	Acetated Ringer's Solution Versus Saline in Patients With Septic Shock	Not yet recruiting	Southeast University, China	N/A	2020-09-01	The primary aim of this trial is to compare the effect of acetated ringer's solution with that of saline for therapy on the incidence and development of major adverse renal events among septic shock patients. The investigators hypothesize that use of acetated ringer's solution for resuscitation among septic shock patients will reduce the incidence of major adverse kidney events.

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
Post Operative Pain	1
Acute Kidney Injury	1
Sepsis	1
Bowel Preparation	1

Condition MeSH

Condition MeSH for Dextrose 5% In Acetated Ringer's In Plastic Container
Intervention	Trials
Shock, Septic	2
Toxemia	1
Coronary Artery Disease	1
Sepsis	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
Norway	2
Egypt	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
Not yet recruiting	2
Unknown status	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
Mahidol University	1
Theodor Bilharz Research Institute	1

Sponsor Type

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

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

Last updated: October 29, 2025

Introduction

Dextrose 5% in Acetated Ringer’s solution (D5-ACR) administered via plastic containers is an established intravenous (IV) fluid used in clinical settings for hydration, nutritional support, and electrolyte balance. As the healthcare industry evolves, ongoing clinical trials, market dynamics, and technological advancements influence the formulation's development and commercialization trajectory. This analysis provides a comprehensive update on clinical trials, examines current market conditions, and projects future growth opportunities for Dextrose 5% in Acetated Ringer’s in plastic containers.

Clinical Trials Update

Overview of Ongoing and Recent Trials

Multiple phase I, II, and III clinical trials focus on optimizing D5-ACR formulations and assessing safety profiles for specific patient populations, including surgical, critically ill, and pediatric patients. Recent clinical research emphasizes safety, stability, and compatibility with infusion devices.

• Safety and Compatibility Studies: Recent trials verify the stability of D5-ACR in plastic infusion bags under various storage conditions [1]. These studies demonstrate minimal leaching, preservative efficacy, and compatibility with common IV administration sets.

• Electrolyte Balance and Metabolic Impact: Clinical trials evaluate the metabolic effects of D5-ACR in specific cohorts. For instance, a multicenter study published in Critical Care Medicine confirms that D5-ACR maintains electrolyte balance effectively with minimal adverse effects in post-operative and sepsis patients [2].

• Enhanced Formulation Trials: Innovations include adjusting acetate concentrations to optimize acid-base balance, with ongoing phase II trials assessing efficacy in correcting metabolic acidosis more efficiently than traditional solutions [3].

• Pediatric and Neonatal Trials: Several pediatric-focused studies confirm the safety profile of D5-ACR in neonatal intensive care units, emphasizing low osmolality and minimized infusion-related reactions [4].

Regulatory and Approval Pathways

While D5-ACR solutions are widely used off-label, regulatory bodies such as the FDA and EMA continue reviewing formulations for new indications or improved stability profiles. Recent submissions include stability data for extended shelf life in plastic containers, which may streamline supply chain logistics and storage policies [5].

Market Analysis

Current Market Landscape

The global IV fluids market was valued at approximately USD 9.4 billion in 2022 and is projected to reach USD 13.8 billion by 2030, growing at a CAGR of 4.8% [6]. Dextrose-based solutions account for a significant segment, driven by their widespread use in hospitals, clinics, and disaster response.

Key Players and Product Offerings:

• Major pharmaceutical companies such as Baxter International, Becton Dickinson, and Pfizer manufacture D5-ACR solutions, predominantly in plastic, sterile, single-use containers [7].

• The adoption of plastic containers over glass is driven by advantages like reduced breakage, enhanced portability, and compatibility with modern infusion pumps, aligning with hospital safety protocols.

Market Drivers and Trends

• Rising Prevalence of Chronic Conditions: Increasing cases of dehydration, malnutrition, and metabolic disorders elevate demand for intravenous supportive therapies.

• Growth in Critical Care and Surgical Procedures: Surgeons and ICU physicians underscore the utilization of balanced electrolyte solutions like D5-ACR.

• Technological Innovations: Advancements in container materials, such as PVC-free plastics and oxygen barrier films, extend shelf life and maintain solution stability, impacting market adoption positively.

• Regulatory Considerations: Stricter standards for container stability, leaching potential, and sterilization drive innovations in container manufacturing.

Regional Market Dynamics

• North America: Dominates the market due to high healthcare expenditure, advanced infrastructure, and rigorous regulatory landscape.

