Prevention of Metabolic Acidosis in Preterm Neonates by Replacing Sodium Chloride With Sodium Acetate in Parenteral Nutrition - A Randomized Controlled Trial. (PROTECT Trial)

The goal of this clinical trial is to learn if the addition of sodium acetate in neonatal PN works to prevent and treat metabolic acidosis and associated comorbidities in preterm neonates. It will also teach about the optimal doses of sodium acetate in PN. The main questions it aims to answer are:
Is the incidence of metabolic acidosis reduced in preterm neonates who received daily Sodium acetate in PN therapy (treatment) during the initial weeks of life compared with individuals who received sodium chloride in PN (standard)? Is the rate of neonatal comorbidities reduced in preterm neonates who received daily Sodium acetate in PN therapy (treatment) during the initial weeks of life compared with individuals who received sodium chloride in PN (standard)? What are the optimal neonatal dosing recommendations/guidelines of sodium acetate in daily PN, which are required to prevent/treat metabolic acidosis in the early life of preterm neonates? Researchers will compare Sodium acetate in PN therapy to sodium chloride in PN to see if Sodium acetate works to prevent and treat metabolic acidosis and associated comorbidities.
Included Participants:
All the neonates were admitted to the NICU of AKUH and received PN during 28 days of their lives.
Participants will receive sodium acetate or sodium chloride Written informed consent was obtained by parents/legal representatives (according to local regulations) before the initiation of PN. Gestational age < 33 weeks Included in the study before 72 hours of life

Start Date10 Jul 2024

Sponsor / Collaborator

AGA Khan University Hospital

CTR20241621 / RecruitingPhase 1/2

镓[68Ga]-NYM032注射液在健康受试者、前列腺癌患者体内的药代动力学、生物分布、辐射剂量和安全性研究

[Translation] Study on the pharmacokinetics, biodistribution, radiation dose and safety of gallium [68Ga]-NYM032 injection in healthy subjects and prostate cancer patients

Ⅰa期主要目的：评估68Ga-NYM032注射液在健康受试者体内的安全性和辐射安全性。次要目的： 1、评价不同剂量68Ga-NYM032注射液在健康受试者体内的药代动力学； 2、评价不同剂量68Ga-NYM032注射液在健康受试者体内的生物分布； 3、评价不同剂量68Ga-NYM032注射液在健康受试者体内的图像质量。 Ⅰb/Ⅱa期主要目的：评估68Ga-NYM032注射液在前列腺癌患者体内的安全性和辐射安全性。次要目的： 1、评价68Ga-NYM032注射液在前列腺癌患者体内的药代动力学； 2、评价68Ga-NYM032注射液在前列腺癌患者体内的生物分布； 3、评价68Ga-NYM032注射液在前列腺癌患者体内的图像质量； 4、评价68Ga-NYM032注射液在前列腺癌患者体内的诊断效能； 5、评价不同阅片间和同一阅片者内68Ga-NYM032注射液在前列腺癌患者体内的诊断一致性。

[Translation]

Phase Ia Main purpose: To evaluate the safety and radiation safety of 68Ga-NYM032 injection in healthy subjects. Secondary purposes: 1. To evaluate the pharmacokinetics of different doses of 68Ga-NYM032 injection in healthy subjects; 2. To evaluate the biodistribution of different doses of 68Ga-NYM032 injection in healthy subjects; 3. To evaluate the image quality of different doses of 68Ga-NYM032 injection in healthy subjects. Phase Ib/IIa Main purpose: To evaluate the safety and radiation safety of 68Ga-NYM032 injection in patients with prostate cancer. Secondary objectives: 1. Evaluate the pharmacokinetics of 68Ga-NYM032 injection in patients with prostate cancer; 2. Evaluate the biodistribution of 68Ga-NYM032 injection in patients with prostate cancer; 3. Evaluate the image quality of 68Ga-NYM032 injection in patients with prostate cancer; 4. Evaluate the diagnostic efficacy of 68Ga-NYM032 injection in patients with prostate cancer; 5. Evaluate the diagnostic consistency of 68Ga-NYM032 injection in patients with prostate cancer between different readers and within the same reader.

