Ongoing Clinical Trials for Septic Shock
Septic shock is a life-threatening condition where infection leads to dangerously low blood pressure and organ failure. Currently, 16 clinical trials are investigating new treatments to improve survival and organ function in patients experiencing this critical condition. These studies are testing various medications including antibiotics, blood pressure support drugs, immune therapies, and metabolic treatments across multiple countries in Europe.
Clinical trial locations
- Austria
- Czechia
- Denmark
-
France
- A Study of Levetiracetam for Prevention and Treatment of Delirium in Adult ICU Patients with Septic Shock
- Study on Ivabradine for Heart Rate Control and Survival in Adults with Septic Shock
- Study on Adding Vasopressin to Treat Patients with Septic Shock
- Study on Landiolol Hydrochloride and Sodium Chloride for Reducing Mortality in Patients with Septic Shock and High Heart Rate
- Study on L-Carnitine and Cobamamide for Patients with Septic Shock and Acute Kidney Injury
- Study on Nicotinamide for Preventing Kidney Problems in Septic Shock Patients
- Study on the Effects of Landiolol Hydrochloride for Patients with Microcirculatory Issues During Septic Shock
- Study on the Effects of Mesenchymal Stem Cells and Human Albumin Solution on Organ Failure in Patients with Severe Septic Shock
- Germany
- Italy
-
Spain
- Study on the Effect of Human Serum Albumin in Critically Ill Patients with Septic Shock at High Risk of Acute Kidney Injury
- Study on Noradrenaline and Terlipressin for Treating Septic Shock in Patients
- Study on Resuscitation in Early Septic Shock Using Sodium Chloride and a Drug Combination for Patients with Septic Shock
A Study of Levetiracetam for Prevention and Treatment of Delirium in Adult ICU Patients with Septic Shock
This French study examines whether levetiracetam, a medication typically used to prevent seizures, can help prevent and treat delirium in patients with septic shock who are in intensive care. Delirium is a state of confusion and altered mental function that commonly affects critically ill patients.
Who can participate: Adults aged 18 or older who are in intensive care with septic shock that has been present for less than 24 hours. Participants must have been in the ICU for less than 96 hours and have confirmed infection with organ dysfunction measured by a SOFA score of 2 or higher. They must also require medications to maintain blood pressure and have elevated lactate levels in the blood.
Who cannot participate: People under 18 years old, those with known epilepsy or a history of seizures, anyone currently taking anti-epileptic medications, those with severe kidney failure requiring dialysis, pregnant or breastfeeding women, and patients with pre-existing brain injuries or psychiatric conditions requiring medication.
What the study involves: Participants will receive either levetiracetam or a placebo through intravenous infusion for seven days. The main goal is to determine if levetiracetam can increase the number of days patients remain alert and free from delirium during their first two weeks of treatment. Researchers will monitor mental state, need for breathing support, and overall recovery. A follow-up assessment will occur three months after the study begins to evaluate thinking abilities, emotional well-being, and ability to perform daily activities.
Treatment being tested: Levetiracetam is an anti-seizure medication that works by decreasing abnormal brain activity. In this trial, it is being studied for its potential to prevent confusion and altered mental states in patients with septic shock.
Study Comparing Meropenem and Piperacillin/Tazobactam for Adults with Sepsis
This Danish trial compares two different antibiotic treatments for critically ill adults with sepsis. The study aims to determine which medication is more effective in treating severe infections and improving survival outcomes.
Who can participate: Adults aged 18 or older who are critically ill with sepsis or septic shock according to the Sepsis-3 criteria. This includes having a suspected or confirmed infection with an acute increase of 2 or more points in the SOFA score. Participants must need at least one form of intensive support, such as mechanical ventilation, non-invasive breathing assistance, continuous oxygen therapy, or medications to support blood pressure or heart function.
Who cannot participate: The study excludes patients who are not critically ill, do not have sepsis or septic shock, are outside the specified age range, or do not meet the specific medical criteria for the trial.
What the study involves: Participants will be randomly assigned to receive either meropenem or piperacillin/tazobactam, both given through intravenous infusion. Researchers will monitor survival rates, days alive without needing life support, days spent out of the hospital, and overall quality of life. The study will also track serious side effects and the presence of resistant bacteria.
Treatments being tested: Meropenem and piperacillin/tazobactam are both broad-spectrum antibiotics used to treat severe bacterial infections. Meropenem works by preventing bacteria from building cell walls, leading to bacterial death. Piperacillin/tazobactam combines a penicillin antibiotic with a substance that prevents bacteria from breaking down the antibiotic, making it more effective.
