300,000+ clinical trials. Find the right one.

135 active trials for Septic Shock

Effects of High-frequency Electrical Stimulation for Preventing Loss of Muscle Mass in Patients With Sepsis

Background: Electrical stimulation has been used in critical patients as an adjunct strategy of early rehabilitation. In septic or septic shock patients there are reports of only two studies in the literature, with conflicting results. Objective: To evaluate the effects of high frequency electrical stimulation in the prevention of muscle mass loss in patients admitted to the ICU with sepsis or septic shock. Methods: This is a randomized, controlled, double-blind clinical trial. Thirty-six patients with a diagnosis of sepsis or septic shock in the experimental group (high frequency electrical stimulation) and sham group will be randomized. They will be evaluated in relation to muscle mass, peripheral muscle strength and functional status. They will also be submitted to the collection of inflammatory, metabolic, damage and muscular trophism markers. Expected results: High-frequency electrical stimulation is expected to be able to prevent loss of muscle mass in patients admitted to the ICU with sepsis or septic shock. In addition, it is expected to be able to preserve strength in this population without increasing the pro-inflammatory or metabolic response.

Start: October 2018

Evaluation of Sepsis-induced Immunosuppression Base on QuantiFERON Monitor® in Septic Shock

QuantiFERON Monitor® is an immunological test evaluating the nonspecific cellular response by measuring interferon gamma (IFN?) secretions after T-cell and natural killer lymphocyte stimulation. This study aims at evaluating sepsis-induced immunosuppression base on QuantiFERON Monitor® in patients presenting to the intensive care unit for septic shock. The sponsor expects to identify sepsis-induced immunodeficiency in patients through a better understanding of cellular and adaptive immune responses.

Start: July 2020

Complications Related to Transpulmonary Thermodilution

The transpulmonary thermodilution is commonly used in patients with acute circulatory failure in the intensive care unit and for monitoring surgical patients at high risk. However, the incidence of complications and their risk factors in patients monitored by transpulmonary thermodilution has not been completely reported yet.

Start: February 2020

Methylene Blue and Microcirculation in Septic Shock

This trial aims to identify the effects of methylene blue infusion on the the micro-circulation in patients with septic shock. The investigators will evaluate various indices of micro-circulation such as: microvascular ?ow index, the flow heterogeneity index, the total vessel density, the perfused vessel density, and the proportion of perfused vessels.

Start: March 2020

Impact of Metabolite Supplementation to Restore Mitochondrial Dysfunction During Septic Shock: a Preclinical Study

Septic shock is defined as a subset of sepsis with severe metabolism alterations, leading to organ failure. Septic shock is associated with a high mortality, around 40% according to the SEPSIS 3 definition. Metabolic alterations are responsible for lactic acidosis, and results in mitochondrial dysfunction. This study aims at evaluate the impact of exogenous metabolites on restoring mitochondrial function in septic shock patients with lactate acidosis. Mitochondrial metabolism (quantitative analysis, mitochondrial function) in intact Peripheral Blood Mononuclear Cells (PBMC) will be isolate and analyse from patients at the early phase of septic shock (admission), at day 2 and 4. Participant's medical history will be recorded: renal and liver metabolism, severity scores and outcomes and the need for supportive care in the intensive care unit (ICU) until 28 days after admission. Furthermore, the investigators will evaluate wether selected metabolites added to the cell culture medium may improve mitochondrial metabolism.

Start: March 2020

The Effect of Restrictive Fluid Management on Cardiac Function and Glycocalyx Degradation

The study aims to compare the effects of restrictive fluid management on cardiac dysfunction and vascular integrity in septic shock patients. To achieve this, patients with septic shock according to Sepsis-3 criteria admitted to several Intensive Care Units in Sweden and Denmark will be randomized to receive restrictive respectively standard fluid therapy. Blood test from these patients will be analyzed for several biomarkers of cardiac function and glycocalyx degradation. Echocardiography will also be performed to further investigate cardiac function.

Start: February 2020

Adjuvant Therapy With CytoSorb in Refractory Septic Shock

This prospective randomized single center study investigates to what extent the removal of elevated cytokine levels by hemoadsorption has a positive effect on the treatment of patients in septic shock by stabilizing the circulatory situation.

Start: January 2020

Monitoring of Piperacillin-Tazobactam and Meropenem Plasmatic Levels in Critical Patients

The aim of this study is to establish the Piperacillin-Tazobactam and Meropenem Plasmatic Levels to know if it´s necessary to make some adjustment in the recommended dose regimen.

