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Septic Shock clinical trials

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NCT ID: NCT03065751 Recruiting - Septic Shock Clinical Trials

Plasmaexchange in Early Septic Shock

EXCHANGE
Start date: January 2016
Phase: N/A
Study type: Interventional

Sepsis is defined by the occurrence of a systemic inflammatory response syndrome (SIRS) in the context of infection. Unfortunately, its incidence appears to be rising, and the mortality of septic shock remains extraordinary high (> 60%). Death in sepsis arises from shock and multi organ dysfunction that are - at least in part - triggered by an inadequate response of the host's immune system to the infection. Given the injurious role of 1) this overwhelming immune response and 2) the consumption of protective plasmatic factors (e.g. vWF cleaving proteases, hemostatic factors etc.) while the disease is progressing the investigators hypothesize that early therapeutic plasma exchange (TPE) in the most severely ill individuals might improve hemodynamics, oxygenation and ultimately survival. This therapeutic strategy combines 2 major aspects in 1 procedure: 1. removal of harmful circulating molecules and 2. replacement of protective plasma proteins. The investigators designed the EXCHANGE trial to analyze in a randomized fashion the benefit of TPE as an add-on treatment to state of the art standard sepsis care. Only patients with early septic shock (< 12 hrs) and high catecholamine doses (noradrenaline > 0.4 ug/kg bodyweight/min) will be included. Those in the treatment group will receive 3 TPEs within three consecutive days. The primary outcome is 28-day all cause mortality. To show an assumed reduction from 60% to 45% in the experimental group, a sample size of 173 patients per group has been calculated. The overall sample size is therefore n=346. The recruitment period is 3 years (+3 months observation) and will be performed in 11 national centers in Germany. Secondary endpoints (including hemodynamics, oxygenation, coagulation, and microcirculation) will be assessed on day 1, 2, 3 before and after TPE and on day 4, 5, 7 and 14. Project management and data monitoring will be organized by the Hanover Clinical Trial Center and biostatistics including a web-based randomization will be performed by the Institute of biometrics (Prof. Koch) at Hannover Medical School. The investigators hope to demonstrate a potential benefit of an additive treatment approach to improve the outcome of patients suffering from an under-recognized but deadly disease.

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: NCT03038503 Recruiting - Septic Shock Clinical Trials

What Should be the Next Vasopressor for Severe Septic Shock? Methylene Blue or Terlipressin

Start date: December 2016
Phase: Phase 3
Study type: Interventional

The ICU mortality rate of patients with septic shock was still high upto 54.1%.In first 6 hours of resuscitation, the goals of resuscitation in sepsis shock after adequate fluid resuscitation is MAP ≥65 mmHg. In refractory septic shock patient, prolong shock correlate with poor outcome due to multiple organ failure. Alternative vasopressor in septic shock with catecholamine resistance has been studied such as terlipressin, methylene blue - Terlipressin (TP) mediate vasoconstriction via V1 receptors coupled to phospholipase C, and increases intracellular Ca2+ concentration - Methylene blue (MB) directly inhibits nitric oxide synthase (NOS) by inhibit the enzyme guanylate cyclase (GC)

NCT ID: NCT03037281 Completed - Sepsis Clinical Trials

Release of Nociceptin From Granulocytes in Sepsis

Start date: April 7, 2016
Phase:
Study type: Observational

Nociceptin is a protein found in the body, with a number of functions in the central nervous system, blood vessels and the gut. There is evidence that it may have a role in controlling the immune response to infection, and may act as a link between the brain and immune system. In infection, or after surgery, there is an increase in nociceptin, and subjects greater elevations of nociceptin have a poorer outcome. There is evidence that cells of the immune system may produce nociceptin, although it is not yet known which cells are capable of producing it, and what "switches on" production. This study aims to determine 1. Which cells of the immune system can produce nociceptin 2. If there is a difference in the ability to produce nociceptin between healthy volunteers and patients with severe infections

NCT ID: NCT03034174 Completed - Critical Illness Clinical Trials

Pharmacokinetics of High-dose Tigecycline in Critically Ill Patients

Start date: January 15, 2017
Phase:
Study type: Observational

The objective of this study is to describe the pharmacokinetics of tigecycline in critically ill patients receiving continuous venovenous haemodialysis (CVVHD) and to evaluate the frequency of pharmacokinetic/pharmacodynamic target attainment with high dosing strategy (200 mg loading dose and 100 mg/12h).

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: NCT03015454 Completed - Sepsis Clinical Trials

An Algorithm Driven Sepsis Prediction Biomarker

Start date: December 2016
Phase: N/A
Study type: Interventional

A sepsis early warning predictive algorithm, InSight, has been developed and validated on a large, diverse patient cohort. In this prospective study, the ability of InSight to predict severe sepsis patients is investigated. Specifically, InSight is compared with a well established severe sepsis detector in the UCSF electronic health record (EHR).

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: NCT02990546 Withdrawn - Septic Shock Clinical Trials

Midodrine in the Recovery Phase of Septic Shock

Start date: March 1, 2017
Phase: Phase 3
Study type: Interventional

The aim of this study is to investigate the role of oral midodrine in the recovery of septic shock. The investigators hypothesize that the oral drug can reduce central line days and ICU length of stay.