Study on Early Use of Vasopressin and Norepinephrine for Patients with Septic Shock
This Italian study investigates whether starting vasopressin earlier, alongside norepinephrine, can improve kidney function in patients with septic shock during their first week in intensive care.
Who can participate: Adults between 18 and 80 years old who have been diagnosed with septic shock and are in intensive care within 24 hours of diagnosis. Participants must be able to provide informed consent and require norepinephrine at a dosage of at least 0.25 micrograms per kilogram per minute based on ideal body weight.
Who cannot participate: Patients outside the age range of 18 to 80 years, those not experiencing septic shock, patients who cannot provide informed consent, and those who do not meet the specific medical requirements of the study.
What the study involves: Participants will receive vasopressin and norepinephrine intravenously. The study will monitor whether early use of vasopressin affects the need for kidney support treatments during the first week in intensive care. Researchers will assess kidney perfusion using specialized ultrasound techniques, measure fluid balance, and monitor for complications such as heart rhythm problems. The study will also track ICU length of stay and mortality rates at 28 and 90 days.
Treatments being tested: Vasopressin and norepinephrine are both vasopressor medications used to increase blood pressure in patients with septic shock. Vasopressin works by binding to receptors on blood vessels, causing them to constrict and thereby raising blood pressure. Norepinephrine stimulates alpha-adrenergic receptors, also leading to blood vessel constriction and increased blood pressure.
Study on Ivabradine for Heart Rate Control and Survival in Adults with Septic Shock
This French trial examines whether ivabradine can help control heart rate and improve survival over 28 days in patients experiencing septic shock with rapid heartbeat.
Who can participate: Adults aged 18 or older with proven or suspected infection and septic shock lasting at least 2 hours but less than 24 hours. Participants must have a heart rate of 95 beats per minute or higher and require medications to maintain blood pressure at or above 65 mmHg despite fluid treatment. They must also be affiliated with a social security system and provide informed consent.
Who cannot participate: Patients not experiencing septic shock, those outside the specified age range, individuals not part of the designated clinical trial groups, and those not affiliated with a social security system.
What the study involves: Participants will receive either ivabradine tablets or a placebo through an enteral feeding tube. The study is conducted in two stages: the first focuses on how well ivabradine controls heart rate, and the second assesses its impact on survival rates. Researchers will closely monitor heart rate to ensure it falls within 80-94 beats per minute by hour 48. The trial will continue for 28 days, during which health and response to treatment will be regularly evaluated.
Treatment being tested: Ivabradine is a heart rate-reducing medication that works by selectively blocking specific channels in the heart’s pacemaker cells, which slows down heart rate without affecting blood pressure. It is being studied to determine if controlling heart rate can improve survival in patients with septic shock.
Study on the Effect of Human Serum Albumin in Critically Ill Patients with Septic Shock at High Risk of Acute Kidney Injury
This Spanish study evaluates whether infusion of human serum albumin can help prevent severe acute kidney injury in critically ill patients with septic shock during the first week after the onset of their condition.
Who can participate: Adults between 18 and 84 years old who have been diagnosed with septic shock within the last 24 hours according to the Sepsis-3 definition. Participants must be at high risk of acute kidney injury as determined by specific urinary biomarker tests, show fluid responsiveness, have started antibiotic treatment within the first 3 hours of suspected infection, and have a SOFA score of 4 or higher. Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control.
Who cannot participate: Patients not critically ill with septic shock, those without high risk of acute kidney injury, individuals outside the specified age range, and patients not meeting specific health criteria set by the study.
What the study involves: Participants will receive either human albumin solution or a placebo through intravenous infusion. The study will monitor kidney function and overall health for several weeks. The primary focus is on the incidence of acute kidney injury during the first 7 days according to KDIGO guidelines. Secondary outcomes include 28-day mortality rates, need for organ support, length of mechanical ventilation, and levels of specific biomarkers.
Treatment being tested: Human serum albumin is a protein solution that works by expanding blood volume and improving circulation, which may help stabilize blood pressure and support kidney function in patients with septic shock.
Study on the Effects of Immunoglobulin A, G, and M in Patients with Peritonitis and Sepsis After Infection Control
This German and Austrian study investigates whether Pentaglobin, a solution containing immunoglobulins, can help improve organ function in patients with peritonitis and sepsis who have undergone procedures to control the source of infection.
