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

505(b)(2) Clinical Trials for Dextrose 5% And 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% And 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.

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

Condition Name

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

Condition MeSH

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

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

Trials by Country

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

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

Clinical Trial Phase

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

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

Sponsor Name

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

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

Last updated: January 9, 2025

Introduction

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

Clinical Trials: Recent Findings

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 found a statistically significant difference in serum chloride levels between the two groups, although this difference was clinically insignificant. The incidence of hyperchloremic metabolic acidosis (HCMA) was higher in the DNS group, while acute kidney injury (AKI) rates were low and similar in both groups[1].

Rehydration in Hyperemesis Gravidarum

Another study compared 5% dextrose–Ringer’s lactate with Ringer’s lactate alone in the intravenous rehydration of women with grade II hyperemesis gravidarum. The results showed that both solutions effectively corrected electrolyte deficiencies and ketonuria, but the 5% dextrose–Ringer’s lactate group had a greater increase in blood potassium levels. However, this difference was not clinically significant[3].

Clinical Uses and Indications

Fluid and Electrolyte Replenishment

Dextrose 5% in Ringer's Lactate is indicated as a source of water, electrolytes, and calories. It is also used as an alkalinizing agent due to the metabolic effects of lactate, which is converted to bicarbonate in the body[2].

Contraindications and Precautions

The solution is contraindicated in patients with hypersensitivity to any of its ingredients or components of the container. It should be used with caution in patients with alkalosis, hypervolemia, or those at risk for hyperglycemia, especially in cases of diabetes or severe traumatic brain injury[2].

Market Analysis

Market Size and Growth

The global market for 5% Dextrose Injection has experienced significant growth and is projected to continue expanding from 2023 to 2031. The market size is anticipated to reach substantial values, driven by increasing demand in various segments such as first-aid treatment, sports, and trophotherapy[4].

Market Segmentation

The market is segmented based on type (250 mL, 500 mL, 1000 mL) and application (first-aid treatment, sports, trophotherapy, others), as well as geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). This segmentation helps in understanding the diverse needs and trends across different regions and applications[4].

Market Projections

Forecasted Growth

The 5% Dextrose Injection Market is expected to exhibit robust growth rates throughout the forecast period. The positive market dynamics, including drivers such as increasing healthcare needs and advancements in medical treatments, are expected to drive this growth. However, the market also faces challenges and restraints, such as regulatory hurdles and competition from alternative solutions[4].

Geographical Trends

The Asia-Pacific region is anticipated to be a significant contributor to the market growth due to the large population, increasing healthcare expenditure, and improving healthcare infrastructure. Other regions, such as North America and Europe, will also continue to play important roles in the market due to their established healthcare systems and high demand for intravenous solutions[4].

Key Considerations for Clinical Use

Geriatric Use

Clinical studies have not identified significant differences in responses between elderly and younger patients. However, dose selection for elderly patients should be cautious, starting at the lower end of the dosing range due to potential decreased hepatic, renal, or cardiac function[5].

Hyperglycemia Risk

Solutions containing dextrose should be used with caution in patients with impaired glucose tolerance or diabetes mellitus. The administration of dextrose can lead to hyperglycemia, which has been associated with poor outcomes in patients with severe traumatic brain injury[2].

Key Takeaways

• Clinical Trials: Recent studies highlight the efficacy of 5% Dextrose in Ringer's Lactate in maintaining electrolyte balance and correcting deficiencies, with some differences in outcomes compared to other solutions.
• Market Analysis: The global market for 5% Dextrose Injection is growing significantly, driven by increasing demand in various healthcare segments.
• Market Projections: The market is expected to continue its robust growth, with significant contributions from the Asia-Pacific region.
• Clinical Use: The solution is valuable for fluid and electrolyte replenishment but requires cautious use in certain patient groups, such as those with hyperglycemia risk or elderly patients.

FAQs

What are the primary indications for Dextrose 5% in Ringer's Lactate?

Dextrose 5% in Ringer's Lactate is indicated as a source of water, electrolytes, and calories, and also as an alkalinizing agent[2].

What are the key differences between RLD5 and DNS in clinical trials?

Clinical trials have shown that RLD5 and DNS have different effects on serum chloride levels and the incidence of hyperchloremic metabolic acidosis, though these differences are often clinically insignificant[1].

How does the market for 5% Dextrose Injection project to grow in the future?

The market is projected to exhibit robust growth rates from 2023 to 2031, driven by increasing demand in various healthcare segments and geographical regions[4].

What precautions should be taken when using Dextrose 5% in Ringer's Lactate in elderly patients?

Dose selection for elderly patients should be cautious, starting at the lower end of the dosing range due to potential decreased hepatic, renal, or cardiac function[5].

What are the potential risks associated with using dextrose-containing solutions in patients with diabetes?

The administration of dextrose can lead to hyperglycemia, which is particularly risky for patients with diabetes or those at risk for hyperglycemia, as it can worsen metabolic conditions and impair recovery in certain cases[2].

Sources

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