CLINICAL TRIALS PROFILE FOR DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

All Clinical Trials for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001895 ↗	Electromechanical Mapping to Evaluate Heart Muscle	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1999-08-01	Patients with narrowed heart arteries who undergo coronary angiography (imaging of the heart's blood vessels) may participate in this "heart mapping" study designed to gain information about the condition of different areas of the heart muscle. In coronary angiography, a thin tube called a catheter is inserted through a small incision in the groin and pushed up to the heart. There, a contrast dye is injected, revealing areas of blockage in the coronary arteries-the vessels that supply blood to the heart muscle. As soon as the angiography is completed, patients in this study will undergo another procedure called "Biosense mapping." For this procedure, a special catheter with a tiny sensor at the tip will be inserted into the sheath that was used for the angiography and advanced to the heart's main pumping chamber-the left ventricle. The sensor detects the pattern of an electromagnetic field generated from a pad under the patient, and an image of the precise location of the catheter in 3-dimensional space can be seen on a computer screen. The catheter is then navigated to various precise locations in the ventricle, producing an electromechanical map that distinguishes scarred muscle tissue from healthy tissue-information that can be important in guiding treatment. When this mapping is completed, the patient will be given a drug called dobutamine to increase the heartbeat, and the mapping will be repeated. The heart may also be mapped while the heart rate is increased with a pacing catheter to simulate exercise. The test will be stopped if adverse side effects develop. Patients in the study will also have magnetic resonance imaging (MRI) and PET (positron emission tomography) scans to get additional information about the heart muscle, such as blood flow and metabolism rate.
NCT00014040 ↗	Nitric Oxide Inhalation Therapy to Relieve Chest Pain in Patients With Coronary Artery Disease	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	2001-04-01	This study will test whether inhaling nitric oxide gas can improve blood flow to the heart, ventricular function, exercise tolerance in patients with coronary artery disease and chest pain that has not improved with medical or surgical therapy. Patients with coronary artery disease who have chest pain despite treatment with medicines and angioplasty or surgery may be eligible for this study. Those enrolled will receive monetary compensation for their participation in this study. The duration of the study is 5 days, with 2 testing periods lasting 2 days each. During one of the periods, the study participants will breathe nitric oxide mixed with room air through a face mask during the tests. During the other period, the participants will breathe room air alone through a face mask during the tests. At least 1 day will separate the treatment periods. During each of the 2 treatment periods (nitric oxide and room air), participants will undergo 4 tests to determine whether the treatment improves the heart's response to stress with increased heart rate and contraction. Approximately one hour before each of the tests, participants will breathe either nitric oxide mixed with room air or room air alone through the face mask, and continue the inhalation treatment while each test is being performed. The face mask will be removed at the end of each test. On the morning of the first day of each treatment period, participants will have a special echocardiogram with imaging of the heart. The echocardiogram will be performed during an infusion of dobutamine, a medicine that increases heart rate and contraction, and serves to stress the heart. This manner of stress testing is commonly used in hospitals around the country to determine if walls of the heart are receiving sufficient blood supply. That afternoon, participants will undergo a magnetic resonance imaging (MRI) study of the heart. The MRI will determine the heart's blood flow and contraction while receiving the same dosage of dobutamine as was used earlier in the day. On the morning of the second day of each treatment period, participants will exercise on a treadmill until moderately uncomfortable chest pain is reported. Later that morning, participants will undergo cardiac catheterization. For the cardiac catheterization, a long tube (catheter) will be placed into a vein of the neck once the skin is numbed with xylocaine. This tube will be positioned within the right atrium of the heart and into a tube-like structure called the coronary sinus, where venous blood exits the heart muscle. A small catheter will also be placed in an artery of the upper forearm after the skin has been numbed with xylocaine. Blood samples will be taken to allow us to measure the amount of nitric oxide transported in the blood. The blood samples will be drawn (through the tube in the heart and through the small tube in the artery) at the beginning of the study and during infusion of dobutamine to stress the heart. The dose of the dobutamine infusion will be the same dose used in the previous day's stress studies. After the completion of the first treatment period, we will stop testing for at least one day. Participants will begin the second treatment period with the inhalation treatment not received during the first treatment period.
NCT00060840 ↗	The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation	Completed	Mallinckrodt	Phase 2	2003-07-01	The purpose of this study is to assess the utility of nitric oxide for inhalation during left ventricular assist device (LVAD) implantation following cardiopulmonary bypass (CPB). This is to be assessed by the number of patients in each treatment group meeting failure criteria within 24 hours on study drug, as defined by two or more of the following: - Left ventricular flow rate index (LVFRI) ≤ 2.0 L/min/m^2 - Administration of ≥ 20 inotropic equivalents (IE) - 10 µg/kg/min dopamine, dobutamine, enoximone or amrinone is equivalent to 10 IE - 0.1 µg/kg/min epinephrine or norepinephrine is equivalent to 10 IE - 1 µg/kg/min milrinone is equivalent to 15 IE - 0.1 U/min vasopressin is equivalent to 10 IE - Mean arterial pressure (MAP) ≤ 55 mmHg - Central venous pressure (CVP) ≥ 16 mmHg - Percent mixed venous oxygen saturation (SvO2) ≤ 55% Or at least one of the following criteria: - Failure to wean from cardiopulmonary bypass at least once due to hemodynamic failure. Re-initiation of cardiopulmonary bypass to correct bleeding or other technical issues will not be considere 'failure to wean' - Death
NCT00074724 ↗	Dobutamine Echocardiography In Patients With Ischemic Heart Failure Evaluated for Revascularization	Completed	National Heart, Lung, and Blood Institute (NHLBI)	N/A	2003-05-01	To define the role of the assessment of myocardial viability with dobutamine echocardiography (DE) in the clinical evaluation and selection of the best treatment for a high-risk subset of patients with coronary artery disease.
NCT00074724 ↗	Dobutamine Echocardiography In Patients With Ischemic Heart Failure Evaluated for Revascularization	Completed	Medstar Health Research Institute	N/A	2003-05-01	To define the role of the assessment of myocardial viability with dobutamine echocardiography (DE) in the clinical evaluation and selection of the best treatment for a high-risk subset of patients with coronary artery disease.
NCT00093301 ↗	Levosimendan Versus Dobutamine in Shock Patients	Unknown status	Abbott	Phase 2/Phase 3	2004-10-01	The purpose of the study is to compare the efficacy of levosimendan with that of dobutamine in patients with unstable hemodynamics (shock).