Who can participate: Adults with secondary or quaternary peritonitis who have undergone source control procedures within 6 hours of indication, have sepsis or septic shock, a SOFA score of 8 or higher, blood IL-6 concentration of 1000 pg/ml or more, and have started antibiotic treatment within 12 hours of ICU admission. Informed consent must be signed by the patient or legal representative.
Who cannot participate: Patients without secondary or quaternary peritonitis or those without sepsis are excluded from the study.
What the study involves: Participants will receive Pentaglobin through intravenous infusion. The study will monitor changes in multiple organ failure scores, focusing on lung, heart, kidney, liver, and blood function over seven days after the infection source has been controlled. Researchers will track survival rates at 28 and 90 days, changes in organ failure severity by day 5, and the presence of multi-organ failure on day 7.
Treatment being tested: Pentaglobin is an immunoglobulin preparation containing antibodies that help enhance the immune response to fight infections. It works by supporting the immune system in clearing bacteria and reducing inflammation.
Study on the Effects of Landiolol Hydrochloride for Patients with Microcirculatory Issues During Septic Shock
This French study examines whether landiolol hydrochloride can improve blood flow in small blood vessels and reduce heart rate in patients with septic shock experiencing rapid heartbeat.
Who can participate: Adults aged 18 or older with resuscitated and stabilized septic shock, non-compensatory sinus tachycardia requiring treatment, heart rate greater than 100 beats per minute due to sepsis, requiring norepinephrine to maintain blood pressure, and managed for at least 6 hours but less than 24 hours with stable norepinephrine dosage. Participants must have social security affiliation and provide informed consent.
Who cannot participate: Patients without microcirculatory abnormalities during septic shock, those outside the specified age range, individuals not part of the designated clinical trial groups, and patients without social security affiliation.
What the study involves: Participants will receive landiolol hydrochloride through continuous intravenous infusion for 12 hours at a dosage ranging from 0.5 to 10 micrograms per kilogram per minute. The goal is to reduce heart rate by up to 15 percent. Researchers will monitor how blood flows to the kidneys, the balance of fluids in the body, and any side effects such as heart rhythm problems or reduced blood flow to organs.
Treatment being tested: Landiolol is a beta-blocker that selectively blocks receptors in the heart, helping to slow heart rate and potentially improve blood flow to vital organs during septic shock.
Study on the Effects of Mesenchymal Stem Cells and Human Albumin Solution on Organ Failure in Patients with Severe Septic Shock
This French trial investigates whether mesenchymal stem cells can help reduce organ failure in patients with severe septic shock when given early during the condition.
Who can participate: Adults aged 18 or older with community-acquired septic shock for less than 12 hours and at least 2 organ failures other than blood pressure-related issues. This can include respiratory failure, neurological failure, kidney failure, low platelet counts, or liver failure. The septic shock must occur between Sunday evening and Thursday evening due to staff availability. Women under 60 must have a negative pregnancy test and use effective contraception. Patients must be affiliated with a social security scheme.
Who cannot participate: Patients in septic shock for more than 12 hours, those with less than two organ failures other than blood pressure issues, and patients not in intensive care are excluded.
What the study involves: Participants will receive mesenchymal stem cells through intravenous solution in the early phase of septic shock. The primary measure is the SOFA score, which assesses organ function, checked at day 7 or earlier if discharged or in the event of death. Secondary evaluations include days without respiratory assistance, medications to support blood pressure, or kidney replacement therapy by day 28, as well as overall length of ICU and hospital stay. Follow-up assessments monitor adverse events for up to 90 days after treatment.
Treatment being tested: Mesenchymal stem cells are special cells that can develop into different types of cells in the body. They are believed to work by reducing inflammation and helping to protect and repair damaged tissues during septic shock.
Study on the Effects of Sodium Lactate and Saline Solutions in Patients with Septic Shock
This Czech study compares the effects of sodium lactate and 3 percent saline solution on heart function and blood circulation in patients with septic shock.
Who can participate: Adults between 18 and 90 years old with septic shock as defined by international criteria, including an acute change in SOFA score of 2 or more, need for vasopressor drugs to maintain blood pressure, and blood lactate level of 2 mmol/L or higher in the last 24 hours. Participants must likely need fluid resuscitation, shown by poor blood flow to tissues and tests indicating the heart can respond to more fluids. Informed consent is required.
Who cannot participate: Patients without septic shock, those not needing fluid resuscitation, individuals outside the specified age range, and those belonging to vulnerable populations are excluded.