Start Date04 Jun 2024

Sponsor / Collaborator

Norroy Bioscience Co., LTD

NCT06354088 / RecruitingPhase 1IIT

Human Models of Selective Insulin Resistance: Alpelisib, Part I

The goal of this clinical trial is to understand how the blood sugar-lowering hormone insulin works in healthy adults versus those who are at risk for type 2 diabetes. The study will use a drug called alpelisib, which interferes with insulin's actions in the body, to answer the study's main question: does the liver continue to respond to insulin's stimulation of fat production even when it loses the ability to stop making glucose (sugar) in response to insulin. Researchers will compare the impact of single doses of both alpelisib and placebo (inert non-drug) in random order (like flipping a coin) in study participants. Participants will be asked to stay twice overnight in the hospital, take single doses of alpelisib and placebo (one or the other on each of the two hospital stays), and receive intravenous (into the vein) infusions of non-radioactive "tracer" molecules that allow researchers to measure the production of glucose (sugar) and fats by the liver. Measurements will be done both overnight, while participants are asleep and fasting (not eating or drinking other than water) and while consuming a standardized diet of nutritional beverages during the following day.
The objective is to evaluate the effect of lowering insulin levels, while maintaining constant mild hyperglycemia, on plasma glucose and lipid levels.

Start Date24 Apr 2024

Sponsor / Collaborator

Columbia University

[+1]

100 Clinical Results associated with Sodium Acetate

100 Translational Medicine associated with Sodium Acetate

100 Patents (Medical) associated with Sodium Acetate

789

Literatures (Medical) associated with Sodium Acetate

01 Feb 2025·Food Chemistry

Substitution of NaCl by organic sodium salts in cured large yellow croaker (Larimichthys crocea): Improvement of the quality and flavor characteristic

Article

Author: Yang, Chao ; Zhao, Yuying ; Deng, Shanggui ; Shuaibu, Abubakar ; Lan, Hao ; Gao, Yuanpei ; Xu, Yi

For lowering the daily intake of salt, the study evaluated the impact of various organic sodium salts (OSS), including sodium acetate (SA), sodium citrate (SC), and sodium lactate (SL), on the quality and volatile flavor profiles of large yellow croaker. The results showed that the 5 % SC and 5 % SL treatments significantly improved water holding capacity (WHC), texture, and color (p < 0.05). These groups also demonstrated compact microstructures and maintained strong sensory acceptability. However, as the curing concentration increased, protein unfolding and oxidation intensified, and the transition from bound and immobile water to free water was observed. This shift negatively affected WHC, texture, and cell structure. Additionally, gas chromatography-ion mobility spectrometry (GC-IMS) identified 27 volatile compounds, with OSS treatments notably enhancing flavor intensity. These findings offer valuable insights for developing low-sodium practices in the seafood industry.

01 Dec 2024·Cellular and Molecular Life Sciences

Gut microbiota-derived acetic acids promoted sepsis-induced acute respiratory distress syndrome by delaying neutrophil apoptosis through FABP4

Article

Author: Zhang, Xulong ; Zheng, Longcheng ; Zhang, Xiaoju ; Cao, Bin ; Wu, Xu ; Jia, Huayun ; Xuan, Weixia

In patients with sepsis, neutrophil apoptosis tends to be inversely proportional to the severity of sepsis, but its mechanism is not yet clear. This study aimed to explore the mechanism of fatty acid binding protein 4 (FABP4) regulating neutrophil apoptosis through combined analysis of gut microbiota and short-chain fatty acids (SCFAs) metabolism. First, neutrophils from bronchoalveolar lavage fluid (BALF) of patients with sepsis-induced acute respiratory distress syndrome (ARDS) were purified and isolated RNA was applied for sequencing. Then, the cecal ligation and puncture (CLP) method was applied to induce the mouse sepsis model. After intervention with differential SCFAs sodium acetate, neutrophil apoptosis and FABP4 expression were further analyzed. Then, FABP4 inhibitor BMS309403 was used to treat neutrophils. We found CLP group had increased lung injury score, lung tissue wet/dry ratio, lung vascular permeability, and inflammatory factors IL-1β, TNF-α, IL-6, IFN-γ, and CCL3 levels in both bronchoalveolar lavage fluid and lung tissue. Additionally, FABP4 was lower in neutrophils of ARDS patients and mice. Meanwhile, CLP-induced dysbiosis of gut microbiota and changes in SCFAs levels were observed. Further verification showed that acetic acids reduced neutrophil apoptosis and FABP4 expression via FFAR2. Besides, FABP4 affected neutrophil apoptosis through endoplasmic reticulum (ER) stress, and neutrophil depletion alleviated the promotion of ARDS development by BMS309403. Moreover, FABP4 in neutrophils regulated the injury of RLE-6TN through inflammatory factors. In conclusion, FABP4 affected by gut microbiota-derived SCFAs delayed neutrophil apoptosis through ER stress, leading to increased inflammatory factors mediating lung epithelial cell damage.