Start: February 2020

Extracorporeal Cytokine Removal in Patients With Septic Shock in an Adult Intensive Care Unit

Goals Primary: compare changes in norepinephrine requirements before and after hemoperfusion (HP) treatment. Secondary: demonstrate the decrease in levels of IL-6 , assess the total and individual change of SEQUENTIAL ORGAN FAILURE ASSESSMENT (SOFA), establish the resolution of shock , clearance of lactate , and mortality at discharge from INTENSIVE CARE UNIT (ICU), at 30 and 60 days.

Start: December 2019

Infusion of Prostacyclin (Iloprost) vs Placebo for 72-hours in Patients With Septic Shock Suffering From Organ Failure

The purpose of this trial is to investigate the efficacy and safety of continuous intravenous administration of low dose iloprost versus placebo for 72-hours, in up to a total of 380 patients with septic shock suffering from organ failure. The study hypothesis is that iloprost may be beneficial as an endothelial rescue treatment as it is anticipated to deactivate the endothelium and restore vascular integrity in septic shock patients suffering from organ failure caused by endothelial breakdown, ultimately improving survival.

Start: October 2019

Methylene Blue as a Third-line Vasopressor in Septic Shock

A randomized, prospective study comparing ProvayBlue® to standard care with multiple sympathomimetic vasopressors.

Start: December 2019

Time to Lose the Weight? Comparison of Weight-based and Non-weight-based Vasopressors for Septic Shock

At present, there is conflicting evidence regarding outcomes in patients with septic shock receiving weight-based vasopressor (WBVP) versus non-weight-based vasopressor (NWBVP) dosing strategies. At MCMC, a weight-based strategy is in place whereas MDMC, MMMC and MRMC currently utilize a non-weight-based dosing strategy. Obese patients (BMI > 30) receiving either strategy may potentially be receiving substantially more or less vasopressor exposure compared to their non-obese (BMI < 30) counterparts. Determining total vasopressor exposure and assessing clinical outcomes would benefit our institution and others by providing optimal vasopressor dosing strategies in obese and non-obese patients. There is a difference in clinical outcomes between patients receiving weight-based and non-weight-based vasopressor dosing strategies. There is a difference in total vasopressor exposure between obese and non-obese patients utilizing WBVP and NWBVP strategies.

Start: November 2019

The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients

Surgical trauma elicits an immune response aiming to initiate healing and remove debris and damaged tissue locally at the wound site (1). This local reaction includes a considerable production of cytokines and chemokines that enters the circulation and initiate a systemic inflammatory response mediated by circulating cytokines and chemokines. This response is called systemic inflammatory immune response (SIRS) and is an aseptic systemic inflammation. Postoperative inflammation produces proinflammatory cytokines, mainly IL-6, IL1 beta, and tumor necrosis factor alfa (2). Neutrophils and emergency granulopoesis Polymorphonuclear neutrophils constitute the most abundant population of white blood cells. Their main task is to provide innate immune protection of the host from microbial attack, migrating to the site of infection, engulfing the microbes by phagocytosis, and killing the prey through attack by reactive oxygen species (ROS) and antimicrobial granule pro¬teins (22). Upon systemic infection or inflammation, e.g., sepsis or trauma, the bone marrow enters a state of emergency granulopoiesis, drenched in cytokines that augment production and survival of neutrophils for rapid delivery to the blood (23-25). Recently, advanced techniques have evolved that al¬low the isolation of different developmental stages of steady-state and emergency neutrophils, and characterization of these has just begun (26). Glycans Glycans (polysaccharides) attached to proteins and lipids on the surfaces on immune cells serve as ligands for glycan-binding proteins, lectins. Several neutrophil processes are directed by gly¬can - lectin interactions; selectin-directed rolling on the endothelium, siglec-mediated in¬hibitory signals, and activation of effector function by galectins. Many of the proteins that end up in neutrophil intra-cellular granules are highly glycosylated, but not much is known about if and how the neutrophil glycome evolves during the 'targeting-by-timing' process of differentiation and how this is affected by emergency granulopoiesis during systemic infection and inflammation. Here is a clear knowledge gap.

Start: September 2019

Observed Pharmacokinetic of Piperacillin/Tazobactam Compared to Amikacin in ICU

The pharmacokinetics of antimicrobials is profoundly modified in Intensive care unit (ICU) patients. To adapt the treatment, it is recommended to measure blood levels of antibiotics. Some antibiotics, such as amikacin, are easy to monitor, while for other molecules, such as piperacillin/tazobactam, the drug monitoring is more difficult to obtain. These two molecules have similar physicochemical characteristics (hydrophilicity) and therefore have closed pharmacokinetic properties. OPTIMA is a study aiming at criteria will be used to judge whether the pharmacokinetic (PK) parameters of amikacin are predictive of those of piperacillin and tazobactam.