What the study involves: Participants will be randomly assigned to receive either 0.5M sodium lactate or 3 percent saline solution administered intravenously at 3 ml per kg of body weight over 30 minutes. The study will monitor how these treatments affect heart function and blood pressure at the start of infusion, 30 minutes, and 60 minutes after the start. Laboratory tests will compare blood gases and electrolyte levels between the two groups.
Treatments being tested: Sodium lactate provides lactate ions that can be converted to bicarbonate in the liver, helping to correct acid-base imbalances. Saline solution increases sodium concentration in the blood, helping to restore fluid balance and improve blood pressure.
Study on Adding Vasopressin to Treat Patients with Septic Shock
This French study examines whether adding vasopressin to standard treatment with noradrenaline can improve organ function in patients with a specific type of septic shock.
Who can participate: Adults aged 18 or older with septic shock defined by proven or suspected infection requiring antibiotics, blood lactate levels greater than 2.0 mmol/L, receiving noradrenaline dosage greater than 0.3 µg/kg/min for more than one hour to maintain blood pressure, and adequate heart function shown by cardiac index of 3.0 L/min/m² or more. The noradrenaline dosage must have been at this level for less than 12 hours at enrollment. Patients must be benefiting from or affiliated with a social security system.
Who cannot participate: Patients not experiencing septic shock, those outside the specified age range, individuals not part of designated clinical trial groups, and those not affiliated with a social security system.
What the study involves: Participants will receive either vasopressin or a placebo in addition to noradrenaline through intravenous infusion for a maximum of five days. The study will compare effects on organ function, with the SOFA score measured at 48 hours and day 5. Researchers will monitor various health indicators including changes in organ function, overall survival rates at 28 days, and any side effects related to treatment.
Treatment being tested: Vasopressin is a vasopressor medication that works by binding to specific receptors in the body, causing blood vessels to constrict and increasing blood pressure. It is being studied to see if it can help reduce organ failure when added to standard treatment.
Study on Landiolol Hydrochloride and Sodium Chloride for Reducing Mortality in Patients with Septic Shock and High Heart Rate
This French study investigates whether reducing heart rate with landiolol hydrochloride can improve survival rates in patients experiencing septic shock with fast heartbeat and strong heart contractions.
Who can participate: Adults aged 18 or older with septic shock defined as severe infection causing low blood pressure requiring medication, along with high lactate levels in the blood. Participants must have received between 10 and 30 milliliters per kilogram of body weight of fluid with the body not responding to more fluids, have a left ventricular ejection fraction greater than 60 percent, a heart rate of more than 95 beats per minute with stable blood pressure for more than one hour, and can be either breathing independently or with machine assistance.
Who cannot participate: Patients not hospitalized for septic shock with hypercontractility, those not experiencing rapid heartbeat, individuals outside the specified age range, patients not part of the designated clinical trial group, and those not considered part of a vulnerable population.
What the study involves: Participants will be randomly assigned to receive either landiolol hydrochloride or standard care. The medication will be administered through intravenous infusion. The study will monitor patients over 28 days to assess the impact on survival. Researchers will observe factors such as days needing heart support medications, length of time requiring mechanical breathing support, and overall hospital stay.
Treatment being tested: Landiolol is a beta-blocker that works by blocking specific receptors in the heart, helping to slow heart rate and reduce the force of heart contractions. It is being studied to determine if slowing the heart can improve survival in patients with septic shock.
Summary
These 16 clinical trials represent a comprehensive effort to improve outcomes for patients with septic shock across Europe. France leads with the highest concentration of studies, hosting 8 trials that investigate diverse therapeutic approaches including heart rate control, kidney protection, stem cell therapy, and metabolic interventions. Spain and Italy each contribute 3 trials, while Germany, Austria, Denmark, and Czechia also participate in this important research.
The trials reflect several key areas of focus in septic shock management. Multiple studies examine cardiovascular support medications, including vasopressin, norepinephrine, and beta-blockers like landiolol and ivabradine, aiming to optimize blood pressure control and heart function. Several trials investigate kidney protection strategies using albumin, nicotinamide, and L-carnitine, recognizing that kidney injury is a common and serious complication. Immune system support through immunoglobulin therapies appears in three trials, while innovative approaches include mesenchymal stem cell therapy and medications to prevent delirium.
The research emphasizes early intervention, with most trials requiring patient enrollment within 24 hours of septic shock onset. All studies share the common goal of reducing mortality and improving organ function, though they approach this challenge through different mechanisms. These ongoing trials may provide valuable insights into personalized treatment strategies for this life-threatening condition.
