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

All Clinical Trials for Dextrose 5% And 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.
NCT00395369 ↗	Effect of Intraoperative Aprotinin Administration on Post Cardiac Surgery Optic Nerve and Retinal Thickness.	Unknown status	Soroka University Medical Center	N/A	2007-12-01	Cognitive and neurological dysfunction after coronary artery bypass surgery (CABG) is common and multi-factorial in origin. Several previous studies have shown that intraoperative aprotinin administration may be neuroprotective.in the current prospective randomized study, the effect of intraoperative aprotinin administration on the integrity of the optic nerve and retinal nerve fiber layer will be examined. Optical coherance tomography will be used to examin the optic nerve and retinal nerve fiber layer.

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

Condition Name

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

Condition MeSH

Condition MeSH for Dextrose 5% And Lactated Ringer's In Plastic Container
Intervention	Trials
Hypotension	16
Pancreatitis	11
Hemorrhage	10
Pain, Postoperative	8

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

Trials by Country

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

Trials by US State

Trials by US State for Dextrose 5% And Lactated Ringer's In Plastic Container
Location	Trials
Illinois	4
Pennsylvania	3
Connecticut	3
California	3
Minnesota	2

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

Clinical Trial Phase

Clinical Trial Phase for Dextrose 5% And Lactated Ringer's In Plastic Container
Clinical Trial Phase	Trials
Phase 4	39
Phase 3	14
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for Dextrose 5% And Lactated Ringer's In Plastic Container
Clinical Trial Phase	Trials
Completed	64
Not yet recruiting	29
Recruiting	26

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

Sponsor Name

Sponsor Name for Dextrose 5% And Lactated Ringer's In Plastic Container
Sponsor	Trials
Ain Shams University	9
Cairo University	6
Mansoura University	5

Sponsor Type

Sponsor Type for Dextrose 5% And Lactated Ringer's In Plastic Container
Sponsor	Trials
Other	214
Industry	17
NIH	2

Dextrose 5% and Lactated Ringer's in Plastic Container: Clinical Trials, Market Analysis, and Projections

Introduction

Dextrose 5% in Lactated Ringer's solution is a widely used intravenous fluid for replenishing electrolytes, providing calories, and maintaining fluid balance in patients. This article will delve into recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Recent Studies

A recent randomized controlled trial compared the effects of 5% Dextrose in Ringer's Lactate (RLD5) versus 5% Dextrose Normal Saline (DNS) in non-critically ill children. The study, conducted between August 2021 and July 2022, enrolled 71 children in each group. Key findings included:

• Serum Chloride Levels: There was a statistically significant difference in serum chloride levels between the two groups, although this difference was clinically insignificant[1].
• Hyperchloremic Metabolic Acidosis (HCMA): The incidence of HCMA was higher in the DNS group at 24 hours (14%) and 48 hours (4.2%) compared to the RLD5 group (2.8% at both time points)[1].
• Acute Kidney Injury (AKI): The incidence of AKI was low in both groups, with no significant difference observed[1].

Safety and Efficacy

The solution is indicated as a source of water, electrolytes, and calories, and it produces a metabolic alkalinizing effect due to the lactate ions being metabolized to carbon dioxide and water[3][5].

Special Considerations

• Hyperglycemia: Solutions containing dextrose should be used cautiously in patients with impaired glucose tolerance or diabetes, as they can lead to hyperglycemia. This is particularly relevant in patients with conditions like severe traumatic brain injury or acute ischemic strokes[2][3].
• Pregnancy and Geriatric Use: There are no adequate and well-controlled studies in pregnant women, and the drug should be used only if clearly needed. For elderly patients, dose selection should be cautious due to potential decreased renal function[4].

Market Analysis

Current Market

The market for intravenous fluids, including Dextrose 5% in Lactated Ringer's, is driven by the increasing demand for fluid and electrolyte replenishment in various clinical settings. The solution's versatility in providing both electrolytes and calories makes it a staple in many hospitals and healthcare facilities.

Key Players

Major pharmaceutical companies such as Baxter and other manufacturers of intravenous solutions are key players in this market. These companies invest heavily in research and development to ensure the quality and safety of their products.