01 Dec 2024·Bioresource Technology

Comparative analysis of sulfur-driven autotrophic denitrification for pilot-scale application: Pollutant removal performance and metagenomic function

Article

Author: Jiang, Yu ; Du, Jing ; Cui, Peng ; Zou, Lei ; Ma, Min ; Li, Chaoyu ; Wan, Nianhong

Two parallel pilot-scale reactors were operated to investigate pollutant removal performance and metabolic pathways in elemental sulfur-driven autotrophic denitrification (SDAD) process under low temperature and after addition of external electron donors. The results showed that low temperature slightly inhibited SDAD (average total nitrogen removal of ∼4.7 mg L^-1) while supplement of sodium thiosulfate (stage 2) and sodium acetate (stage 3) enhanced denitrification and secretion of extracellular polymeric substances (EPS), leading to the average removal rate of 0.75 and 1.01 kg N m^-3 d^-1, respectively with over twice higher total EPS. Correspondingly, nitrogen and sulfur related microbial metabolisms especially nitrite reductase and nitric oxide reductase encoding were promoted by genera including Thermomonas and Thiobacillus. The variations revealed that extra sodium acetate improved denitrification and enriched more SDAD-related microorganisms compared with sodium thiosulfate, which potentially catalyzed the refinement of practical strategies for optimizing denitrification in low carbon to nitrogen ratio wastewater treatment.

News (Medical) associated with Sodium Acetate

09 Jan 2024

·www.businesswire.com

A.forall Announces Launch of a Generic Version of Sodium Acetate Injection 4 mEq/mL

MINNETONKA, Minn.--( BUSINESS WIRE )-- Milla Pharmaceuticals Inc., an A.forall company, announced that its partner, Woodward Pharma Services LLC , has just commercialized its Supplemental Abbreviated New Drug Application (sANDA) approval from the U.S. Food and Drug Administration (FDA) for a generic version of Sodium Acetate Injection 4 mEq/mL marketed by Fresenius Kabi USA LLC. Sodium Acetate Injection 4 mEq/mL is indicated as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also used as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. Milla Pharmaceuticals was previously granted a Competitive Generic Therapy (CGT) designation for its generic drug product, Sodium Acetate Injection, 2 mEq/mL, by the FDA in 2021, which has been commercialized since July 2021. The newly launched 4 mEq/mL is a more concentrated version marketed by Fresenius Kabi USA LLC. The approval of this Supplemental Abbreviated New Drug Application (sANDA), which occurred under priority review from the FDA because of its shortage status, has been consistent with A.forall’s last two FDA filings which were First Cycle Review Approvals. The Sodium Acetate Injection 4 mEq/mL has been consistently listed on the FDA Drug Shortages List for the last several years. “Our joint mission of making affordable medicines available to all is more then ever at the centre of what we do every day,” commented Filip Van de Vliet, CEO of A.forall. “With this sANDA, an alternative concentration of the Sodium Acetate Injection we launched two years ago, we again substantially increase the availability of a life-saving drug that U.S. patients would otherwise be lacking. Once again, the strength of our product development and regulatory teams has allowed us to bring a fast and high-quality solution to those in need.” About A.forall We Make Affordable Medicines Available To All: we develop value-added generic pharmaceuticals, solve product shortages and fill unmet medical needs so that patients can continue their treatment. At the same time, we are reducing costs to the healthcare system and increasing customer convenience for a more sustainable world. More info: About – A.forall About Milla Pharmaceuticals Milla Pharmaceuticals Inc., an A.forall company, is engaged in the development, licensing, acquisition, and commercialization of generic prescription drugs for the U.S. market focused on niche injectable and solution products for hospitals and clinics. More info: About - Milla Pharmaceuticals About Woodward Pharma Services LLC Woodward Pharma Services LLC is a specialty pharmaceutical company focused on acquiring, licensing, and commercializing branded and generic prescription drugs for the U.S. Market. Woodward has a diverse portfolio of products distributed across multiple channels. More info: Who We Are — Woodward Pharma Services LLC

