CLINICAL TRIALS PROFILE FOR AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE

All Clinical Trials for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02360826 ↗	Statin Distribution	Completed	American Heart Association	Phase 1	2014-06-17	Anticipating an increased use of statins in children and adolescents, it is imperative that we understand the genetic and developmental characteristics affecting the pharmacokinetics and pharmacodynamics of statins in childhood and adolescence. Simply extrapolating pediatric dosing guidelines from adult dose-exposure-response relationships fails to recognize the potential impact of growth and development in pediatric patients, which may have important clinical implications for drug efficacy or toxicity. Current evidence indicates that genetic variation in the SLCO1B1 transporter is important for statin disposition and toxicity in adults. The ontogeny of SLCO1B1 during human growth and development has not been well characterized, and limited pediatric data indicate that the genotype-phenotype relationship in children is the opposite of that observed in adults. Therefore, investigating the relative roles of SLCO1B1 ontogeny and genetic variation in statin disposition and response is key to determining the age at which the statin dose-exposure-response relationship mimics adults, and has important implications for other medications transported by the SLCO1B1 protein. As the first step in this process, our specific aims for the current investigation are 1) to determine the effect of genetic variation of SLCO1B1 on the pharmacokinetics of pravastatin and simvastatin by comparing Cmax, AUC and elimination between children and adolescents with 2 functional SLCO1B1 alleles and those with one or more variant alleles, and 2) to determine if the magnitude of the genetic effect on pravastatin pharmacokinetics (defined as Cmax, AUC and elimination) is equivalent to the effect on simvastatin pharmacokinetics. As a secondary aim, Cmax and AUC of pravastatin and simvastatin will be compared between children and adolescents for each genotype group. These results will be utilized to determine the sample size necessary to adequately power future studies characterizing the role of ontogeny on statin disposition. The ultimate goal of this proposed investigation is to establish the role of genetic variation in key transporters on the dose-exposure relationship of two commonly used statin drugs in children. This study is the first step in a series of investigations aimed at determining the mechanisms behind variations in physiologic response, clinical efficacy and significant adverse effect risk that surround the statin drugs in children and adolescents.
NCT01690039 ↗	Influence of Polymorphisms in the ATP6V1 Gene of the V-ATPase on the Development of Incomplete Distal Renal Tubular Acidosis	Completed	University Hospital Inselspital, Berne		2012-09-01	Purpose 1. To compare the performance of the two currently employed urinary acidifications tests in stone formers, the furosemide/fludrocortisone and ammonium chloride loading test. 2. To study the impact of polymorphisms in the genes ATP6V1B1, ATP6V0A4 and SLC4A1 on urinary acidification in stone formers.
NCT01440478 ↗	The Effects of Urinary pH Changes on an Investigational Compound in Healthy Subjects	Completed	Eli Lilly and Company	Phase 1	2011-09-01	This study is designed to explore the effect of increased and decreased urinary pH on the single pharmacokinetic (PK) dose of LY2140023 and its active metabolite LY404039. All participants will receive the three treatments in a randomized order.

Clinical Trial Conditions for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE

Condition Name

Condition Name for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE
Intervention	Trials
Healthy	1
Healthy Subjects	1
Nephrolithiasis	1

Condition MeSH

Condition MeSH for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE
Intervention	Trials
Acidosis	1
Nephrolithiasis	1
Kidney Calculi	1

Clinical Trial Locations for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE

Trials by Country

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Trials by Country for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE
Location	Trials
United Kingdom	1
United States	1
Switzerland	1

Trials by US State

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Trials by US State for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE
Location	Trials
Missouri	1

Clinical Trial Progress for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE

Clinical Trial Phase

Clinical Trial Phase for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE
Clinical Trial Phase	Trials
Phase 1	2
N/A	1

Clinical Trial Status

Clinical Trial Status for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE
Clinical Trial Phase	Trials
Completed	4

Clinical Trial Sponsors for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE

Sponsor Name

Sponsor Name for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE
Sponsor	Trials
Eli Lilly and Company	1
University Hospital Inselspital, Berne	1
American Heart Association	1

Sponsor Type

Sponsor Type for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE
Sponsor	Trials
Other	4
Industry	1

Clinical Trials, Market Analysis, and Projections for Normal Saline Solutions: A Comprehensive Overview

Introduction to Normal Saline Solutions

Normal saline, often referred to as 0.9% sodium chloride solution, is a widely used intravenous fluid in clinical settings. It is isotonic, meaning it has the same concentration of solutes as human blood, making it an ideal choice for various medical applications, including hydration, electrolyte balance, and as a vehicle for administering medications.

Clinical Trials: Comparing Saline and Buffered Crystalloids

Acute Kidney Injury (AKI) Study

A significant clinical trial published in JAMA compared the effects of buffered crystalloid solutions versus saline on renal complications in ICU patients. This double-blind, cluster randomized, double-crossover trial involved 2278 patients across four ICUs in New Zealand. The results showed that the use of buffered crystalloid did not reduce the risk of AKI compared to saline. The incidence of AKI was 9.6% in the buffered crystalloid group and 9.2% in the saline group, with no significant difference in renal replacement therapy (RRT) use or in-hospital mortality[1].

Diabetic Ketoacidosis (DKA) Study

Another study, a subgroup analysis of the SALT-ED and SMART trials, compared balanced crystalloids (such as lactated Ringer’s or Plasma-Lyte) with saline in adults presenting with DKA. This study suggested that balanced crystalloid therapy may lead to faster resolution of DKA compared to saline, although it did not specifically address normal saline solutions[4].

