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Shock, Septic clinical trials

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NCT ID: NCT03085758 Completed - Septic Shock Clinical Trials

Treatment of Patients With Early Septic Shock and Bio-Adrenomedullin(ADM) Concentration > 70 pg/ml With ADRECIZUMAB

AdrenOSS-2
Start date: December 12, 2017
Phase: Phase 2
Study type: Interventional

This is a double-blind, placebo-controlled, randomized, multicenter proof of concept and dose-finding phase II study using two doses of ADRECIZUMAB in patients with early septic shock and a bio-ADM plasma concentration at admission of > 70 pg/ml.

NCT ID: NCT03085459 Completed - Septic Shock Clinical Trials

Effects of Nursing Staff on Empiric Antibiotic in Septic Shock

Start date: January 12, 2015
Phase: N/A
Study type: Observational

A retrospective, observational study was performed about the patients with septic shock who admitted into intensive care unit (ICU) from January 1, 2015 to February 29, 2016. The number of patients who received empiric antibiotic treatment within first hour after septic shock diagnosis were collected. Detailed information about clinical ladder for nursing stuff and nursing shift were collected . Clinical ladder for nursing stuff is a new definition based on education background and work experience and nurses stuff are classified into four levels. N0 was defined who got college degree or above, nurse qualification certificate and working time less than one year. N1 an N2 were defined as who got nurse qualification certificate and working time between 1~3 years and more than three years, respectively. N3 was defined who was nurse-in-charge qualification or got nurse practitioner qualification for more than five years. Compliance of empiric antibiotic treatment within first hour and evaluate the effect of nursing stuff on the compliance were calculated.

NCT ID: NCT03080038 Completed - Septic Shock Clinical Trials

SQUEEZE Trial: A Trial to Determine Whether Septic Shock Reversal is Quicker in Pediatric Patients Randomized to an Early Goal Directed Fluid Sparing Strategy vs. Usual Care

SQUEEZE
Start date: March 6, 2017
Phase: N/A
Study type: Interventional

The purpose of the SQUEEZE Trial is to determine which fluid resuscitation strategy results in the best outcomes for children treated for suspected or confirmed septic shock. In this study, eligible children will be randomized to either the 'Usual Care Arm' or the 'Fluid Sparing Arm'. Children will receive treatment according to current ACCM Septic Shock Resuscitation Guidelines, with the assigned resuscitation strategy used to guide administration of further fluid boluses as well as the timing of initiation and escalation of vasoactive medications to achieve ACCM recommended hemodynamic targets.

NCT ID: NCT03078712 Completed - Septic Shock Clinical Trials

Early Goal Directed Therapy Using a Physiological Holistic View. The ANDROMEDA-SHOCK Study

ANDROMEDA
Start date: March 1, 2017
Phase: N/A
Study type: Interventional

Septic shock is a highly lethal condition associated with a mortality risk of 30 to 60%. Optimizing tissue perfusion and oxygenation is the aim to decrease mortality and morbidity in septic shock patients. Persistent hyperlactatemia after initial resuscitation is particularly difficult to interpret, although optimizing systemic blood flow might reverse ongoing hypoperfusion. Nevertheless, if persistent hyperlactatemia is caused by non-hypoperfusion-related mechanisms, then sustained efforts aimed at increasing cardiac output (CO) could lead to detrimental effects of excessive fluids or inotropes. Another potential alternative resuscitation target is peripheral perfusion as assessed by capillary refill time (CRT), mottling score or central-to-toe temperature differences. Reversal of abnormal peripheral perfusion might represent improvement in tissue hypoperfusion with the advantage of a faster recovery than lactate. Hypothesis: Peripheral perfusion guided resuscitation in septic shock is associated with lower mortality, less organ dysfunctions, less mechanical ventilation (MV), less vasopressor load, and less renal replacement therapies than a lactate-targeted resuscitation strategy. Main Objective To test if peripheral perfusion targeted resuscitation in septic shock is associated with lower 28-day mortality than a lactate targeted resuscitation. Design: Multicenter, Parallel Assignment randomized controlled study, conducted under supervision of an independent Data Safety Monitoring Board (DSMB). Interventions: 1. Active Comparator- Peripheral Perfusion guided resuscitation 2. Active Comparator- Lactate guided resuscitation Randomization: 1:1 the randomization using a block size of eight will be stratified according to participating centers. Trial size: 400 randomized patients in 30 ICUs.

