CLINICAL TRIALS PROFILE FOR DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE

All Clinical Trials for DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00212043 ↗	Phase I/II Trial of Infusional Gemcitabine in Combination With Carboplatin in Chemonaive Non-small Cell Carcinoma	Completed	Eli Lilly and Company	Phase 2	2000-07-01	Hypothesis - Infusional gemcitabine may give better intracellular pharmacologic activation and be more effective clinically in non-small cell lung cancer
NCT00212043 ↗	Phase I/II Trial of Infusional Gemcitabine in Combination With Carboplatin in Chemonaive Non-small Cell Carcinoma	Completed	National University Hospital, Singapore	Phase 2	2000-07-01	Hypothesis - Infusional gemcitabine may give better intracellular pharmacologic activation and be more effective clinically in non-small cell lung cancer
NCT02294656 ↗	Acute Pseudophakic Cystoid Macular Edema Treatment Trial: Intravitreal Ranibizumab Versus Triamcinolone Acetonide	Completed	Genentech, Inc.	Phase 1	2014-11-01	This is an open-label, Phase I/II study evaluating intravitreal ranibizumab (R) vs. intravitreal Triesence (triamcinolone acetonide) (T) in subjects with acute pseudophakic cystoid macular edema (CME). Twenty consented patients with acute CME after phacoemulsification cataract surgery with posterior chamber intraocular lens implantation (PE/PCIOL) will be randomized 1:1 to treatment with R or T. R patients will receive three monthly R injections, followed by PRN dosing. T patients will receive PRN injections every 3 months. Clinical CME is defined as clinically evident CME, with visual acuity (VA) typically in the 20/40 to 20/200 range. Re-treatment criteria will include clinically evident worsening of CME, combined with any of the following: - Any increase in spectral domain ocular coherence tomography (OCT) central macular thickness (CMT) - Any observable fluid on OCT - Any qualitatively increased perifoveal leakage/pooling on fluorescein angiography (FA). Patients will be followed monthly through 12 months.
NCT02294656 ↗	Acute Pseudophakic Cystoid Macular Edema Treatment Trial: Intravitreal Ranibizumab Versus Triamcinolone Acetonide	Completed	Soll Eye	Phase 1	2014-11-01	This is an open-label, Phase I/II study evaluating intravitreal ranibizumab (R) vs. intravitreal Triesence (triamcinolone acetonide) (T) in subjects with acute pseudophakic cystoid macular edema (CME). Twenty consented patients with acute CME after phacoemulsification cataract surgery with posterior chamber intraocular lens implantation (PE/PCIOL) will be randomized 1:1 to treatment with R or T. R patients will receive three monthly R injections, followed by PRN dosing. T patients will receive PRN injections every 3 months. Clinical CME is defined as clinically evident CME, with visual acuity (VA) typically in the 20/40 to 20/200 range. Re-treatment criteria will include clinically evident worsening of CME, combined with any of the following: - Any increase in spectral domain ocular coherence tomography (OCT) central macular thickness (CMT) - Any observable fluid on OCT - Any qualitatively increased perifoveal leakage/pooling on fluorescein angiography (FA). Patients will be followed monthly through 12 months.
NCT02798757 ↗	Evaluation of the Tubular Effects of Dapagliflozin Using 1HNMR Spectroscopy	Completed	University of Ioannina	Phase 4	2016-06-01	This is a phase IV study that will explore the mechanisms of action of a drug (dapagliflozin) that is already commercially available in the country where the study will be conducted (Greece). The drug will be used according to its approved clinical indications (as add-on treatment in patients failed to achieve glycemic targets on metformin monotherapy) and in the approved posology (10 mg/day). Additionally, although there is limited data on the coadministration of dapagliflozin with thiazides, the excellent safety profile of the drug even when it is used in combination with drugs that induce significant volume depletion (such as loop diuretics) suggests that, in properly selected patients, the possibility of important adverse events during the coadministration of dapagliflozin with chlorthalidone is very low. All patients will give written informed consent prior to their enrollment in the study. The study protocol will be approved by the scientific committee of the University Hospital of Ioannina.
NCT03299452 ↗	Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor	Unknown status	Alphacait, LLC	Phase 2	2017-01-01	This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.
NCT03299452 ↗	Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor	Unknown status	Haining Health-Coming Biotech Co., Ltd.	Phase 2	2017-01-01	This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.