Market Analysis for Normal Saline Solutions

Global Market

The global market for normal saline for parenteral use is projected to grow significantly. As of 2023, the market size was valued at $3.44 billion and is expected to reach $5.48 billion by 2030, with a Compound Annual Growth Rate (CAGR) of 6.9%. This growth is driven by the increasing prevalence of conditions such as dehydration, electrolyte imbalances, and sepsis, particularly in neonates and children[2].

U.S. Market

In the United States, the normal saline for parenteral use market was valued at $1.19 billion in 2022 and is projected to grow at a CAGR of 7.4% during the forecast period. The rising incidence of dehydration and hypovolemia-associated disorders, along with an increase in patient visits and admissions, are key factors driving this growth. However, the COVID-19 pandemic had a temporary negative impact on the market due to reduced surgeries and patient visits[5].

Market Drivers

Increasing Prevalence of Medical Conditions

The rising prevalence of conditions such as diarrhea, especially in children, and neonatal sepsis, contributes significantly to the demand for normal saline solutions. For instance, neonatal sepsis occurs in 1 to 8 per 1,000 live births in Victoria, Australia, and globally in around 1 to 50 per 1,000 live births annually[2].

Hospital Admissions and Surgical Procedures

The increasing number of hospital admissions and surgical procedures also boosts the demand for normal saline. Hospitals use normal saline extensively for hydration, wound dressing, sepsis treatment, and hemorrhage management, among other applications[2][5].

Production and Supply Chain

Despite occasional shortages, such as those experienced in the U.S. following Hurricane Maria, manufacturers are investing in expanding their production capacities to meet the growing demand. This investment is expected to further bolster market growth[2].

Market Challenges

Shortages and Supply Chain Disruptions

Historical shortages of saline solutions, particularly during events like Hurricane Maria, have highlighted the vulnerability of the supply chain. These disruptions can temporarily impact market growth and availability[2].

COVID-19 Pandemic Impact

The COVID-19 pandemic had a significant impact on the market, particularly in 2020, due to reduced patient visits and surgeries. However, the market has since recovered and is projected to continue growing[5].

Clinical Applications of Normal Saline

Hydration and Electrolyte Balance

Normal saline is widely used for hydration and to correct electrolyte imbalances. Its isotonic nature makes it an ideal choice for maintaining fluid balance without causing significant shifts in electrolyte concentrations[2].

Wound Dressing and Sepsis Treatment

Normal saline is also used for wound dressing and as part of the treatment protocol for sepsis. Its sterile and isotonic properties make it suitable for these applications[2].

Vehicle for Medications

Normal saline serves as a vehicle for administering various medications intravenously, making it a versatile solution in clinical settings[2].

Future Projections

Market Growth

The market for normal saline solutions is expected to continue growing, driven by increasing medical needs and the expansion of production capacities by manufacturers. The global market is projected to reach $5.48 billion by 2030, while the U.S. market is expected to grow at a CAGR of 7.4% during the forecast period[2][5].

Technological Advancements

Future advancements in manufacturing and supply chain management are likely to improve the availability and quality of normal saline solutions. This could include more efficient production methods and better logistics to mitigate shortages.

Key Takeaways

• Clinical Trials: Buffered crystalloids did not show a significant advantage over saline in reducing AKI in ICU patients, but balanced crystalloids may be superior in resolving DKA.
• Market Analysis: The global and U.S. markets for normal saline are projected to grow significantly, driven by increasing medical needs and production expansions.
• Market Drivers: Rising prevalence of medical conditions, increasing hospital admissions, and surgical procedures are key drivers.
• Challenges: Historical shortages and pandemic impacts are challenges that need to be addressed.
• Clinical Applications: Normal saline is used extensively for hydration, electrolyte balance, wound dressing, sepsis treatment, and as a vehicle for medications.

FAQs

What is the primary use of normal saline in clinical settings?

Normal saline is primarily used for hydration, correcting electrolyte imbalances, wound dressing, and as a vehicle for administering medications.

How is the global market for normal saline projected to grow?

The global market for normal saline is projected to grow from $3.44 billion in 2023 to $5.48 billion by 2030, with a CAGR of 6.9%.

What was the impact of the COVID-19 pandemic on the normal saline market?

The COVID-19 pandemic had a temporary negative impact on the market due to reduced surgeries and patient visits, but the market has since recovered.

Are there any clinical trials comparing normal saline with other fluids?

Yes, there have been trials comparing normal saline with buffered crystalloids and balanced crystalloids, particularly in the context of AKI and DKA.

What are the main drivers of the normal saline market growth?

The main drivers include the rising prevalence of medical conditions, increasing hospital admissions, and surgical procedures, as well as the expansion of production capacities by manufacturers.

Sources

1. Effect of a Buffered Crystalloid Solution vs Saline on Acute Kidney Injury in Critically Ill Adults: A Cluster Randomized Trial. JAMA, 2015.
2. Normal Saline for Parenteral Use Market Growth Report [2030]. Fortune Business Insights.
3. Clinical Trial Protocol - NOV03 (100% Perfluorohexyloctane) Sponsor: Bausch & Lomb Incorporated. ClinicalTrials.gov.
4. Clinical Effects of Balanced Crystalloids vs Saline in Adults With Diabetic Ketoacidosis: A Subgroup Analysis of 2 Randomized Clinical Trials. JAMA Network Open, 2020.
5. U.S. Normal Saline for Parenteral Use Market Growth [2030]. Fortune Business Insights.