Start: January 2020

Safety and Efficiency of Combined Extracorporeal Blood Purification in Neurosurgical ICU. Prospective RCT

To assess the efficiency and safety of combined extracorporeal blood purification in patients with septic shock in Neurosurgical ICU in comparison with the efficiency and safety of the continuous renal replacement therapy (CRRT).

Start: April 2018

Hemodynamic Resuscitation and Monitoring in Early Sepsis

"Hemodynamic Resuscitation and Monitoring in Early Sepsis (HERMES Study)" involves recording of patient's medical data related to that has been collected as part of his/her routine medical care in ICU. Presently there is no data from Indian ICUs on the way patients in early sepsis are resuscitated and monitored. There may exist a wide variation in clinical practice. The investigators would like to conduct an observational study in various levels of Indian ICUs, to prospectively collect data on adult patients admitted to ICU with early sepsis in a 60-day window period. Investigator would like to study the hemodynamic resuscitation and monitoring performed in these patients. In addition, Investigator would like to identify factors associated with improved outcomes and achieving the goals of the sepsis bundles in one, three and six hours. The objectives of the study is to capture the patient characteristics and hemodynamic resuscitation and monitoring practices in patients presenting with early sepsis and hypotension to Indian ICUs Investigator plan to recruit 50 -100 centers nationwide. Each center will be asked to collect data from at least 10 patients in a maximum time window of 60 days. A convenience sample of minimum 500 patients presenting to ICU with suspected sepsis and hypotension will be taken. Each Centre will guarantee the integrity of data collection and ensure timely completion of the case record forms. Each center will select a 60 day window period for patient recruitment. The start date may be anytime any time between 1st August to 15th October 2019. Therefore, the recruitment window period will end for a respective centre, anytime between 30th September and 14th December 2019, depending on the start date. All consecutive patients in the 60-day period will be screened and those eligible will be enrolled. This is an ISCCM(Indian Society of Critical Care Medicine) Research Committee funded study. The ISCCM will fund the Principal Investigator for all expenses related software development, website hosting, secretarial assistance and miscellaneous expenses related to the conduct of the study, data analysis and publication. No funding will be given to the investigators from the various participating centers for contributing data.

Start: August 2019

Treatment of Severe Infections With Mesenchymal Stem Cells

The main purpose at the early phase of septic shock on the evolution of organ failure judged by the SOFA (Sepsis Organ Failure Assessment score) score on Day 7 (or the day of death or the day of discharge from the intensive care unit if before Day 7) compared to SOFA score observed in patients in the control group. The secondary purpose is to assess the role of heterologous mesenchymal stem cells on the occurrence and duration of failure of each organ and on the mortality at day 28 and day 90. The safety of administration will be also assessed.

Start: December 2019

The Effect of Increasing the Mean Arterial Pressure on the Microcirculation and the Prognosis of Patients With Septic Shock

Background? The mean arterial pressure? MAP? is a key pressure index to improve tissue perfusion. At present, there are no surprising results of large-scale clinical studies on sublingual microcirculation. The changes of sublingual microcirculation were more severe in septic shock non-survivors than survivors. Purpose? This study is mean to increase the MAP in septic shock patients whether with chronic hypertension or not, so as to observe the change of the microcirculation and prognosis. Method? This is a single-center, randomized, prospective cohort study. Eligible patients will be allocated into chronic hypertension or denying chronic hypertension group. These patients will be treat with vasopressors to maintain MAP at 90±5 mmHg and 70±5 mmHg. Outcome? The 28-day all-cause mortality, the 90-day all-cause mortality, the 28-day without organ dysfunction days, the Changes of sublingual microcirculation, SOFA? APACHE-? score Will be recorded.

Start: December 2019

EMS Prehospital Blood Culture Collection and Antibiotic Administration: A Two-Phase Pilot Project to Reduce Mortality in Patients With Severe Sepsis and Septic Shock

This study is designed to improve the outcomes for patients suffering from severe sepsis and septic shock (SS/SS) by decreasing the time from first medical contact to antibiotic administration. This is a stepwise study that aims to demonstrate the ability of paramedics to accurately obtain blood cultures prior to hospital arrival, administer a broad spectrum antibiotic and initiate IV fluid resuscitation in patients meeting predefined criteria for SS/SS.

Start: September 2019

Steroids, Thiamine and Ascorbic Acid in Septic Shock

The objective of this project is to determine if in patients admitted to the hospital with septic shock (population), does treatment with a bundle including hydrocortisone, thiamine, and ascorbic acid improve in-hospital or 28-day mortality (primary outcomes) or surrogate markers of illness severity including: (1) ICU or hospital length-of-stay, (2) duration of invasive mechanical ventilation, (3) duration of vasopressor administration, (4) incidence and severity of ICU delirium, and (5) illness severity (secondary outcomes).

Start: December 2019