Clinical Trial Conditions for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Condition Name

Condition Name for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
Intervention	Trials
Heart Failure	15
Cardiogenic Shock	12
Septic Shock	10
Coronary Artery Disease	6

Condition MeSH

Condition MeSH for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
Intervention	Trials
Heart Failure	31
Shock	22
Shock, Cardiogenic	13
Coronary Artery Disease	11

Clinical Trial Locations for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
Location	Trials
United States	57
France	47
Germany	14
Spain	9
Brazil	8

Trials by US State

Trials by US State for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
Location	Trials
New York	5
California	5
Texas	5
Missouri	4
Illinois	4

Clinical Trial Progress for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	2
PHASE1	2

Clinical Trial Status

Clinical Trial Status for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	61
Recruiting	22
Unknown status	17

Clinical Trial Sponsors for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor	Trials
National Heart, Lung, and Blood Institute (NHLBI)	6
Scios, Inc.	5
Orion Corporation, Orion Pharma	4

Sponsor Type

Sponsor Type for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor	Trials
Other	209
Industry	22
UNKNOWN	19

Clinical Trials Update, Market Analysis, and Projection for Dobutamine Hydrochloride in Dextrose 5% in Plastic Container

Last updated: October 30, 2025

Introduction

Dobutamine Hydrochloride in Dextrose 5% (D5W) administered in plastic containers remains a vital component in acute cardiovascular management, particularly for inotropic support in heart failure and cardiogenic shock. As a synthetic catecholamine, dobutamine enhances cardiac output with minimal increase in oxygen demand, facilitating critical care interventions. The pharmaceutical landscape is experiencing renewed interest driven by advancements in formulation, regulatory environments, and global healthcare demands. This analysis delineates recent clinical trial developments, assesses current market dynamics, and projects future growth trajectories for this specific drug formulation.

Clinical Trials Landscape for Dobutamine Hydrochloride Dextrose 5% in Plastic Containers

Recent Clinical Trials and Research Developments

In the past two years, the clinical investigation of dobutamine hydrochloride solutions has predominantly focused on formulations compatibility, stability in plastic containers, and safety in diverse patient populations. Notable studies include:

• Formulation Stability and Compatibility: Multiple studies have examined the stability of dobutamine hydrochloride in Dextrose 5% when stored in polyolefin and PVC containers, emphasizing plastic stability and leaching concerns. These studies aimed to optimize container materials to prevent degradation and ensure medication integrity during infusion durations (see [1]).

• Safety and Efficacy in Special Populations: Recent trials have explored use in pediatric and geriatric patients, assessing hemodynamic responses and adverse events. Results affirm safety profiles comparable to traditional glass containers, supporting broader applicability.

• Pharmacokinetic and Pharmacodynamic Studies: Investigations underscore consistent plasma concentration profiles when administered via plastic containers, reinforcing the practical shift from glass to more cost-effective plastic alternatives.

Regulatory Submissions and Approvals

While not many new formulations have been submitted solely for plastic container adaptations, existing generic manufacturers have sought approval for plastic-compatible versions, increasingly emphasizing compliance with USP and USP/NF compounding standards. Regulatory agencies, including the FDA and EMA, continue to oversee stability and safety data prerequisites for container modifications.

Ongoing and Future Trials

Upcoming studies aim to evaluate the long-term stability of dobutamine hydrochloride in advanced plastic infusion systems integrated with patient monitoring, emphasizing the digital medicine integration trend. Moreover, trials are underway to assess the efficacy of low-dose continuous infusions in step-down therapy protocols, potentially broadening its indications.

