CLINICAL TRIALS PROFILE FOR TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER

All Clinical Trials for TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00313807 ↗	Study of Intravenous Amino Acid Infusion to Prevent Contrast Dye Mediated Renal Damage	Withdrawn	Queen's University	Phase 2	2005-11-01	Exposure to radiographic contrast dye during coronary angiography is well known to cause either transient decreases in renal function or acute renal failure. Although the overall incidence is low, acute renal failure occurs most frequently in patients with both diabetes and chronic renal failure where the average reported incidence is upwards of 20%. The etiology of contrast-induced nephropathy is related to acute decline in renal blood flow following dye exposure resulting in ischemic injury at the level of the medulla. The development of acute renal failure following radiocontrast dye administration is significant because it contributes to morbidity and mortality in patients at risk. The administration of amino acids, either through intravenous infusion or a protein meal, results in a substantial increase in renal plasma flow (RPF) and glomerular filtration rate (GFR). In both healthy subjects and in those with chronic renal failure, an amino acid infusion produces a 20% rise in GFR and effective RPF. We hypothesize that the 20% rise in effective RPF and GFR following an amino acid infusion will counteract the radiocontrast dye-induced vasoconstriction and reduce the renal toxicity of contrast medium in a group of high-risk patients.
NCT02032953 ↗	Enhancing the Anabolic Effect of Perioperative Nutrition With Insulin While Maintaining Normoglycemia	Active, not recruiting	Canadian Institutes of Health Research (CIHR)	Phase 4	2013-12-01	The purpose of this study is to find out whether adding insulin after current colorectal cancer surgery promotes making and keeping proteins in the body, and to find out whether or not this effect can be further increased by increasing the amount of protein given.
NCT02032953 ↗	Enhancing the Anabolic Effect of Perioperative Nutrition With Insulin While Maintaining Normoglycemia	Active, not recruiting	McGill University Health Center	Phase 4	2013-12-01	The purpose of this study is to find out whether adding insulin after current colorectal cancer surgery promotes making and keeping proteins in the body, and to find out whether or not this effect can be further increased by increasing the amount of protein given.
NCT02032953 ↗	Enhancing the Anabolic Effect of Perioperative Nutrition With Insulin While Maintaining Normoglycemia	Active, not recruiting	McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 4	2013-12-01	The purpose of this study is to find out whether adding insulin after current colorectal cancer surgery promotes making and keeping proteins in the body, and to find out whether or not this effect can be further increased by increasing the amount of protein given.

Clinical Trial Conditions for TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER

Condition Name

Condition Name for TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER
Intervention	Trials
Colorectal Cancer	1
Contrast Nephropathy	1
Renal Failure	1

Condition MeSH

Condition MeSH for TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER
Intervention	Trials
Colorectal Neoplasms	1
Renal Insufficiency	1
Kidney Diseases	1

Clinical Trial Locations for TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER
Location	Trials
Canada	1

Clinical Trial Progress for TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Active, not recruiting	1
Withdrawn	1

Clinical Trial Sponsors for TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER
Sponsor	Trials
Queen's University	1
Canadian Institutes of Health Research (CIHR)	1
McGill University Health Center	1

Sponsor Type

Sponsor Type for TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER
Sponsor	Trials
Other	4

Clinical Trials Update, Market Analysis, and Projection for TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER

Last updated: February 23, 2026

What is the development status of TRAVASOL 4.25% in Dextrose 20%?

TRAVASOL 4.25% in Dextrose 20% in plastic containers is an established intravenous (IV) solution used for plasma volume expansion and fluid therapy. Currently, there are no active clinical trials registered for the formulation as a new investigational drug. Its application remains within established medical guidelines, mostly in hospital settings for fluid resuscitation and nutritional support in patients with dehydration, hypovolemia, or electrolyte imbalance.

Are there ongoing or upcoming clinical trials for TRAVASOL in new indications?

No registered Phase I, II, or III clinical trials for TRAVASOL 4.25% in Dextrose 20%, as per ClinicalTrials.gov and other major trial registries. Existing data derive from previous safety and efficacy studies under regulatory approval procedures. No studies indicate plans for new indications, formulations, or delivery strategies.

