CLINICAL TRIALS PROFILE FOR RINGER'S IN PLASTIC CONTAINER

505(b)(2) Clinical Trials for Ringer's In Plastic Container

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT00968799 ↗	Hyperthermic Intraoperative Intraperitoneal Chemotherapy of Recurrent Ovarian Cancer - A Feasibility Study	Terminated	Cantonal Hospital of St. Gallen	N/A	2008-02-01	Most studies performing hyperthermic intraoperative intraperitoneal chemotherapy dose the cytotoxic drugs according to the body surface (like 50 mg/m² cisplatin) in analogy to systemic, intravenous chemotherapy (usually using the same dose). Although there seems to be a correlation between body surface and blood volume, the pharmacodynamics of drugs dosed by the body surface is still highly variable and thus dosing on the body surface is increasingly considered controversial for systemic administration. For hyperthermic intraoperative intraperitoneal chemotherapy dosing by the body surface makes even less sense, since the aim is the highest possible drug concentration in the peritoneum without undue local and systemic toxicity. Furthermore, most studies using intraoperative chemotherapy vary the volume of the perfusate according to the size of the patient. Since the amount of cytotoxic drug is already fixed by the dosing on the body surface (amount [mg] = dose [mg/m²] x body surface [m²]) the effective concentration (mg/l) in the perfusate can vary considerably between patients. On the other hand pharmacokinetic analyses have shown that reducing the concentration of the cytotoxic drug in the perfusate reduces the efficacy even if the amount of the drug remains the same. In this study the safety of a new dosing regime will be evaluated. The concentration of cisplatin in the perfusate will be held constant independent of body weight or size to achieve the highest effectiveness of the chemotherapy. The primary endpoint is the safety of the treatment. All patients should be able to receive full dose systemic carboplatin chemotherapy after completion the trial treatment.

All Clinical Trials for 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.
NCT00119184 ↗	Spinal Analgesia Versus No Analgesia: Study for External Cephalic Version	Terminated	Hadassah Medical Organization	Phase 1	2002-10-01	The purpose of this study is to examine whether spinal anesthesia affects the chances of successful external cephalic version (ECV) of a breech presenting fetus. Two study groups will be included; one will receive spinal anesthesia, the other will not. The non-spinal group will be permitted to cross over if ECV procedure is painful. The main outcome is success of ECV.
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.
NCT00273728 ↗	BaSES Trial: Basel Starch Evaluation in Sepsis	Completed	Fresenius AG	Phase 4	2005-05-01	Background: In patients with severe sepsis and septic shock early aggressive volume replacement reduced mortality. Standard infusion therapy consists of crystalloid infusions. The role of modern, low molecular weight, starch preparations and their influence on the course of disease is not determined yet. Hypothesis: The purpose of this study is to determine wether initial infusion therapy with Hydroxyethylstarch and Ringer's lactate reduces in septic patients reduces Intensive Care Unit and hospital length of stay without impairment of renal function Design: Double-blind, randomized, controlled monocentric study Setting: Intensive Care Units of a University Hospital Patients: 240 consecutive patients with sepsis, severe sepsis and septic shock Intervention: Volume therapy with Ringer's lactate and saline or hydroxy-ethyl starch (MW 130, substitution 0.4) in the first five days of intensive care treatment. Parameter: - Intensive Care length of stay - Hospital length of stay - Mortality - Kidney function Statistics: Mann-Whitney test for non-parametric data like intensive care length of stay. Unpaired t-Test for kidney function parameters. Study withdrawal: Significant impairment of kidney function parameters in the hydroxy-ethyl starch group

Clinical Trial Conditions for Ringer's In Plastic Container

Condition Name

Condition Name for Ringer's In Plastic Container
Intervention	Trials
Anesthesia	11
Hypotension	10
Postoperative Pain	7
Septic Shock	7

Condition MeSH

Condition MeSH for Ringer's In Plastic Container
Intervention	Trials
Hypotension	31
Hemorrhage	16
Pain, Postoperative	16
Pancreatitis	13

Clinical Trial Locations for Ringer's In Plastic Container

Trials by Country

Trials by Country for Ringer's In Plastic Container
Location	Trials
Egypt	79
United States	41
China	25
Canada	12
Indonesia	9

Trials by US State

Trials by US State for Ringer's In Plastic Container
Location	Trials
Pennsylvania	5
Illinois	4
California	4
Connecticut	3
Texas	3

Clinical Trial Progress for Ringer's In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Ringer's In Plastic Container
Clinical Trial Phase	Trials
Phase 4	83
Phase 3	33
Phase 2/Phase 3	12

Clinical Trial Status

Clinical Trial Status for Ringer's In Plastic Container
Clinical Trial Phase	Trials
Completed	147
Recruiting	52
Not yet recruiting	50

Clinical Trial Sponsors for Ringer's In Plastic Container

Sponsor Name

Sponsor Name for Ringer's In Plastic Container
Sponsor	Trials
Ain Shams University	16
Mansoura University	13
Kasr El Aini Hospital	12

Sponsor Type

Sponsor Type for Ringer's In Plastic Container
Sponsor	Trials
Other	401
Industry	42
U.S. Fed	1

Clinical Trials, Market Analysis, and Projections for Ringer's Injection in Plastic Containers

Introduction

Ringer's Injection, a sterile, nonpyrogenic solution, is widely used for fluid and electrolyte replenishment in medical settings. This article will delve into recent clinical trials, market analysis, and future projections for Ringer's Injection, particularly when packaged in plastic containers.

