Active clinical trials for "Systemic Inflammatory Response Syndrome"

This open-label, dose-response study will evaluate the safety and efficacy of CM4620-IE in patients with acute pancreatitis and accompanying SIRS. The study will consist of two phases. The first phase will consist of 4 female and 4 male patients (cohorts 1 and 2, respectively), enrolled concurrently, randomized in a 3:1 ratio to receive CM4620-IE plus standard of care versus standard of care alone. Planned doses for first phase will be CM4620-IE 1.0 mg/kg on Day 1 and then 1.4 mg/kg on Days 2 - 4. The second phase will consist of 8 female and 8 male patients (cohorts 3 and 4, respectively), enrolled concurrently, randomized in a 3:1 ratio to receive CM4620-IE plus standard of care versus standard of care alone. Planned doses for second phase will be CM4620-IE 2.08 mg/kg on Days 1 and 2 and then 1.6 mg/kg on Days 3 and 4. Dose escalation to second phase would only occur if needed for efficacy reasons and if no events suggesting a safety signal would occur with higher dosing. The study is not powered for the analysis of study data with inferential statisitcs as the primary purpose of the study is to explore what endpoints would be most appropriate for future trials.

Sepsis is a serious condition where there is inflammation and damage to body tissue, usually caused by an infection. This infection can lead to decreased function of vital body organs and in some cases may lead to permanent health problems or death. Much of the injury is due to endotoxin, a harmful substance produced by certain types of bacteria. An endotoxin antagonist is designed to block the effects of endotoxin. This study is designed to study the safety and efficacy when treating patients with severe sepsis.

It has been well established that only 40 to 60% of the patients hospitalized for inflammatory response syndrome (SIRS) positively respond to volume expansion (VE). The fluid responsiveness is usually estimated by assessing VE-induced change in stroke volume (SV). To guide prescriptions and possibly avoid deleterious effects of inappropriate VE, several clinical studies demonstrated that invasive dynamic indices based on heart-lung interactions permit an accurate prediction of the hemodynamic effects induced by VE. Mechanical ventilation induces cyclic changes in intrathoracic and transpulmonary pressures that transiently affect venous return, right and left ventricular preload, resulting in pronounced cyclic changes in SV in preload-dependent, but not in preload-independent patients. These cyclic changes in SV can be evaluated by the cyclic changes in arterial pulse pressure. Several studies have shown that pulse pressure variation is able to predict fluid responsiveness in patients in the operating room and intensive care unit (ICU). However, this technique requires percutaneous arterial catheterization, which is associated with several rare but serious complications (thrombosis, infections, pseudoaneurysm,hematoma, and bleeding). A method for assessing noninvasive arterial blood pressure using an electropneumatic control loop was introduced by Penaz in 1973. Briefly, the blood volume in a finger is measured and kept constant by applying corresponding external pressure. The continuously changing external pressure needed to keep the volume constant directly corresponds to the arterial pressure and, therefore can be used as continuous measurement of arterial blood pressure. Numerous studies evaluating the accuracy of this technology, e.g., Finapres™ (Ohmeda Monitoring Systems, Englewood, CO), and more recently of the Infinity CNAP™ SmartPod (Dräger Medical AG & Co.KG, Lübeck, Germany). The basic operating principle of the CNAP™ is similar to the Finapres™, but CNAP™ uses multiple control loops. It has recently been shown that CNAP provides real-time estimates of mean arterial blood pressure (MAP) comparable with those measured by an invasive intraarterial catheter system during general anaesthesia. The accuracy of the measures and the respiratory variations in pulse pressure obtained with the CNAP system have not yet been studied in ICU.

The investigators will determine the feasibility, safety and efficacy of intravenous sodium bicarbonate in reducing progression to overt acute renal failure in patients with the systemic inflammatory response syndrome, and low urine output or early acute renal impairment as defined by serum neutrophil gelatinase-associated lipocalin (NGAL).

The purpose of this study is to confirm the efficacy and safety of sivelestat in patients with acute lung injury associated with systemic inflammatory response syndrome. The results will be compared to the study with conventional treatment without sivelestat.

Infection developing in the intensive care unit is a common complication of critical illness, but notoriously difficult to diagnose. A definite diagnosis based on the most reliable tests usually is not possible for at least two days. It is unclear what the optimal management approach should be while awaiting the results of diagnostic tests. In some circumstances, broad spectrum antibiotics are started with a plan to adjust them once the results of cultures are available. Observational studies show that this results in greater antibiotic use, and the risk of superinfection and resistance. In other circumstances, antibiotics may be withheld pending the results of cultures, a strategy that leads to a delay in therapy when cultures are positive, and that may be associated with a worse clinical outcome. We undertook a randomized pilot study to address the question: "In a critically ill patient for whom clinicians are uncertain whether infection may be present, and in whom potential sites of infection have been managed by removing or changing invasive devices, can a policy of delaying antibiotic treatment until cultures are available reduce the risks of excessive antibiotic use, without increasing the risks associated with delayed therapy?" Recognizing that the question has not been formally addressed before, and that approaches to clinical management are both widely divergent and passionately held, our pilot study tested the feasibility and acceptability of undertaking a larger trial with sufficient power to determine equivalence.

This study will directly compare meropenem with standard first line antibiotic therapies in subjects entering an ICU with secondary nosocomial sepsis, or who contract sepsis while resident in an ICU.

The purpose of the study is to evaluate the real-time performance of a new host response test (SeptiCyte RAPID) for differentiating sepsis from non-infection/systemic inflammatory response syndrome among patients suspected of sepsis within the first 24 hours of intensive care unit (ICU) admission.

This study aims to evaluate the influence of age and sepsis on in vivo activity of OATP1A2 using rocuronium (ROC) as a probe and evaluating the pharmacokinetics and pharmacodynamics in ASA I-III surgical patients. Thus, adult patients without sepsis (control group, n= 12), adult patients with sepsis (sepsis group, n= 12) and elderly patients without sepsis (elderly group, n= 12), all submitted to small to medium-sized surgeries who were induced with individual doses of rocuronium, fentanyl and propofol are being investigated.

The purpose of this study is to determine the pharmacokinetic properties of two different dosage regimens of intravenous vitamin C in patients admitted to the Intensive Care Unit with life-threatening illness.