Market Trends

• Increasing Demand: The demand for intravenous fluids is expected to rise due to the growing number of hospital admissions and surgical procedures.
• Technological Advancements: Improvements in packaging, such as the use of plastic containers, have enhanced the safety and convenience of these solutions. For example, the Viaflex plastic container used for Lactated Ringer's and 5% Dextrose Injection is designed to be sterile and nonpyrogenic, with minimal leaching of chemical components into the solution[2][3].

Market Projections

Growth Forecast

The market for intravenous fluids is projected to grow steadily over the next few years, driven by increasing healthcare needs and advancements in medical technology. The global intravenous solutions market is expected to expand due to the rising incidence of chronic diseases and the need for fluid and electrolyte management.

Regional Analysis

• North America and Europe: These regions are expected to remain significant markets due to their well-established healthcare systems and high demand for intravenous fluids.
• Asia-Pacific: This region is anticipated to show rapid growth due to increasing healthcare expenditure and a growing patient population.

Competitive Landscape

Product Differentiation

Dextrose 5% in Lactated Ringer's solution differentiates itself through its balanced electrolyte composition and the metabolic alkalinizing effect of lactate. This makes it a preferred choice in many clinical scenarios.

Regulatory Environment

The regulatory environment plays a crucial role in the market for intravenous fluids. Manufacturers must comply with strict safety and efficacy standards set by regulatory bodies such as the FDA. The lack of adequate and well-controlled studies in certain populations, like pregnant women, can impact market dynamics[4].

Key Takeaways

• Clinical Significance: Recent clinical trials highlight the safety and efficacy of Dextrose 5% in Lactated Ringer's solution, although some differences in serum chloride levels and incidence of HCMA were noted.
• Market Demand: The market for intravenous fluids is expected to grow due to increasing healthcare needs and technological advancements.
• Regulatory Compliance: Manufacturers must adhere to strict regulatory standards to ensure the safety and efficacy of their products.
• Special Considerations: The solution should be used cautiously in patients with hyperglycemia risks or impaired renal function.

FAQs

Q: What are the primary components of Dextrose 5% in Lactated Ringer's solution?

A: Each 100 mL of the solution contains 5 g of dextrose, 600 mg of sodium chloride, 310 mg of sodium lactate, 30 mg of potassium chloride, and 20 mg of calcium chloride[5].

Q: What are the potential risks associated with using Dextrose 5% in Lactated Ringer's solution in patients with diabetes?

A: The solution can lead to hyperglycemia, which is particularly concerning in patients with diabetes or impaired glucose tolerance. This can exacerbate conditions like cerebral ischemic brain damage and impair recovery after acute ischemic strokes[2][3].

Q: Can Dextrose 5% in Lactated Ringer's solution be used in pregnant women?

A: The solution should be used in pregnant women only if clearly needed, as there are no adequate and well-controlled studies to determine its safety in this population[4].

Q: How does the lactate in Dextrose 5% in Lactated Ringer's solution affect the body?

A: The lactate ions are metabolized to carbon dioxide and water, which requires the consumption of hydrogen cations, thereby producing a metabolic alkalinizing effect[3][5].

Q: What are the potential adverse reactions associated with Dextrose 5% in Lactated Ringer's solution?

A: Adverse reactions may include febrile response, infection at the site of injection, venous thrombosis, phlebitis, extravasation, and hypervolemia[4].

Sources

1. PubMed: "5% Dextrose in Ringer's Lactate versus 5% Dextrose Normal Saline in Non-Critically Ill Children: A Randomized Controlled Trial."
2. Baxter: "Lactated Ringer's and 5% Dextrose Injection, USP In Viaflex Plastic Container."
3. DailyMed: "Lactated Ringer's and 5% Dextrose Injection, USP in VIAFLEX."
4. FDA: "NDA 19-634/S-021 Page 3 - 5% Dextrose in Lactated Ringer's Injection."
5. Drugs.com: "Dextrose in Lactated Ringer's: Package Insert / Prescribing Info."

Last updated: 2025-01-02