NCT ID: NCT03055455 Completed - Septic Shock Clinical Trials

Neuroimaging and Neuromonitoring in Critically Ill Children With Sepsis

Start date: February 1, 2017
Phase:
Study type: Observational

In critically ill children with severe sepsis, neurophysiologic derangements often proceed undetected and can lead to irreversible brain injury causing neurocognitive and behavioral deficits. The etiology of these impairments is unclear, however, it is likely that some of this neural injury is preventable. The overarching goal for this study is to show that acute acquired structural and microstructural brain injury occurs in critically ill children with severe sepsis, and that this injury is related to neuropsychological deficits and impaired cerebral autoregulation (CAR). Subjects will complete Magnetic resonance (MR) imaging within 2-10 days of recognition of their severe sepsis. Subjects will undergo serial interrogation of CAR for up to 10 days. CAR will be determined by the correlation of arterial blood pressure with middle cerebral artery flow velocity measured by transcranial doppler ultrasonography and cerebral oximetry derived from near-infrared spectroscopy. Subjects will also participate in a neuropsychological evaluation 6 months after enrollment to evaluate multiple domains of behavior and cognition.

NCT ID: NCT03029169 Completed - Septic Shock Clinical Trials

Propafenone Versus Amiodarone in Septic Shock

PRASE
Start date: October 23, 2017
Phase: Phase 4
Study type: Interventional

Arrhythmias 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.

NCT ID: NCT03020407 Completed - Septic Shock Clinical Trials

The Randomized Controlled Trial of Inferior Vena Cava Ultrasound-guided Fluid Management in Septic Shock Resuscitation

Start date: January 18, 2017
Phase: N/A
Study type: Interventional

The primary aim of this study is to evaluate the 30-day mortality outcome of the septic shock patients who are treated with ultrasound-assisted fluid management using change of the inferior vene cava (IVC) diameter during respiratory phases in the first 6 hours compared with those treated with "usual-care" strategy.

NCT ID: NCT03014063 Completed - Septic Shock Clinical Trials

Vasopressin Plasma Concentrations in Patients Receiving Exogenous Vasopressin Infusion for Septic Shock

Start date: November 2016
Phase:
Study type: Observational

This is a prospective observational cohort trial evaluating a single plasma vasopressin concentration in patients receiving exogenous, adjunctive vasopressin for septic shock. The trial is designed to determine whether plasma vasopressin concentration influences the likelihood of hemodynamic response to exogenous vasopressin therapy.

NCT ID: NCT03013322 Completed - Sepsis Clinical Trials

Anticholium® Per Se

Start date: January 28, 2015
Phase: N/A
Study type: Interventional

Anticholium® per Se is a randomized, double-blind, placebo-controlled, monocentric trial to assess whether the CAP can be transferred from bench to bedside. In this pilot study, 20 patients with perioperative sepsis and septic shock as a result of intra-abdominal infection are enrolled. According to randomization, participants are treated with physostigmine salicylate (verum group) or 0.9% sodium chloride (placebo group) for up to 5 days. The mean Sequential Organ Failure Assessment (SOFA) score during treatment and subsequent intensive care of up to 14 days is used as surrogate outcome (primary endpoint). Secondary outcome measures include 30- and 90-day mortality. An embedded pharmacokinetics and pharmacodynamics study investigates plasma concentrations of physostigmine and its metabolite eseroline. Further analyses will contribute to the understanding of the role of various cytokines in the pathophysiology of human sepsis. A computer-generated list is used for blocked randomization.

NCT ID: NCT02971670 Completed - Sepsis Clinical Trials

Amendment of rTSST-1 Variant Vaccine Phase 1 Clinical Trial

Start date: October 2015
Phase: Phase 1
Study type: Interventional

Toxic Shock Syndrome (TSS) a severe condition with high morbidity and mortality results from the hosts overwhelming inflammatory response and cytokine storm. Staphylococcal superantigen toxins are the main causative agents. Toxic shock syndrome toxin (TSST-1) being responsible for almost all of menstruation associated and more than 50% of all other cases. There is no specific therapy. The Phase I study BioMed0713 demonstrated the safety and tolerability of the BioMed recombinant toxic shock syndrome toxin (rTSST-1) Variant Vaccine in healthy adults. The aim of this amendment is to demonstrate prolonged safety of the BioMed rTSST-1 Variant Vaccine and to assess persistence of antibodies generated in participants. The second aim of the study is to assess boosterability of the BioMed rTSST-1 Variant Vaccine.