Field Trial of Hypotensive Versus Standard Resuscitation for Hemorrhagic Shock After Trauma
Blunt TraumaPenetrating Wound1 morePrimary Aim: To determine the feasibility and safety of hypotensive resuscitation for the early treatment of patients with traumatic shock compared to standard fluid resuscitation. Primary Hypotheses: The null hypothesis regarding feasibility is that hypotensive resuscitation will result in the same volume of early crystalloid (normal saline) fluid administration compared to standard crystalloid resuscitation. The null hypothesis regarding safety is that hypotensive resuscitation will result in the same percent of patients surviving to 24 hours after 911 call received at dispatch compared to standard fluid resuscitation. Early resuscitation is defined as all fluid given until 2 hours after arrival in the Emergency Department or until hemorrhage control is achieved in the hospital, whichever occurs earlier.
Balanced Crystalloid vs. Saline in Children With Septic Shock
Septic ShockShockFluid resuscitation is the cornerstone of pediatric shock management; current practices of fluid resuscitation in children are not evidence based. Normal saline is the preferred crystalloid recommended during initial resuscitation in shock, as the incidence of hyponatremia is lower with normal saline compared to all other fluids available and commonly used. However, normal saline has its own set of undesired physicochemical actions. Emerging data strongly indicate the increased incidence of hyperchloremia, metabolic acidosis and consequently, acute kidney injury associated with infusion of large volumes of normal saline. Balanced salt solutions or crystalloids, which have composition resembling plasma but lower chloride concentrations than normal saline, clearly decrease the risk of hyperchloremia and metabolic acidosis in adult as well as pediatric studies when used during the peri-operative period. The results favored balanced solutions in comparison to normal saline. Recent systematic reviews comparing balanced or buffered versus non-buffered fluids for surgery in adults favored the former solution as the metabolic derangements were less with the use of this type of fluid. In adult patients, the two solutions have been compared in various other settings as well such as in traumatic brain injury and in shock. The results favored balanced solutions in comparison to normal saline. However, in the non-surgical setting there is a paucity of evidence on the use of these solutions in children with shock and more evidence needs to be generated to support or refute the use of this fluid as compared to normal saline. Given this background, the investigators decided to compare the effect of two solutions on the incidence of acute kidney injury in children resuscitated with either of the two fluids. Children receiving at least one fluid bolus at 20 ml/kg in the first hour would be enrolled and followed up for the proposed outcome variables. The investigators plan to enroll 708 patients over a period of 3 years. The investigators believe that the proposed study will provide answer to the research question of which of the fluids could be preferred for resuscitation.
The Effect of Lactate Clearance Oriented Haemodynamic Therapy on the Outcome of Patients With Septic...
Septic ShockThe purpose of this study is to explore and assess possible outcome benefits of lactate clearance>30% vs ScvO2 ≥70% in 6 hours as the protocol goal that evaluated adequacy of during early resuscitation of septic shock through a single-center randomized controlled study. The investigators anticipate to collect 300-400 qualified patients with septic shock who were selected from critically ill patients admitted to the Department of Critical Care Medicine. The participants can be randomized divided into lactate clearance group and SCVO2 group. The investigators compared the treatment and the relevant parameters changed after different target. 28-day mortality, ICU and hospital lengths of stay, ventilator-free days, and new emerged organ failure were collected and compared. 28-day survival curves were drew between these two group. And the adverse events of the treatment have also been compared. Through this study, the investigators want to answer that whether lactate clearance-oriented therapy can reduce the mortality in patients with septic shock, compared with ScvO2-oriented protocolised therapy.
Targeted Tissue Perfusion Versus Macrocirculatory-guided Standard Care in Patients With Septic Shock...
Shock; SepticCritical IllnessBackground: The recommended monitoring and target levels in septic shock (SSC Guidelines 2012) including mean arterial pressure (MAP) target are not based on robust clinical data. Objective: To test, if in patients with septic shock, tissue perfusion guided (TPG) treatment strategy leads to a faster resolution of hypoperfusion than the macrocirculatory target guided standard care. Design: A prospective phase II two-parallel-group open-label randomized controlled trial Interventions: Intervention group- Targeted tissue perfusion guided (TTP) - care. Control group - Macrocirculatory - guided (MCG) care. Randomization: 1:1 stratified according to the site and presence or absence of known hypertension. Trial size: 200 randomised patients in 4 ICUs.
Propafenone Versus Amiodarone in Septic Shock
Supraventricular ArrhythmiaSeptic ShockArrhythmias accompany septic shock in increased rates than in other ICU cohorts and their presence and management are related to patient´s prognosis. 1c class antiarrhythmics are seldom administered in intensive care due to a dose dependent toxicity published in case reports and unfavourable outcome reported in a few prospective trials done on cardiology patients. The papers on 1c class antiarrhythmics do not take into consideration a complex haemodynamic assessment using echocardiography. The authors have recently presented a retrospective study on SV arrhythmias in septic shock patients demonstrating favourable effect and safety of propafenone which showed higher antiarrhythmic efficacy than amiodarone.
High Strong Ion Difference Fluid vs Hartmann's Solution on Acid-Base Status in Sepsis
Septicemic ShockThis is a research to study primarily the effect of rapidly infused high strong ion difference (SID) fluid vs Hartmann's solution in altering the pH and bicarbonate level of the patient, who is in sepsis with metabolic acidosis. Half of the study population gets high SID fluid, while the other half will get Hartmann's solution.
To Assess the Efficacy of Early Introduction of a Combination of Low Dose Vasopressin Analogue in...
Cirrhosis With Septic ShockThe consecutive patients admitted to Intensive care unit of Hepatology department of ILBS and full filling all the eligibility criteria will be enrolled in 1:1 ration by the process of randomization.- The study is an open level study. The investigators will strictly follow the randomization table to give therapy as per the intervention arm. Intervention:-the therapeutic intervention is vasopressor i.e. noradrenaline alone and terlipressin along with noradrenaline to maintain the MAP >65mm Hg. Intervention arm Arm (A) - Noradrenaline Arm (B) - Noradrenaline + low dose terlipressin
Impact of Amount of Fluid for Circulatory Resuscitation on Renal Function in Patients in Shock
ShockVolume resuscitation is the mainstay of treatment in most types of shock, especially in hemorrhagic and septic shock. Septic shock is a main cause of morbidity and mortality worldwide. Although there has been a lot of research to evaluate optimal amount and composition of fluids for volume resuscitation (e.g. colloids, crystalloids, red blood cell transfusion, albumin, fresh frozen plasma) particularly in the past decade, results remain inconclusive and to some extent contradictive. The investigators would like to contribute to the establishment of new endpoints for the guidance of shock therapy focusing on the first 24 and 48 hours, amending the currently used parameters (i.e. cardiac output, heart rate, blood pressure, central venous pressure) with new measurements (see study specific measurements). The goal is to decrease the need for renal replacement therapy, thereby eventually reducing patient morbidity and mortality.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Doses of MOTREM in Patients With...
ShockSepticThis is a randomised, double-blind, two-stage, placebo controlled study. It is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of 3 doses of MOTREM versus placebo in adult patients with septic shock.
Cellular Immunotherapy for Septic Shock: A Phase I Trial
Septic ShockThis is a Phase I open label dose escalation trial of human allogeneic bone marrow derived mesenchymal stromal cells (MSCs) for the treatment of septic shock. The main purpose of the study is to assess the safety of MSCs in patients with septic shock.