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Last Updated: February 8, 2025

CLINICAL TRIALS PROFILE FOR DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER


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All Clinical Trials for Dextrose 2.5% In Half-strength Lactated 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.
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.
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.
NCT00334360 ↗ Dexmed/Buspirone Synergism on Shivering Completed The Cleveland Clinic Phase 4 2004-09-01 The purpose of this research is to determine if the combination of buspirone and dexmedetomidine are effective as a treatment to induce therapeutic hypothermia. The design of the study includes four study days done in random order. The days are as follows: 1) Control (no drug); 2) Buspirone 60 mg orally; 3) Dexmedetomidine (delivered by a computer-controlled IV infusion to a target plasma concentration of 0.6 ng/ml); and, 3) the combination of buspirone 60 mg and dexmedetomidine (target plasma concentration of 0.6 ng/ml). a 20 cm-long catheter will be inserted into a cubital vein using standard aseptic technique In addition to the PIC line catheter, a simple peripheral catheter will be inserted into the other arm for drug administration. Throughout the study period, mean-skin temperature will be maintained at 31°C by adjusting the temperature of circulating water (Cincinnati Sub-Zero, Cincinnati, OH) and forced-air warmers (Augustine Medical, Inc., Eden Prairie, MN). Furthermore, the back, upper-body, and lower-body will individually be maintained at the designated skin temperature. Lactated Ringer's solution cooled to ≈3°C will be infused via the PIC-line at rates sufficient to decrease tympanic membrane temperature ≈1.5°C/h. Fluid will be administered as long as oxygen consumption or electromyographic intensity (see below) continues to increase or a total of 5 liters of fluid is given. Heart rate will be measured continuously using an electrocardiogram; blood pressure will be determined oscillometrically at 5 min intervals at the ankle. In case heart rate and/or blood pressure changes unexpectedly (by more than 30% of the baseline), the study will stop and the volunteer will be re-warmed immediately.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Dextrose 2.5% In Half-strength Lactated Ringer's In Plastic Container

Condition Name

Condition Name for Dextrose 2.5% In Half-strength Lactated Ringer's In Plastic Container
Intervention Trials
Anesthesia 5
Cesarean Section 4
Hypotension 4
Post-ERCP Acute Pancreatitis 4
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Condition MeSH

Condition MeSH for Dextrose 2.5% In Half-strength Lactated Ringer's In Plastic Container
Intervention Trials
Hypotension 16
Pancreatitis 11
Hemorrhage 10
Pain, Postoperative 8
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Clinical Trial Locations for Dextrose 2.5% In Half-strength Lactated Ringer's In Plastic Container

Trials by Country

Trials by Country for Dextrose 2.5% In Half-strength Lactated Ringer's In Plastic Container
Location Trials
Egypt 37
United States 33
China 12
Korea, Republic of 5
Brazil 4
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Trials by US State

Trials by US State for Dextrose 2.5% In Half-strength Lactated Ringer's In Plastic Container
Location Trials
Illinois 4
Pennsylvania 3
Connecticut 3
California 3
Minnesota 2
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Clinical Trial Progress for Dextrose 2.5% In Half-strength Lactated Ringer's In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Dextrose 2.5% In Half-strength Lactated Ringer's In Plastic Container
Clinical Trial Phase Trials
Phase 4 39
Phase 3 14
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for Dextrose 2.5% In Half-strength Lactated Ringer's In Plastic Container
Clinical Trial Phase Trials
Completed 64
Not yet recruiting 29
Recruiting 26
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Clinical Trial Sponsors for Dextrose 2.5% In Half-strength Lactated Ringer's In Plastic Container

Sponsor Name

Sponsor Name for Dextrose 2.5% In Half-strength Lactated Ringer's In Plastic Container
Sponsor Trials
Ain Shams University 9
Cairo University 6
Mansoura University 5
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Sponsor Type

Sponsor Type for Dextrose 2.5% In Half-strength Lactated Ringer's In Plastic Container
Sponsor Trials
Other 214
Industry 17
NIH 2
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Dextrose 2.5% In Half-strength Lactated Ringer's In Plastic Container: Clinical Trials, Market Analysis, and Projections

Introduction

Dextrose 2.5% in half-strength Lactated Ringer's solution is a critical intravenous fluid used for fluid and electrolyte replenishment, as well as providing caloric support. This article delves into the clinical trials, market analysis, and future projections for this formulation.

Clinical Trials and Safety Profile

Clinical Use and Indications

Dextrose 2.5% in half-strength Lactated Ringer's solution is indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with minimal carbohydrate calories. It is particularly useful in clinical conditions requiring fluid resuscitation, electrolyte balance, and caloric support[3][5].

Safety and Adverse Reactions

Clinical trials and post-marketing data indicate that this solution is generally safe when used as directed. However, potential adverse reactions include hypersensitivity/infusion reactions, such as anaphylactic/anaphylactoid reactions, infusion site reactions, and other symptoms like angioedema, chest pain, and dyspnea. Special caution is advised in patients with conditions associated with increased lactate levels or impaired lactate utilization, such as severe hepatic insufficiency[2][5].