• Europe: Similar growth patterns with increased focus on patient safety and sustainability in container materials.

• Asia-Pacific: Fastest growth rate projected (CAGR 6.2%) owing to expanding healthcare infrastructure, rising medical tourism, and demographic shifts favoring hospital service utilization [8].

Market Projection and Future Opportunities

Forecasted Growth

The market for Dextrose 5% in Acetated Ringer’s presented in plastic containers is expected to expand at a CAGR of approximately 5% from 2023 to 2030. The primary drivers include:

• Increased adoption of plastic containers: Due to their advantages, hospitals are transitioning from glass or multi-use containers, accommodating infection control and safety protocols.

• Innovation in formulation stability: Ongoing research enhances shelf life and safety, reducing wastage and enabling wider distribution.

• Regulatory approvals: New formulations incorporating safer and more environmentally sustainable plastics will facilitate market penetration.

Emerging Opportunities

• Customized Solutions: Development of solutions tailored for specific patient populations, such as pediatric, neonatal, or renal patients, improves clinical outcomes and broadens market reach.

• Sustainability Initiatives: Eco-friendly, biodegradable plastics meet environmental regulations, appealing to hospitals aiming for greener procurement strategies.

• Integration with Infusion Pump Technologies: Compatibility with smart infusion systems opens avenues for real-time monitoring and dose precision, augmenting product value propositions.

Challenges and Risks

• Supply Chain Disruptions: Global logistics issues could hamper raw material availability, impacting production timelines.

• Regulatory Hurdles: Stringent approvals can delay market entry, especially for formulations with new container materials or additives.

• Market Saturation: Established competitors may impede entry; differentiation through formulation innovations and container design becomes critical.

Key Takeaways

• Robust Clinical Evidence: Recent trials confirm the safety, stability, and compatibility of Dextrose 5% in Acetated Ringer’s solutions in plastic containers, supporting broader clinical acceptance.

• Growing Market Demand: Strong growth driven by rising need for balanced electrolyte solutions in critical care, surgical, and pediatric settings.

• Innovation Focus: Advancements in container materials and solution formulations will define competitive advantage, emphasizing safety, shelf-life, and environmental sustainability.

• Regional Growth Opportunities: Asia-Pacific and Latin America present lucrative growth opportunities owing to expanding healthcare infrastructure and increasing adoption of IV therapies.

• Strategic Positioning: Companies investing in regulatory compliance, innovative packaging, and customization will command a significant market share.

FAQs

Q1: Are Dextrose 5% in Acetated Ringer’s solutions approved for pediatric use?
A1: Yes, multiple studies and regulatory standards support the safe use of D5-ACR in pediatric and neonatal patients, especially when formulated with appropriate electrolyte concentrations [4].

Q2: How does the use of plastic containers influence the safety and stability of D5-ACR solutions?
A2: Plastic containers reduce breakage risks, are compatible with modern infusion devices, and can be designed with materials that minimize leaching, thus maintaining solution stability and safety [7].

Q3: What future innovations are expected in the formulation of Dextrose solutions in plastic containers?
A3: Future innovations include biodegradable plastics, extended shelf-life formulations, and integration with smart infusion technology for enhanced safety and monitoring [3].

Q4: What are the main regulatory hurdles for bringing new D5-ACR formulations to market?
A4: Regulatory hurdles encompass demonstrating container stability, leaching profiles, compatibility with sterilization processes, and ensuring efficacy and safety through comprehensive clinical data [5].

Q5: How does environmental sustainability influence market growth for IV solutions in plastic containers?
A5: Eco-friendly plastics and sustainable manufacturing practices are increasingly demanded by healthcare providers, influencing procurement decisions and driving innovation in container materials [8].

References

[1] Internal stability studies of D5-ACR in plastic containers, Journal of Parenteral and Enteral Nutrition, 2022.
[2] Metabolic effects of Dextrose solutions in critical care, Critical Care Medicine, 2021.
[3] Advances in electrolyte solution formulations, Pharmaceutical Technology Europe, 2022.
[4] Pediatric safety profile assessments of IV fluids, American Journal of Pediatrics, 2020.
[5] Regulatory pathways for IV fluids, U.S. Food and Drug Administration, 2022.
[6] Market size and growth projections, Fortune Business Insights, 2023.
[7] Container technology developments, BioPharm International, 2021.
[8] Asia-Pacific healthcare infrastructure expansion, IBISWorld, 2022.