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

505(b)(2) Clinical Trials for Dextrose 5% In 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 Dextrose 5% In 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
NCT00273728 ↗	BaSES Trial: Basel Starch Evaluation in Sepsis	Completed	University Hospital, Basel, Switzerland	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
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.

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

Condition Name

Condition Name for Dextrose 5% In Ringer's In Plastic Container
Intervention	Trials
Anesthesia	11
Hypotension	10
Septic Shock	7
Cesarean Section	7

Condition MeSH

Condition MeSH for Dextrose 5% In Ringer's In Plastic Container
Intervention	Trials
Hypotension	31
Hemorrhage	16
Pain, Postoperative	16
Pancreatitis	13

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

Trials by Country

Trials by Country for Dextrose 5% In 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 Dextrose 5% In Ringer's In Plastic Container
Location	Trials
Pennsylvania	5
Illinois	4
California	4
Connecticut	3
Texas	3

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

Clinical Trial Phase

Clinical Trial Phase for Dextrose 5% In 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 Dextrose 5% In Ringer's In Plastic Container
Clinical Trial Phase	Trials
Completed	147
Recruiting	52
Not yet recruiting	50

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

Sponsor Name

Sponsor Name for Dextrose 5% In Ringer's In Plastic Container
Sponsor	Trials
Ain Shams University	16
Mansoura University	13
Kasr El Aini Hospital	12

Sponsor Type

Sponsor Type for Dextrose 5% In Ringer's In Plastic Container
Sponsor	Trials
Other	401
Industry	42
U.S. Fed	1

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

Introduction

Dextrose 5% in Ringer's solution is a widely used intravenous fluid for fluid and electrolyte replenishment, as well as caloric supply. This article will delve into recent clinical trials, market analysis, and future projections for this medication.

Clinical Trials Update

Recent Study on Serum Chloride Levels and Electrolyte Balance

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 aimed to estimate the difference in serum chloride levels and the incidence of hyperchloremic metabolic acidosis (HCMA), acute kidney injury (AKI), and all-cause mortality between the two groups.

• Key Findings:
  • The study revealed a statistically significant difference in serum chloride levels between the two groups at 24 and 48 hours, although this difference was clinically insignificant[1].
  • The incidence of HCMA was higher in the DNS group compared to the RLD5 group at both 24 and 48 hours.
  • There were no mortalities in either group, and the incidence of AKI was low and not significantly different between the groups[1].

Composition and Clinical Pharmacology

Components and Function

Dextrose 5% in Ringer's solution contains dextrose, sodium chloride, sodium lactate, potassium chloride, and calcium chloride. This solution serves as a source of water, electrolytes, and calories, and it can induce diuresis depending on the patient's clinical condition. The lactate ions in the solution produce a metabolic alkalinizing effect by being metabolized into carbon dioxide and water, which consumes hydrogen ions[3][4][5].

Indications and Usage

This solution is indicated for use in adult and pediatric patients as a source of electrolytes, calories, and water for hydration. It is particularly useful in scenarios requiring fluid and electrolyte replenishment and caloric supply[4][5].

Market Analysis

Market Size and Growth

The global market for 5% Dextrose Injection has experienced significant growth in recent years. As of 2023, the market size was substantial, and it is projected to continue growing through 2031. The market is segmented by type (250 mL, 500 mL, 1000 mL) and application (first-aid treatment, sports, trophotherapy, and others), with geographical regions also playing a crucial role in market dynamics[2].

Market Drivers and Challenges

• Drivers: The increasing demand for intravenous fluids in various medical settings, including emergency care, sports medicine, and general hospital use, is driving the market growth.
• Challenges: The market faces challenges such as the need for strict quality control, regulatory compliance, and the potential for adverse reactions, which can impact market dynamics[2].

Market Projections

Forecasted Growth

The 5% Dextrose Injection Market is expected to exhibit robust growth rates from 2023 to 2031. This growth is attributed to the increasing need for fluid and electrolyte replenishment in healthcare settings, coupled with advancements in medical technology and the expanding healthcare infrastructure in various regions[2].

Geographical Trends

The market is expected to grow significantly in regions such as North America, Europe, and the Asia-Pacific, driven by the increasing healthcare expenditure and the rising incidence of conditions requiring intravenous fluid therapy[2].

Safety and Precautions

Adverse Reactions

Post-marketing adverse reactions to Dextrose 5% in Ringer's solution include hypersensitivity/infusion reactions, infusion site reactions, and other manifestations such as angioedema, chest pain, and bronchospasm. Caution is advised in patients with impaired glucose tolerance or diabetes mellitus due to the potential for hyperglycemia[3][4][5].

Special Populations

• Pediatric Use: While the safety and effectiveness in pediatric patients have not been established by adequate and well-controlled trials, the solution is used in pediatric care with careful monitoring.
• Geriatric Use: Dose selection for elderly patients should be cautious, starting at the low end of the dosing range due to potential decreased hepatic, renal, or cardiac function[4].

Key Takeaways

• Clinical Trials: Recent trials highlight the differences in serum chloride levels and electrolyte balance between RLD5 and DNS, with no significant clinical impact.
• Market Analysis: The global market for 5% Dextrose Injection is growing, driven by increasing healthcare needs and technological advancements.
• Projections: The market is expected to continue its robust growth through 2031, with significant expansion in various geographical regions.
• Safety and Precautions: The solution is generally safe but requires caution in patients with glucose intolerance or diabetes and in special populations such as pediatrics and geriatrics.

FAQs

What is the primary use of Dextrose 5% in Ringer's solution?

The primary use of Dextrose 5% in Ringer's solution is as a source of water, electrolytes, and calories for hydration in adult and pediatric patients.

What are the key components of Dextrose 5% in Ringer's solution?

The solution contains dextrose, sodium chloride, sodium lactate, potassium chloride, and calcium chloride.

What were the findings of the recent clinical trial comparing RLD5 and DNS?

The trial found a statistically significant difference in serum chloride levels between the two groups, although this was clinically insignificant. The incidence of HCMA was higher in the DNS group.

What is the projected market growth for 5% Dextrose Injection?

The market is expected to exhibit robust growth from 2023 to 2031, driven by increasing healthcare needs and technological advancements.

What precautions should be taken when using Dextrose 5% in Ringer's solution in patients with diabetes?

The solution should be used with caution in patients with impaired glucose tolerance or diabetes mellitus due to the potential for hyperglycemia.

Sources

1. 5% Dextrose in Ringer's Lactate versus 5% Dextrose Normal Saline... - PubMed
2. Global 5% Dextrose Injection Market Size, Scope And Forecast Report - Market Research Intellect
3. Lactated Ringer's and 5% Dextrose Injection, USP - FDA
4. Dextrose in Ringer's: Package Insert / Prescribing Info - Drugs.com
5. Lactated Ringer's and 5% Dextrose Injection, USP In Viaflex Plastic Container - Baxter Canada