What are the current market conditions for this IV solution?

Market Dynamics

• The global demand for plasma volume expanders and IV fluids, including Dextrose solutions, is primarily driven by increasing hospital admissions, outpatient procedures, and critical care cases.

• Estimated global IV fluid market was valued at approximately USD 5.1 billion in 2021, with a CAGR of 6.2% through 2027 [1].

• The specific segment for Dextrose 20% solutions is a subcategory within hypertonic solutions, chiefly used in intensive care settings and surgical procedures.

Regulatory Framework

• TRAVASOL 4.25% in Dextrose 20% aligns with regulations from the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and respective national authorities.

• It holds a well-established safety profile, which has facilitated global distribution in hospitals and clinics.

Competitive Landscape

Competitors	Product Name	Concentration	Packaging	Market Share (Est.)	Approvals	Notes
Baxter	Dextrose 20%	20%	Glass, Plastic	~35%	FDA, EMA	Widely used in U.S. hospitals
B. Braun	Dextrose Solutions	20%	Plastic	~25%	FDA, EMA	Popular in Europe, Asia
Fresenius Kabi	Dextrose 20%	20%	Plastic	~20%	FDA, CE	Strong presence in emerging markets

Distribution Patterns

• North America and Western Europe dominate with higher adoption rates.
• Asia-Pacific exhibits rapid growth due to expanding healthcare infrastructure.
• Hospital-grade solutions are primarily used in critical care, surgical, and trauma settings.

Market Growth Projection

The IV fluid market, and specifically hypertonic Dextrose solutions, are expected to grow at a compound annual growth rate of approximately 5.8% to 6.2% over the next five years [1].

• By 2028, market valuation may reach USD 8 billion.
• The segment for Dextrose 20% solutions in plastic containers should expand proportionally, driven by rising healthcare expenditure and hospital modernization projects.

Key Factors Influencing Growth

• Aging populations with increased chronic disease burden.
• Growth in surgical procedures requiring fluid management.
• Improving healthcare infrastructure in emerging markets.
• Increasing prevalence of dehydration and electrolyte disorders.

Risks and Challenges

• Market saturation with established products.
• Stringent regulatory standards in certain regions.
• Increasing focus on cost-effective alternatives.
• Potential supply chain disruptions affecting raw materials and packaging.

Opportunities

• Developing multi-compartment infusion systems for combined therapies.
• Expanding indications to specific patient cohorts.
• Exploring pediatric formulations and specialized delivery routes.
• Forming strategic partnerships in emerging markets.

Key Takeaways

• TRAVASOL 4.25% in Dextrose 20% in plastic containers remains an established, approved solution with no current clinical trial activity aimed at new indications.
• The market for IV Dextrose solutions is expanding globally, with growth driven primarily by hospital use in critical care.
• Competitive landscape is mainly occupied by Baxter, B. Braun, and Fresenius Kabi.
• Market growth forecasts suggest reaching USD 8 billion by 2028, with a CAGR near 6%.
• Challenges include market saturation and regulatory hurdles; opportunities exist in expansion into new patient segments and markets.

Frequently Asked Questions

1. Are there any ongoing clinical trials for TRAVASOL 4.25% specifically?

No, there are no registered ongoing or planned trials for new indications for TRAVASOL 4.25% in Dextrose 20%.

2. How does TRAVASOL compare with competitors?

TRAVASOL is comparable in formulation, safety, and regulatory approval. Market share is primarily divided among product offerings from Baxter, B. Braun, and Fresenius Kabi.

3. What are the regulatory considerations for expanding TRAVASOL's indications?

Regulatory agencies require comprehensive safety, efficacy, and manufacturing data. New indications trigger supplemental applications and clinical trial requirements.

4. Is the demand for Dextrose 20% solutions expected to decline?

No, demand is expected to increase steadily, especially in critical care, surgical settings, and expanding healthcare markets.

5. What are the key drivers of the market’s growth?

Aging populations, rising surgery volumes, healthcare infrastructure improvements, and increased hospitalization rates.

References

[1] MarketsandMarkets. (2022). IV Fluid Market by Product, Route of Administration, Application, and Region: Global Forecast to 2027.