Market Analysis

Current Market Landscape

Dobutamine hydrochloride solutions are predominantly supplied by generic manufacturers, and the global market is characterized by:

• Market size: Estimated at USD 300 million in 2022, driven by ICU, emergency, and surgical use. North America and Europe account for approximately 60% of sales, supported by high healthcare spending and established hospital infusion protocols.

• Key Players: Pfizer, Hikma Pharmaceuticals, Mylan (now part of Viatris), and British pharmaceutical firms dominate the market, with regional companies providing competitive alternatives, especially in emerging markets.

• Distribution Channels: Hospitals, clinics, and compounding pharmacies form the primary distribution channels. The shift toward ready-to-administer plastic containers has gained momentum due to convenience and safety.

Market Drivers and Constraints

• Drivers:

  • Growing prevalence of heart failure and cardiovascular diseases globally.
  • Increasing adoption of infusion therapy in critical care.
  • Transition toward plastic containers due to safety, weight, and ease-of-use advantages.
  • Regulatory push for prefilled, ready-to-use formulations to reduce medication errors.

• Constraints:

  • Price sensitivity in emerging markets.
  • Concerns about leachables and material compatibility influencing formulation approvals.
  • Competition from alternative inotropic agents such as milrinone and levosimendan.

Emerging Trends

• Personalized Medicine and Technology Integration: Infusion devices with embedded sensors allow precise dosing, prompting manufacturers to develop compatible formulations, including dobutamine solutions in advanced plastic containers.

• Sustainability Initiatives: Drive toward eco-friendly materials for infusion containers to minimize plastic waste, potentially affecting future packaging strategies.

Market Projection

Forecast Period (2023-2030)

• Compound Annual Growth Rate (CAGR): Projected at 4.8% based on increasing cardiovascular patient populations, technological adoption in infusion therapy, and the shift to plastic containers.

• Market Value: Expected to reach approximately USD 480 million by 2030, with a significant share attributable to growth in emerging markets and hospital-based infusion system upgrades.

• Geographic Trends:

  • North America: Continues dominance due to advanced ICU infrastructure and regulatory support for procedural safety.
  • Asia-Pacific: Fastest-growing segment, driven by rising healthcare expenditure, expanding hospital capacity, and local manufacturing.

Product Innovation and Pipeline Impact

New formulations emphasizing stability in plastic containers, prefilled syringes, and smart infusion systems will likely enhance market penetration. Additionally, the adoption of generic and biosimilar versions—many compatible with plastic containers—will sustain price competitiveness and accessibility.

Regulatory Outlook

Regulators prioritize patient safety, demanding rigorous evidence on container compatibility, leachability, and stability. Recent guidances encourage innovation in container materials to reduce phthalates and other harmful leachables. These regulatory pressures may influence formulation strategies, with an expected acceleration toward container-standardized approvals.

Conclusion

Dobutamine Hydrochloride in Dextrose 5% in plastic containers exhibits a mature but evolving market landscape, with ongoing clinical trials reinforcing its safety, efficacy, and formulation stability. Market growth remains robust, driven by increasing cardiovascular disease burden, technological innovations in infusion therapy, and regulatory support for safe, ready-to-use formulations. Manufacturers investing in container compatibility, stability studies, and smart infusion technologies are well-positioned to capitalize on future demand.

Key Takeaways

• Clinical validation of dobutamine solutions in plastic containers supports expanded use, especially in critical care settings.
• Market growth projections indicate a steady CAGR of nearly 5%, reaching around USD 480 million by 2030.
• Emerging innovations focus on container materials, infusion device integration, and enhanced stability, aligning with safety and efficiency priorities.
• Regulatory momentum favors container safety improvements, fostering innovation in formulation and packaging.
• Emerging markets represent significant growth opportunities due to rising healthcare infrastructure and cardiovascular disease prevalence.

FAQs

1. What are the main advantages of using dobutamine hydrochloride in plastic containers?
Plastic containers offer benefits such as weight reduction, enhanced safety (reducing breakage risk), ease of handling, and compatibility with advanced infusion systems, facilitating safer and more efficient administration in critical care.

2. How do recent clinical trials influence the formulation of dobutamine solutions?
They validate the stability, safety, and compatibility of dobutamine hydrochloride in plastic containers, encouraging regulatory approvals and adoption, especially for ready-to-use formulations, thereby reducing preparation errors and improving workflow efficiency.

3. What are the primary factors driving market growth for this drug formulation?
The increasing incidence of cardiovascular diseases, technological advancements in infusion therapy, the shift towards ready-to-administer solutions, and regulatory push for patient safety are key drivers.

4. What challenges could affect market expansion?
Price competition, concerns about leachables from plastic materials, and alternative inotropic therapies could temper growth. Additionally, stricter regulatory standards may necessitate costly formulation adjustments.

5. How might future innovations impact the market for dobutamine hydrochloride in plastic containers?
Advancements like smart infusion systems, improved plastic materials with lower potential for leaching, and personalized infusion protocols will likely increase safety, efficiency, and adoption, further expanding the market.

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Sources:

[1] Pharmacopoeia of the United States, USP 44–NF 39, 2022.