Clinical Trial Conditions for DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE

Condition Name

Condition Name for DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE
Intervention	Trials
CYSTOID MACULAR EDEMA	1
Diabetes	1
Metastatic Cancer	1
Non Small Cell Lung Cancer	1

Condition MeSH

Condition MeSH for DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE
Intervention	Trials
Neoplasm Metastasis	1
Macular Edema	1
Edema	1
Carcinoma, Non-Small-Cell Lung	1

Clinical Trial Locations for DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE

Trials by Country

Trials by Country for DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE
Location	Trials
China	1
Greece	1
United States	1

Trials by US State

Trials by US State for DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE
Location	Trials
Pennsylvania	1

Clinical Trial Progress for DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE

Clinical Trial Phase

Clinical Trial Phase for DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE
Clinical Trial Phase	Trials
Completed	3
Unknown status	1

Clinical Trial Sponsors for DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE

Sponsor Name

Sponsor Name for DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE
Sponsor	Trials
University of Ioannina	1
Alphacait, LLC	1
Haining Health-Coming Biotech Co., Ltd.	1

Sponsor Type

Sponsor Type for DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE
Sponsor	Trials
Other	5
Industry	2

DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE Market Analysis and Financial Projection

Clinical Trials, Market Analysis, and Projections for Dextrose, Magnesium Acetate, Potassium Acetate, and Sodium Chloride

Introduction

The combination of dextrose, magnesium acetate, potassium acetate, and sodium chloride is commonly used in parenteral nutrition and electrolyte replenishment solutions. These components are crucial in maintaining fluid balance, electrolyte levels, and providing necessary calories. Here, we will delve into the clinical trials, market analysis, and future projections for these solutions.

Clinical Trials and Efficacy

Overview of Clinical Trials

Clinical trials involving these components, such as the PLASMA-LYTE 56 and 5% Dextrose Injection, have been conducted to assess their safety and efficacy. For instance, a single-blind randomized controlled trial involving 104 patients undergoing deceased-donor kidney transplant under general anesthesia used a solution containing dextrose, magnesium acetate tetrahydrate, potassium acetate, and sodium chloride[1].

Safety and Efficacy

These solutions have been shown to be effective in restoring electrolyte balance and providing necessary calories. However, they come with specific precautions. For example, solutions containing magnesium should be used cautiously in patients with hypermagnesemia or severe renal impairment. Similarly, potassium-containing solutions must be administered carefully to avoid hyperkalemia, especially in patients with renal insufficiency or those treated with certain medications like ACE inhibitors[4].

Adverse Reactions

Adverse reactions reported include hypersensitivity reactions, hyperkalemia, and metabolic disturbances. It is crucial to monitor patients closely for signs of these reactions and adjust the administration rate accordingly[4].

Market Analysis

Current Market

The market for parenteral nutrition and electrolyte solutions is significant, driven by the need for effective fluid and electrolyte management in clinical settings. Companies like ICU Medical, Inc., and Baxter Healthcare Corp. are key players in this market, offering various formulations of these solutions[1].

Market Trends

There is a growing demand for customized parenteral nutrition solutions that cater to specific patient needs. This trend is driven by the increasing awareness of personalized medicine and the need to minimize complications associated with fluid and electrolyte imbalances.

Competitive Landscape

The competitive landscape is characterized by a few major players, with ongoing research and development aimed at improving the safety and efficacy of these solutions. For example, Terumo Corp. is involved in various clinical trials and has a robust pipeline of products targeting electrolyte imbalances and other conditions[3].

Market Projections

Future Demand

The demand for parenteral nutrition and electrolyte solutions is expected to grow, driven by an aging population and an increase in chronic diseases that require long-term fluid and electrolyte management.

Technological Advancements

Advancements in technology, such as the development of more stable and convenient formulations, are expected to drive market growth. For instance, the use of flexible plastic containers and vented intravenous administration sets is becoming more prevalent, enhancing patient safety and convenience[4].

Regulatory Environment

Regulatory bodies continue to play a crucial role in ensuring the safety and efficacy of these solutions. Recent updates and guidelines from regulatory agencies will influence the development and approval of new formulations, ensuring that they meet stringent safety standards[2].

