Ongoing Clinical Trials for Hypotension
There are currently 4 clinical trials investigating new approaches to managing low blood pressure (hypotension) in various medical settings. These studies are exploring different medications and treatment strategies to help stabilize blood pressure in patients experiencing hypotension during serious infections, emergency situations, and surgical procedures. The trials are being conducted across several European countries including Belgium, Denmark, France, and Sweden.
Clinical trial locations
- Belgium
- Denmark
- France
- Sweden
Study of REGN7544 for Treating Adults with Low Blood Pressure Caused by Sepsis
This trial is investigating a new medication called REGN7544 for patients experiencing dangerously low blood pressure caused by severe infections, a condition known as sepsis-induced hypotension. The study is being conducted in France and is expected to conclude in April 2026.
Who can participate: Adults with a proven or suspected infection who are receiving antibiotics can join this study. Participants must have low blood pressure that has not improved with intravenous fluids and should be receiving 1 or 2 vasopressor medications while maintaining a mean arterial pressure of at least 65 mm Hg for at least 2 consecutive hours before enrollment. Both men and women can participate.
Who cannot participate: People who do not have sepsis-induced hypotension, those outside the specified age range, and individuals belonging to vulnerable populations are excluded from this study.
What the study involves: The trial is testing whether REGN7544, a monoclonal antibody that blocks a specific protein called NPR1, can reduce the need for vasopressor medications. Participants will receive either REGN7544 or a placebo through an intravenous infusion. The study will monitor blood pressure levels, the amount of vasopressors needed, and overall health outcomes. Researchers will also check for side effects and measure drug levels in the blood throughout the treatment period.
Study medication: REGN7544 is a specially designed antibody that works by blocking the NPR1 receptor, which plays a role in blood pressure regulation. The goal is to help stabilize blood pressure and reduce dependency on other blood pressure-raising medications.
Study on Early Use of Norepinephrine vs. Standard Fluid Therapy in Emergency Department Patients with Hypotension or Shock
This international trial, taking place in Denmark and Sweden, is comparing two different approaches to treating patients who arrive at the emergency department with shock or low blood pressure. The study examines whether starting treatment with norepinephrine early is more effective than using standard fluid therapy alone.
Who can participate: Adults aged 18 and older showing signs of low blood pressure or shock can join this study. Participants must have either a systolic blood pressure less than 100 mmHg or mean arterial pressure less than 65 mmHg, combined with elevated lactate levels (greater than 2.0 mmol/L) or clear signs of shock as assessed by medical professionals. Before joining, patients must have received at least 500 ml of intravenous fluid within the first 4 hours of emergency department arrival. Participants must also have a Clinical Frailty Score of 4 or less, though those with higher scores may be included if deemed suitable for intensive care.
Who cannot participate: The exclusion criteria are not fully detailed in the available information, but the study focuses specifically on patients with hypotension or shock in emergency settings.
What the study involves: Participants are randomly assigned to receive either early norepinephrine treatment or standard fluid therapy. The primary goal is to see if starting norepinephrine earlier can help stabilize blood pressure within 90 minutes and reduce the need for intensive care unit admission. The study tracks how quickly patients achieve stable blood pressure, the number of days they remain alive without needing ICU care within 30 days, and mortality rates both in the hospital and within 30 days.
Study medication: Norepinephrine (also called noradrenaline) is a vasopressor medication that works by narrowing blood vessels, which helps increase blood pressure and improve blood flow to vital organs. It is given through an intravenous infusion, with dosage adjusted based on individual patient needs.
Study on Fluid Therapy and Noradrenaline for Low Blood Pressure in Breast Reconstruction Surgery Patients
This Belgian trial is studying how to best manage blood pressure during a specific type of breast reconstruction surgery called deep inferior epigastric perforator (DIEP) free flap surgery. The study examines a careful approach to managing fluids and blood pressure during the operation.
Who can participate: Female adults between 18 and 70 years of age who are scheduled for DIEP free flap breast reconstruction can participate. Participants must sign a written informed consent form before joining the study.
Who cannot participate: Men are excluded from this study, as it specifically focuses on breast reconstruction surgery. Patients outside the specified age range and those not experiencing low blood pressure during this specific type of surgery are also excluded. Individuals from vulnerable populations cannot participate.
What the study involves: During surgery, participants receive a balanced solution called Plasma-Lyte 148, which contains important salts and minerals like magnesium, potassium, and sodium, to maintain the body’s fluid balance. If needed, norepinephrine is given to help manage blood pressure. The study uses a method called goal-directed fluid therapy, which involves carefully monitoring and adjusting the amount of fluids given during surgery. After the operation, patients are monitored in the intensive care unit or post-anesthesia care unit, where blood lactate levels are checked regularly and blood pressure is tracked. The study also monitors blood flow to the reconstructed tissue using near-infrared spectroscopy.
Study approach: Goal-directed fluid therapy is a careful method of managing fluids during surgery to ensure patients receive the optimal amount. This approach aims to maintain stable blood pressure and improve recovery by preventing both too little and too much fluid administration.
Study on the Effects of Phenylephrine and Noradrenaline on Blood Pressure and Brain Circulation in Patients with Low Blood Pressure During Brain Tumor Surgery
This Danish trial is investigating how two different medications affect blood pressure and blood flow to the brain in patients undergoing surgery to remove brain tumors. The study aims to understand which medication might be more beneficial for maintaining adequate blood flow to the brain during surgery.
Who can participate: Adults between 18 and 75 years of age who are scheduled for planned brain surgery (craniotomy) to remove a tumor can participate. The tumor must be located in the upper part of the brain (supratentorial region) and must be at least 3 centimeters in size. Both men and women can join the study. Participants must be able to provide informed consent and understand the study.
Who cannot participate: Patients who have experienced low blood pressure during anesthesia in the past are excluded from this trial. Individuals from vulnerable populations who may not be able to give proper informed consent are also excluded.
What the study involves: During brain tumor surgery, if low blood pressure occurs, patients receive either phenylephrine or noradrenaline tartrate through an intravenous infusion. Throughout the surgery, doctors closely monitor blood flow and circulation in the body, with particular focus on how the medication affects blood flow to the brain and oxygen levels. The study measures the difference in cerebral blood flow before and after treatment to evaluate which medication is more effective at maintaining proper brain circulation.
Study medications: Phenylephrine works by narrowing blood vessels to increase blood pressure, helping ensure adequate blood flow to the brain during surgery. Noradrenaline (norepinephrine) also increases blood pressure by tightening blood vessels and has additional effects on the heart. Both medications are being compared to determine which provides better outcomes for brain circulation and oxygenation during tumor removal surgery.
Summary
These four clinical trials represent diverse approaches to managing low blood pressure in different medical settings. A notable concentration of trials is occurring in Denmark, which is involved in two of the four studies. The trials span various clinical scenarios, from emergency departments to operating rooms, reflecting the broad impact of hypotension across medical care.
Interestingly, most of the trials focus on established medications like norepinephrine (noradrenaline) and phenylephrine, comparing their effectiveness in different situations or against standard care approaches. Only one trial is testing a completely new medication—REGN7544—which represents a novel approach using monoclonal antibody technology to manage sepsis-induced hypotension.
The studies also highlight different patient populations affected by low blood pressure, from critically ill patients with severe infections to those undergoing planned surgeries. This variety demonstrates the importance of understanding how to best manage blood pressure in each specific medical context to improve patient outcomes and reduce complications.
