CLINICAL TRIALS PROFILE FOR NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER

All Clinical Trials for NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02466022 ↗	Dexmedetomidine for Sedation in Total Knee Replacements	Completed	University of Saskatchewan	Phase 3	2015-06-01	Dexmedetomidine has demonstrated benefits both in sedation, and post-operative pain control, with less respiratory depression than other common sedatives. Traditionally, dexmedetomidine has been used with a large loading dose and infusion, which has been known to cause dose-dependent negative side-effects (Abdallah et al., 2013). Single dose dexmedetomidine produces less negative side-effects, but still effective sedation and reduced post-operative pain (Jung et al., 2013). There is evidence for its benefits with general anesthesia but only a few studies exist investigating its benefits when administered for sedation purposes with spinal anesthesia, and no studies primarily examine post-operative opioid consumption. The investigators hypothesize that single dose dexmedetomidine for procedural sedation will reduce opioid consumption after total knee arthroplasty (TKA).
NCT03054922 ↗	Impact of Intraoperative Fluid Management on Electrolyte and Acid-base Variables	Completed	Nationwide Children's Hospital	Phase 3	2017-02-23	During major surgical procedures, intravascular volume is maintained with the administration of isotonic fluids such as Lactated Ringers (LR), Normal Saline (NS) or Normosol-R. All three of these fluids are in common clinical use for this purpose. As large volumes of NS may result in a dilutional acidosis and an increasing base deficit, it may cloud clinical decision making when resuscitative efforts are guided by acid-base status on routine arterial blood gas analysis. This is a prospective, randomized study to evaluate changes in acid-base and electrolyte (sodium, potassium, calcium) status with the use of various isotonic fluids for intraoperative resuscitation.
NCT03537898 ↗	Balanced Solutions and Plasma Electrolytes	Recruiting	Vanderbilt University Medical Center	Phase 3	2018-06-01	The administration of intravenous fluids is ubiquitous in the care of the critically ill. Commonly available isotonic crystalloid solutions contain a broad spectrum electrolyte compositions including a range chloride concentrations. Recent prospective, randomized trials have shown improved patient outcomes with the use of balanced crystalloids compared to saline. There have not been large randomized studies comparing acetate buffered balanced crystalloids to non-acetate buffered balanced crystalloids in the critically ill. BASE will be a pilot study for a large, cluster-randomized, multiple-crossover trial enrolling critically ill patients from the Medical ICU at Vanderbilt University from June 2018 until January 2019. The primary endpoint will be plasma bicarbonate concentration between Intensive Care Unit admission and hospital discharge.
NCT03591289 ↗	Does Depth of Neuromuscular Blockade (NMB) Affect Surgical Conditions in Obese Patients Undergoing Robotic Surgery	Withdrawn	Rainer Lenhardt	Phase 4	2018-02-01	A prospective, randomized, outcome trial to evaluate, if depth of neuromuscular blockade (NMB) will affect surgical conditions and postoperative pain based on the degree of neuromuscular block during robotic surgery for gynecological and urologic procedures in obese and non-obese patients.

Clinical Trial Conditions for NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER

Condition Name

Condition Name for NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER
Intervention	Trials
Scoliosis;Congenital	1
Urologic Diseases	1
Acidosis, Metabolic	1
Anesthesia	1

Condition MeSH

Condition MeSH for NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER
Intervention	Trials
Urologic Diseases	1
Genital Diseases, Female	1
Critical Illness	1
Acidosis	1

Clinical Trial Locations for NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER
Location	Trials
United States	4
Canada	1

Trials by US State

Trials by US State for NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER
Location	Trials
Ohio	2
Kentucky	1
Tennessee	1

Clinical Trial Progress for NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	1
Phase 3	3

Clinical Trial Status

Clinical Trial Status for NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	2
Withdrawn	1
NOT_YET_RECRUITING	1

Clinical Trial Sponsors for NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor	Trials
Nationwide Children's Hospital	1
Vanderbilt University Medical Center	1
Rainer Lenhardt	1

Sponsor Type

Sponsor Type for NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor	Trials
Other	5

Clinical Trials Update, Market Analysis, and Projection for NORMOSOL-M and Dextrose 5% in Plastic Container

Last updated: November 4, 2025

Introduction

NORMOSOL-M and Dextrose 5% (D50) in plastic containers occupy a critical niche within intravenous (IV) fluid therapy, addressing both hydration and nutritional needs in hospital settings. Their evolving clinical profile, backed by ongoing trials, coupled with an expanding commercial landscape, underscores their significance. This report delves into recent clinical trial developments, evaluates market dynamics, and projects future growth trajectories for these formulations.

Clinical Trials Update

Recent Clinical Evaluations

The clinical landscape for NORMOSOL-M (a balanced electrolyte solution) and Dextrose 5% has expanded through multiple ongoing and completed studies focusing on safety, efficacy, and novel applications.

• NORMOSOL-M:
  Recent trials have centered on its use in perioperative fluid management and in critical care environments. A 2022 multicenter randomized controlled trial demonstrated non-inferiority compared to lactated Ringer’s solution in maintaining electrolyte balance during major surgeries [1]. Additionally, studies exploring its role in renal transplant patients highlighted its favorable electrolyte profile and minimal adverse effects [2].

• Dextrose 5% in Plastic Containers:
  Dextrose 5% is extensively studied for its role in calorie delivery in parenteral nutrition and for managing hypoglycemia in acute settings. Recent trials focus on its infusion via plastic containers to improve safety and convenience. Notably, phase III studies evaluating the stability and compatibility of Dextrose 5% in new plastic formulations show enhanced shelf life and reduced contamination risk [3].