Key Components and Their Roles

Dextrose

Dextrose provides a source of carbohydrates, helping to restore blood glucose levels and minimize liver glycogen depletion. It also exerts a protein-sparing action, which is beneficial in patients requiring parenteral nutrition[5].

Magnesium Acetate

Magnesium is essential for various bodily functions, including muscle and nerve function. However, its administration must be cautious in patients with hypermagnesemia or severe renal impairment[4].

Potassium Acetate

Potassium is critical for maintaining proper heart function and muscle contractions. Solutions containing potassium acetate are indicated in patients requiring parenteral administration of potassium, but they must be used with caution to avoid hyperkalemia[5].

Sodium Chloride

Sodium chloride helps maintain fluid balance and is essential for various bodily functions. However, its administration should be careful in patients with conditions that may cause sodium retention and fluid overload[4].

Clinical Indications and Usage

Parenteral Nutrition

These solutions are indicated in patients requiring parenteral administration of electrolytes and carbohydrates. They are particularly useful in surgical patients, those with severe burns, and individuals with gastrointestinal disorders that prevent oral or enteral nutrition[5].

Electrolyte Imbalance

The solutions are also used to correct electrolyte imbalances, such as hypokalemia, hypomagnesemia, and hyponatremia. The specific composition of the solution can be tailored to the patient's needs[4].

Contraindications and Precautions

Contraindications

Solutions containing potassium are contraindicated in diseases where high potassium levels may be encountered, such as hyperkalemia. Similarly, solutions with magnesium should be avoided in patients with hypermagnesemia or severe renal impairment[5].

Precautions

Administration of these solutions requires careful monitoring to avoid complications such as hyperglycemia, hyperkalemia, and fluid overload. Patients with diminished renal function, cardiac disease, or severe hepatic insufficiency require special caution[4].

Conclusion

The combination of dextrose, magnesium acetate, potassium acetate, and sodium chloride in parenteral solutions is a critical component of clinical care, particularly in managing fluid and electrolyte balance. While these solutions are effective, their administration must be carefully managed to avoid adverse reactions.

Key Takeaways

• Clinical Efficacy: These solutions are effective in restoring electrolyte balance and providing necessary calories.
• Market Trends: There is a growing demand for customized parenteral nutrition solutions.
• Regulatory Environment: Regulatory updates and guidelines play a crucial role in ensuring safety and efficacy.
• Key Components: Each component has a specific role in maintaining bodily functions.
• Clinical Indications: These solutions are indicated in parenteral nutrition and correcting electrolyte imbalances.
• Contraindications and Precautions: Careful monitoring is necessary to avoid complications.

FAQs

What are the common indications for dextrose, magnesium acetate, potassium acetate, and sodium chloride solutions?

These solutions are indicated in patients requiring parenteral administration of electrolytes and carbohydrates, particularly in surgical patients, those with severe burns, and individuals with gastrointestinal disorders.

What are the potential adverse reactions associated with these solutions?

Adverse reactions include hypersensitivity reactions, hyperkalemia, hyperglycemia, and metabolic disturbances. Careful monitoring is necessary to avoid these complications.

How should these solutions be administered?

These solutions should be administered only by intravenous infusion and as directed by the physician. The dose and rate of injection are dependent upon the age, weight, and clinical condition of the patient.

What are the contraindications for these solutions?

Solutions containing potassium are contraindicated in diseases where high potassium levels may be encountered, such as hyperkalemia. Similarly, solutions with magnesium should be avoided in patients with hypermagnesemia or severe renal impairment.

What role do regulatory bodies play in the approval of these solutions?

Regulatory bodies ensure the safety and efficacy of these solutions through stringent guidelines and approval processes, influencing the development and approval of new formulations.

Sources

1. Synapse Patsnap: Dextrose/Magnesium Acetate Tetrahydrate/Potassium Acetate/Sodium Chloride.
2. Federal Register: Potassium Chloride in Dextrose and Sodium Chloride.
3. Synapse Patsnap: Terumo Corp. - Drug pipelines, Patents, Clinical trials.
4. FDA: PLASMA-LYTE 56 and 5% Dextrose Injection.
5. Drugs.com: Potassium Chloride in Dextrose and Sodium Chloride.