Clinical Trials and Safety

Recent Studies

A significant clinical trial to consider is the Albumin in Cardiac Surgery (ALBICS) trial, although it does not specifically focus on Ringer's Injection. However, it provides valuable insights into the use of fluid solutions in surgical contexts. The trial compared the safety and effectiveness of 4% albumin versus Ringer acetate as the priming solution for cardiopulmonary bypass and volume replacement in cardiac surgery patients. While the study did not find a significant difference in major adverse events between the two groups, it highlights the critical role of fluid management in surgical outcomes[1].

Safety and Efficacy of Ringer's Injection

Ringer's Injection is indicated as a source of water and electrolytes and is capable of inducing diuresis depending on the patient's clinical condition. It is a well-established solution with a long history of safe use. However, it is important to note that concomitant treatment with certain drugs, such as ceftriaxone, is contraindicated[4].

Market Analysis

Global Market Size and Growth

The global market for plastic containers, which includes those used for Ringer's Injection, is substantial and growing. The plastic containers market was valued at USD 207.35 billion in 2023 and is projected to grow to USD 344.79 billion by 2032, at a CAGR of 5.9% during the forecast period[5].

Segment Analysis

In the context of medical use, plastic containers for Ringer's Injection fall under the pharmaceuticals segment. This segment is driven by the increasing demand for safe, chemically inert, and corrosion-resistant containers. Polyethylene and polypropylene are key resins used in this sector due to their chemical inertness and resistance to corrosion, which are crucial for protecting medical products from chemicals and moisture[5].

Regional Insights

North America is a significant market for clinical trial packaging, including Ringer's Injection, due to its well-developed infrastructure and strong supply chain network. The region's stringent regulations by regulatory bodies like the FDA ensure that clinical trials follow strict safety protocols, which can impact the demand for high-quality packaging solutions[3].

Packaging and Regulatory Considerations

Packaging Materials

Ringer's Injection is often packaged in VIAFLEX plastic containers made from a specially formulated polyvinyl chloride (PL 146 Plastic). These containers are designed to ensure the solution's integrity and safety, with minimal leaching of chemical components like di-2-ethylhexyl phthalate (DEHP)[4].

Regulatory Compliance

The packaging of Ringer's Injection must comply with strict regulations set by regulatory bodies such as the FDA and Health Canada. These regulations ensure that the packaging is safe, easy to use, and properly labeled, which is critical for patient safety and the success of clinical trials[3].

Market Projections

Growth Drivers

The demand for Ringer's Injection and similar medical solutions is expected to grow due to several factors:

• Increasing Clinical Trials: The rise in the number of clinical trials, particularly in North America, will drive the demand for high-quality packaging solutions[3].
• Growing Pharmaceuticals Industry: The expansion of the pharmaceuticals industry, including the need for safe and reliable packaging, will continue to fuel the market[5].
• Advancements in Packaging Technology: Innovations in packaging, such as the integration of digital technology and customized packaging solutions, will create new opportunities for growth[3].

Challenges

Despite the growth potential, the market faces challenges such as high costs associated with clinical trials and stringent regulatory requirements. These factors can impact the profitability and efficiency of manufacturers and suppliers[3].

Key Takeaways

• Clinical Trials: Recent studies like the ALBICS trial highlight the importance of fluid management in surgical contexts, although they do not specifically focus on Ringer's Injection.
• Market Growth: The global market for plastic containers, including those used for Ringer's Injection, is projected to grow significantly, driven by the pharmaceuticals and food industries.
• Regulatory Compliance: Strict regulations ensure the safety and efficacy of Ringer's Injection packaging.
• Technological Advancements: Innovations in packaging technology will continue to drive market growth.

FAQs

What is Ringer's Injection used for?

Ringer's Injection is used as a source of water and electrolytes and is capable of inducing diuresis depending on the patient's clinical condition[4].

What type of packaging is typically used for Ringer's Injection?

Ringer's Injection is typically packaged in VIAFLEX plastic containers made from a specially formulated polyvinyl chloride (PL 146 Plastic)[4].

What are the key drivers of the market for Ringer's Injection packaging?

The key drivers include the increasing number of clinical trials, the growing pharmaceuticals industry, and advancements in packaging technology[3][5].

What are the main challenges faced by the market for Ringer's Injection packaging?

The main challenges include high costs associated with clinical trials and stringent regulatory requirements[3].

How is the global market for plastic containers expected to grow?

The global market for plastic containers is projected to grow from USD 218.04 billion in 2024 to USD 344.79 billion by 2032, at a CAGR of 5.9%[5].

Sources

1. JAMA Network: Effect of 4% Albumin Solution vs Ringer Acetate on Major Adverse Events in Patients Undergoing On-Pump Cardiac Surgery.
2. GlobeNewswire: US Food Storage Container Market Focused Insights 2024-2029.
3. GlobeNewswire: Clinical Trial Packaging Market Size Expected to Reach USD 9.12 Billion by 2034.
4. FDA: Ringer's Injection, USP - in VIAFLEX Plastic Container.
5. Fortune Business Insights: Plastic Containers Market Size, Share | Growth Report [2032].

Last updated: 2025-01-07