Priority ReviewDrug ApprovalBreakthrough Therapy

12 Jun 2023

·www.pharmaceutical-technology.com

FDA approves Milla Pharmaceuticals’ generic version of Precedex

The drug is given by continuous infusion not exceeding 24 hours’ duration. Credit: Jochen Pippir from Pixabay. The US Food and Drug Administration (FDA) has granted approval for Milla Pharmaceuticals’ generic version of Precedex, dexmedetomidine hydrochloride injection 4mcg/ml in 50mL and 100mL. The injection is indicated for the sedation of initially intubated and mechanically ventilated patients receiving treatment in an intensive care setting. Recommended Reports Reports LOA and PTSR Model - (aspartame + cannabidiol) GlobalData Reports LOA and PTSR Model - Ropidoxuridine in Sarcomas GlobalData View all It is given by continuous infusion not exceeding 24 hours’ duration. Milla Pharmaceuticals stated that Precedex is now on the US FDA’s drug shortages list. It noted that the injection’s latest approval will help reduce the recent supply issues for the product in the country. This latest move marks Milla Pharmaceuticals’ second ‘first cycle’ FDA approval for an abbreviated new drug application (ANDA) and second paragraph IV filing. The first approval is for sodium acetate injection 2MEQ/mL, granted in 2021. The sodium acetate injection 2MEQ/mL was also an FDA drug shortage listed product. Milla Pharmaceuticals’ parent company Alter Pharma Group CEO Filip Van de Vliet stated: “This new Alter Pharma ANDA approval, which is the fifth already over a period of under three years, out of which two were after a first cycle review, makes us extremely proud. “In fact, on average only between 12% and 15% of all ANDAs filed get a first cycle approval, meaning the FDA did not identify any shortfalls or deficiencies during the first cycle review hence no additional requests are being asked.”

Drug Approval

09 Jun 2023

·www.biospace.com

Milla Pharmaceuticals Inc. and the Alter Pharma Group Announce Yet Another “First Cycle” FDA Approval for an Abbreviated New Drug Application (ANDA), Dexmedetomidine Hydrochloride Injection

MINNETONKA, Minn.--(BUSINESS WIRE)-- Milla Pharmaceuticals Inc., a subsidiary of the Alter Pharma Group, announced that it has received FDA approval for its generic version of Precedex®, Dexmedetomidine Hydrochloride Injection 4mcg/ml in 50mL and 100mL, and plans to launch in the very near future. This press release features multimedia. View the full release here: Dexmedetomidine Hydrochloride Injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. It should be administered by continuous infusion not to exceed 24 hours. Dexmedetomidine Hydrochloride Injection 4mcg/ml in 50mL and 100mL is currently on FDA’s Drug Shortages list. This latest approval of Dexmedetomidine Hydrochloride Injection will help reduce the recent supply issues for the product experienced in the U.S. This achievement marks the second “First Cycle” Approval ANDA for Milla Pharmaceuticals Inc. and the Alter Pharma Group for the U.S. market, after their first “First Cycle” Approval ANDA for Sodium Acetate Injection 2MEQ/mL in the Summer of 2021, which was also an FDA Drug Shortage listed product. This new milestone also marks the approval of our second Paragraph IV Filing and the 5th ANDA approval for the Alter Pharma Group. “This new Alter Pharma ANDA approval, which is the 5th already over a period of less than three years, out of which 2 after a first cycle review, makes us extremely proud,” commented Filip Van de Vliet, CEO of the Alter Pharma Group. “In fact, on average only between 12% and 15% of all ANDAs filed get a First Cycle Approval, meaning the FDA did not identify any shortfalls or deficiencies during the first cycle review hence no additional requests are being asked. The fact that our two most recent filings both got a First Cycle Approval can only be explained by the extremely high expertise of our scientific and regulatory teams.” About Milla Pharmaceuticals Inc. Milla Pharmaceuticals Inc., a wholly-owned subsidiary of the Alter Pharma Group, is engaged in the development, licensing, acquisition, and commercialization of generic prescription drugs for the U.S. market focused on niche injectable and solution products for hospitals and clinics. More info: About - Milla Pharmaceuticals Inc.

Drug Approval

100 Deals associated with Sodium Acetate

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Indication	Country/Location	Organization	Date
Hyponatremia	US	Hospira, Inc.	04 May 1983

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Indication	Highest Phase	Country/Location	Organization	Date
Ischemia	Preclinical	-	-	01 Apr 2023

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