Regulatory Compliance

The solution must comply with stringent regulatory norms set by bodies like the U.S. FDA and EMA. The safety of the plastic containers, such as those made from polyvinyl chloride (PVC), has been confirmed through USP biological tests and tissue culture toxicity studies[2][5].

Market Analysis

Global Market Size and Growth

The global lactated Ringer's injection market, which includes formulations like Dextrose 2.5% in half-strength Lactated Ringer's, is projected to grow significantly. The market is estimated to be valued at USD 510.1 million in 2024 and is expected to reach USD 762.2 million by 2031, with a compound annual growth rate (CAGR) of 5.9% from 2024 to 2031[1].

Market Segments

  • Formulation: The standard lactated Ringer’s solution segment, which includes half-strength formulations, is expected to contribute the highest market share, with 52.1% in 2024, due to its widespread acceptance among medical professionals[1].
  • Volume: The 250 ml segment is anticipated to contribute the highest share in terms of volume, with 48.1% in 2024, driven by high demand from outpatient settings[1].
  • Age Group: Adults are expected to contribute the highest share, with 38.12% in 2024, due to the large population base and higher occurrences of conditions requiring fluid resuscitation[1].

Regional Dominance

  • North America: This region dominates the market with a share of 40.2% in 2024, attributed to a well-established healthcare infrastructure and favorable reimbursement policies[1].
  • Asia Pacific: This region is expected to exhibit the fastest growth, driven by increasing medical expenditures, rising instances of chronic diseases, and the expansion of international players into emerging countries[1].

Market Drivers

Rising Prevalence of Chronic Diseases

The increasing prevalence of chronic diseases globally is a significant driver for the demand of lactated Ringer's solutions, including Dextrose 2.5% in half-strength formulations. These conditions often require fluid and electrolyte replacement, contributing to market growth[1].

Increasing Number of Surgeries

The high frequency of surgical procedures worldwide, particularly in countries like the U.S., amplifies the demand for intravenous fluids. Over 50 million surgical procedures are performed annually in the U.S., further driving the market[1].

Growing Healthcare Expenditure

Increased healthcare expenditure and growing awareness about fluid management are additional factors supporting the growth of the global lactated Ringer's injection market[1].

Market Opportunities

Expansion of Healthcare Infrastructure in Emerging Markets

The growing healthcare infrastructure in emerging economies presents lucrative opportunities for suppliers of lactated Ringer's solutions. Countries like India, China, and Brazil are investing heavily in strengthening hospital facilities and expanding medical services, generating substantial demand for intravenous fluids[1].

Government Investment and Regulatory Support

Government investments in healthcare and evidence-based care practices in countries like Canada also contribute to market growth. However, manufacturers must navigate complex regulatory guidelines set by bodies like the U.S. FDA and EMA[1].

Key Takeaways

  • The global lactated Ringer's injection market, including Dextrose 2.5% in half-strength formulations, is expected to grow significantly, driven by rising chronic diseases, increasing surgeries, and growing healthcare expenditure.
  • The standard lactated Ringer’s solution segment and 250 ml volume segment are expected to dominate the market.
  • North America currently leads the market, while the Asia Pacific region is expected to exhibit the fastest growth.
  • Emerging markets offer substantial opportunities due to expanding healthcare infrastructure.

FAQs

What is the primary use of Dextrose 2.5% in half-strength Lactated Ringer's solution?

The primary use is for parenteral replacement of extracellular losses of fluid and electrolytes, with minimal carbohydrate calories, and to provide caloric support.

What are the key drivers of the global lactated Ringer's injection market?

Key drivers include the rising prevalence of chronic diseases, increasing number of surgeries, and growing healthcare expenditure.

Which region is expected to exhibit the fastest growth in the lactated Ringer's injection market?

The Asia Pacific region is expected to exhibit the fastest growth due to growing medical expenditures and rising instances of chronic diseases.

What are the potential adverse reactions associated with Dextrose 2.5% in half-strength Lactated Ringer's solution?

Potential adverse reactions include hypersensitivity/infusion reactions, infusion site reactions, and other symptoms like angioedema and dyspnea.

What regulatory bodies oversee the approval of lactated Ringer's solutions?

Regulatory bodies such as the U.S. FDA and EMA oversee the approval process, which involves extensive clinical testing and documentation.

Sources

  1. Coherent Market Insights: Lactated Ringers Injection Market - Report, Trends, Share & Insights
  2. FDA: Lactated Ringer's and 5% Dextrose Injection, USP
  3. Drugs.com: Dextrose in Lactated Ringer's: Package Insert / Prescribing Info
  4. PharmaCompass: DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER-4
  5. Baxter: Lactated Ringer's and 5% Dextrose Injection, USP In Viaflex Plastic Container

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