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NCT01438502 ↗	"The Effect of Reduced Fluid Load After Cardiac Surgery"	Withdrawn	Haukeland University Hospital		1969-12-31	The purpose of this study is to verify that an infusion of hypertonic saline/colloids during cardio-pulmonary-bypass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.

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
Acute Kidney Injury	1
Sepsis, Severe	1
Bowel Preparation	1
Septic Shock	1

Condition MeSH

Condition MeSH for Dextrose 5% In Acetated Ringer's In Plastic Container
Intervention	Trials
Shock, Septic	2
Coronary Disease	1
Toxemia	1
Coronary Artery Disease	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
China	1
Egypt	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	2
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	9

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

Introduction

Dextrose 5% in Lactated Ringer's Injection is a sterile, nonpyrogenic solution used for fluid and electrolyte replenishment, as well as caloric supply. This solution is widely used in clinical settings for various medical conditions. Here, we will delve into the current state of clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Safety Profile

Current Clinical Data

There are no adequate and well-controlled studies with Dextrose 5% in Lactated Ringer's Injection in pregnant women and animal reproduction studies. However, the solution has been extensively used in clinical practice, and its safety profile is well-documented through post-marketing reports and clinical experience.

Adverse Reactions

The solution can cause several adverse reactions, including hypersensitivity and infusion reactions such as angioedema, chest pain, bronchospasm, dyspnea, and urticaria. Other reported reactions include hyperglycemia, hyperosmolarity, osmotic diuresis, dehydration, electrolyte loss, and metabolic alkalosis with or without hypokalemia[2][3][4].

Special Populations

• Neonates and Infants: Lactate-containing solutions should be administered with caution to neonates and infants less than 6 months of age due to the risk of hyperglycemia and its associated complications.
• Geriatric Use: Dose selection for elderly patients should be cautious, starting at the low end of the dosing range, due to the greater frequency of decreased hepatic, renal, or cardiac function[2][3][4].

Market Analysis

Market Size and Growth

While the specific market size for Dextrose 5% in Lactated Ringer's Injection is not separately reported, it is part of the broader intravenous (IV) fluid therapy market. The global IV fluid market, including solutions like compound sodium acetate ringer injection, is experiencing significant growth. For instance, the compound sodium acetate ringer injection market is expected to grow from approximately USD 1.4 billion in 2023 to USD 2.4 billion by 2033, at a compound annual growth rate (CAGR) of 5.2%[5].

Key Drivers

• Increasing Demand for IV Fluid Therapy: The growing prevalence of chronic diseases, the rising number of surgical procedures, and the increasing incidence of dehydration and electrolyte disorders are key factors driving the market growth.
• Clinical Settings: The solution is commonly used in hospital settings, particularly in critical care, surgery, and emergency departments[5].

Packaging and End-User Segments

• Packaging: The 500 mL packaging segment currently dominates the market, but the 1000 mL segment is expected to witness the highest growth rate, driven by the increasing incidence of severe dehydration and complex surgical procedures.
• End Users: North America, particularly the United States, is the largest market, followed by Europe and the Asia-Pacific region. The latter is expected to witness the highest growth rate due to improving healthcare infrastructure and rising healthcare awareness[5].

Market Projections

Future Outlook

The market for Dextrose 5% in Lactated Ringer's Injection is expected to continue growing, driven by several factors:

• Rising Prevalence of Chronic Diseases: The increasing burden of chronic diseases will continue to drive the demand for IV fluid therapy.
• Expanding Healthcare Infrastructure: Improvements in healthcare infrastructure, especially in emerging markets, will support market growth.
• Advancements in Packaging and Delivery: The development of novel packaging and delivery systems, such as ready-to-use bags and pre-mixed solutions, will enhance the convenience and safety of administration, further driving market growth[5].

Challenges

Despite the positive outlook, the market will face challenges such as:

• Availability of Alternative IV Fluids: The presence of alternative IV fluids could impact market share.
• Potential for Adverse Reactions: The need for careful monitoring and management of potential adverse reactions will remain a critical factor.
• Storage and Handling: Proper storage and handling of the product will continue to be essential to ensure safety and efficacy[5].

Key Takeaways

• Clinical Use: Dextrose 5% in Lactated Ringer's Injection is a valuable solution for fluid and electrolyte replenishment and caloric supply, but it requires careful administration, especially in special populations.
• Market Growth: The market is expected to grow steadily, driven by increasing demand for IV fluid therapy and expanding healthcare infrastructure.
• Challenges: The market faces challenges related to adverse reactions, alternative products, and storage and handling requirements.

FAQs

What are the primary components of Dextrose 5% in Lactated Ringer's Injection?

The solution contains 5 g Dextrose Hydrous, 600 mg Sodium Chloride, 310 mg Sodium Lactate, 30 mg Potassium Chloride, and 20 mg Calcium Chloride per 100 mL[2][3][4].

What are the common adverse reactions associated with this solution?

Common adverse reactions include hypersensitivity and infusion reactions, hyperglycemia, hyperosmolarity, osmotic diuresis, dehydration, electrolyte loss, and metabolic alkalosis with or without hypokalemia[2][3][4].

How should this solution be used in special populations?

The solution should be used with caution in neonates, infants, and elderly patients due to potential complications such as hyperglycemia and impaired lactate metabolism[2][3][4].

What is the expected market growth for IV fluid therapy solutions like Dextrose 5% in Lactated Ringer's Injection?

The market is expected to grow at a CAGR of 5.2% from 2024 to 2033, driven by increasing demand for IV fluid therapy and expanding healthcare infrastructure[5].

What are the key challenges facing the market for this solution?

Challenges include the availability of alternative IV fluids, the potential for adverse reactions, and the need for proper storage and handling of the product[5].

Sources

1. FDA Label: Lactated Ringer's and 5% Dextrose Injection, USP[2].
2. FDA Label: Lactated Ringer's and 5% Dextrose Injection, USP[3].
3. Baxter Canada: Lactated Ringer's and 5% Dextrose Injection, USP[4].
4. Data Horizon Research: Compound Sodium Acetate Ringer Injection Market Size, Share[5].