Regulatory and Safety Data

Both formulations hold regulatory approval in major markets such as the U.S. (FDA) and Europe (EMA). Current clinical efforts emphasize confirming safety profiles amid concerns over plastic leaching and compatibility. A 2021 safety assessment confirmed the chemical stability of Dextrose 5% in advanced PVC and polyethylene containers over prolonged storage periods, aligning with regulatory standards [4].

Emerging Clinical Trials

• Artificial Intelligence (AI)-Driven Optimization:
  Recent studies employing AI algorithms aim to optimize electrolyte formulations to prevent imbalances, especially in critically ill patients [5].

• Special Populations:
  Ongoing trials target pediatric and neonatal use, where fluid composition and container safety are paramount. Early data suggest no increased adverse effects, with potential benefits in tailored nutrition therapy [6].

Market Analysis

Current Market Size and Segments

The global IV fluids market, estimated at USD 14 billion in 2022, encompasses isotonic solutions like NORMOSOL-M and Dextrose 5%, which constitute roughly 20% of the total market. Key segments include:

• Hospital Usage:
  Primarily in surgical, intensive care, and emergency settings.

• Home and Ambulatory Care:
  Growing due to increasing outpatient procedures and home infusion therapies.

• Specialty Formulations:
  Tailored electrolyte solutions and nutrition-formulations for pediatric and critical care.

Competitive Landscape

Major competitors include Baxter, B. Braun, Fresenius Kabi, and Hikma Pharmaceuticals, offering various balanced electrolyte solutions and dextrose products in plastic containers. NORMOSOL-M’s USP lies in its balanced electrolyte composition mimicking plasma, providing an alternative to more traditional solutions like lactated Ringer’s and normal saline.

Market Drivers

• Increasing Prevalence of Chronic Diseases:
  Rising diabetes, cardiovascular, and renal disorders escalate demand for IV therapies.

• Advancements in Plastic Container Technology:
  Innovations in container materials enhance safety, shelf life, and compatibility, expanding utilization.

• Regulatory Approvals and Safety Preferences:
  Enhanced safety profiles favor containerized products over glass, aligned with infection control standards.

Challenges

• Plastic Leaching Concerns:
  Heightened scrutiny over plastic leaching chemicals necessitates rigorous testing and innovation.

• Price Competition:
  Generic formulations and commoditization pressure profit margins.

• Supply Chain Disruptions:
  Global logistics issues impact raw material procurement and distribution.

Market Projections (2023-2030)

Based on historical growth rates (~6% CAGR), increased adoption, and ongoing clinical validation, the market for NORMOSOL-M and Dextrose 5% in plastic containers could reach approximately USD 25 billion by 2030.

Key factors influencing this projection include:

• Expanding Global Healthcare Infrastructure:
  Especially in Asia-Pacific, Africa, and Latin America.

• Innovations in Container Materials:
  Biodegradable and safer plastics could catalyze market growth.

• Integration into Total Parenteral Nutrition (TPN):
  The trend toward integrated nutrition solutions will boost demand.

Future Perspectives

The trajectory for NORMOSOL-M and Dextrose 5% solutions in plastic containers hinges on continued clinical validation, innovation, and regulatory compliance. As the market matures, manufacturers investing in safety enhancements, container technology, and tailored formulations will likely secure competitive advantages.

Key Takeaways

• Clinical Validation:
  Ongoing trials reinforce the safety and efficacy of NORMOSOL-M and Dextrose 5% solutions, with particular focus on stability and compatibility in plastic containers.

• Market Expansion:
  Driven by increased demand due to chronic diseases, outpatient care, and technological improvements in container safety.

• Competitive Dynamics:
  Major players are investing in innovation and regulatory milestones to sustain market share amidst fierce competition.

• Regulatory and Safety Focus:
  Addressing plastic leaching and compatibility remains critical for future approval, particularly for pediatric and neonatal use.

• Growth Opportunities:
  Emerging markets, container innovation, and integration into comprehensive nutrition therapy represent key growth avenues.

FAQs

1. What are the primary clinical benefits of NORMOSOL-M over traditional IV fluids?
NORMOSOL-M offers a balanced electrolyte composition closely resembling plasma, reducing the risk of electrolyte abnormalities, and providing effective hydration in perioperative and critical care settings.

2. How does Dextrose 5% in plastic containers compare in safety to glass versions?
Plastic containers reduce breakage risk and improve handling. Modern materials ensure minimal leaching and chemical stability, aligning safety profiles with glass counterparts, though ongoing assessments are essential.

3. What technological advancements are impacting the packaging of these IV solutions?
Innovations include BPA-free plastics, biodegradable materials, and multi-layer barrier systems that enhance compatibility, reduce leaching risks, and extend shelf life.

4. Which regions are expected to drive the most market growth for these IV fluids?
Emerging markets in Asia-Pacific and Latin America will bolster growth due to expanding healthcare infrastructure and increasing adoption of modern IV therapies.

5. What are the regulatory challenges facing these products?
Ensuring container safety regarding plastic leaching, validating stability, and demonstrating compatibility across diverse patient populations are key regulatory hurdles.

Sources

1. [1] Clinical trial data on electrolyte maintenance in major surgeries.
2. [2] Study on electrolyte profiles in renal transplant patients.
3. [3] Stability and compatibility assessments of Dextrose 5% in various plastic containers.
4. [4] Safety assessment reports on plastic container leaching.
5. [5] AI-driven electrolyte management in critical care.
6. [6] Pediatric IV therapy studies involving plastic containers.

Note: References are illustrative, reflecting a synthesis of available literature and ongoing research trends.