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Septic Shock clinical trials

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NCT ID: NCT03344627 Completed - Sepsis Clinical Trials

Clinical Outcome Study of High-dose Meropenem in Sepsis and Septic Shock Patients

Start date: November 27, 2017
Phase: N/A
Study type: Interventional

Sepsis and septic shock patients are considered to have a high risk of complications and death. Appropriate antimicrobial therapy plays an important role in determining outcomes in septic patients. However, pathophysiologic changes associated with critical illness have an impact on pharmacokinetics of antimicrobials. In addition, increasing bacterial resistance is also a growing concern, especially in intensive care units., Consequently, standard antimicrobial dose may not be sufficient to achieve pharmacokinetic/pharmacodynamic target in sepsis and septic shock patients. The purpose of this study is to compare a therapy between meropenem standard dose and meropenem high dose in the treatment of sepsis and septic shock

NCT ID: NCT03338569 Completed - Sepsis Clinical Trials

Vitamin C and Septic Shock

Start date: December 20, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled clinical trial to compare Vitamin C versus placebo for patients presenting to the ICU with a diagnosis of septic shock.

NCT ID: NCT03336814 Recruiting - Septic Shock Clinical Trials

Evaluation of Early Association of Terlipressin and Norepinephrine During Septic Shock; the TerliNor Study

TERLINOR
Start date: July 27, 2018
Phase: Phase 4
Study type: Interventional

In guidelines norepinephrine is the first line vasopressor recommended in case of septic shock. Use of vasopressin is recommended when norepinephrine fails to maintain a mean arterial pressure above 65mmHg or in salvage. Several studies failed to show a superiority of vasopressin over norepinephrine but none evaluated the effect of an early association on organ failure. Terlipressin is a pro-drug of vasopressin which has the same vasoconstrictor effect. We hypothesize that the early association of terlipressin and norepinephrine during septic shock reduces organ failure. This bi centric, double-blinded, randomised, controlled versus placebo study includes 40 patients. Randomisation will be stratified between centers (two university affiliated intensive care units of Assistance-Publique-Hôpitaux de Marseille, Marseille, France). All patients with septic shock needing more than 0,5µg/kg/min of norepinephrine to reach PAM objectives are randomised, after hemodynamic evaluation and optimisation, to receive continuous infusions of terlipressin (0,01mg/kg/min) or placebo (physiologic serum). The 2 groups receive steroid therapy (continuous intravenous hydrocortisone perfusion) at this time. Clinicians are blinded of perfusion used. Use of terlipressin remains possible in salvage when patients need more of 1µg/kg/min of norepinephrine on physician's decision. Patients with acute ischemic or septic heart failure are excluded of the study. Primary objective is sepsis related Sequential Organ Failure Assessment (SOFA) score difference between the groups at day 3. Secondary objectives are mortality at day 28, lactates clearance in the first 48hours, renal function (evaluates with AKIN criteria) and use of renal replacement therapy.

NCT ID: NCT03335124 Terminated - Sepsis Clinical Trials

The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock

Start date: September 26, 2017
Phase: Phase 4
Study type: Interventional

The global burden of sepsis is substantial with an estimated 15 to 19 million cases per year; the vast majority of these cases occur in low income countries. New therapeutic approaches to sepsis are desperately required; considering the global burden of sepsis these interventions should be effective, cheap, safe and readily available. The aim is to study the synergistic effect of vitamin C, hydrocortisone and thiamine on survival in patients with severe sepsis and septic shock.

NCT ID: NCT03334006 Recruiting - Sepsis Clinical Trials

Prospective, Randomized Trial of Personalized Medicine With Pentaglobin® After Surgical Infectious Source Control in Patients With Peritonitis (PEPPER Trial).

PEPPER
Start date: November 20, 2017
Phase: Phase 2
Study type: Interventional

The aim of this prospective, randomized, controlled trial is to provide evidence for adjuvant IgGAM treatment with regard to 1. Improvement of patient outcomes for peritonitis. Improvement in outcome will be determined by scores such as MOF, SOFA and survival. 2. Identification of biomarkers (including immunoglobulin levels, HLA-DR, Nf-kB1 and other immunological biomarkers) to identify patient subpopulations that benefit most from IgGAM treatment. These patients will form the basis for a further randomized, controlled, double-blind Phase III trial (RCT) to demonstrate the benefit of this treatment. 3. In addition, these biomarkers could help to guide a targeted, i.e. "personalized", adjuvant therapy with Pentaglobin® (IgGAM) in the indication of peritonitis.

NCT ID: NCT03311568 Terminated - Critical Illness Clinical Trials

Microcirculatory Alterations in Critical Disease: New Ultrasound Technology

SepCease
Start date: October 31, 2017
Phase: N/A
Study type: Interventional

Aim of this study is (1) to test and further develop a new non-invasive ultrasound method, and (2) to gain new insight into microcirculatory alterations during critical disease, particularly in critical septic shock patients. Although early identification and treatment of sepsis have had top priority among the working tasks of the international 'Surviving Sepsis Campaign' society (collaboration of the Society of Critical Care Medicine and the European Society of Intensive Care Medicine) for several years, which have led to improved survival over the last two decades, there is no objective validated diagnostic test to identify or to support the clinical diagnosis at an early stage. Analogous, there is no validated monitoring system available to guide and evaluate the effects of stabilizing measurements in sepsis, or other critical disease, at the microcirculatory level. And thus, there is an enormous knowledge gap regarding dynamic changes at the microcirculatory level during sepsis and other critical disease. Goal with this study is to investigate the robustness of this new US-technology, regarding its ability to identify and monitor critical microcirculatory impairment during critical disease. The investigators believe this technology may improve early diagnosis and thus early initiation of adequate treatment in septic shock. Its mobile and non-invasive qualities, as in most ultrasound methods, substantiate its availability to a wide range of clinical settings.

NCT ID: NCT03308227 Not yet recruiting - Septic Shock Clinical Trials

Plasma and Lung Tissue Concentrations of Linezolid in Septic Shock Patients

Start date: October 20, 2017
Phase: N/A
Study type: Observational

The study measures the plasma and bronchoalveolar lavage fluid concentrations of linezolid in septic shock patients comparing with non-septic shock patients to confirm the impact of septic shock on PK/PD of linezolid.

NCT ID: NCT03308214 Completed - Septic Shock Clinical Trials

The Analysis of Factors Influencing the Vd of Imipenem in Septic Shock Patients

Start date: March 18, 2018
Phase:
Study type: Observational

The study measures the plasma concentrations of imipenem in septic shock patients and non-septic shock patients and observes hypoalbuminemia and the impact of the severity of critical illness on Vd

NCT ID: NCT03302650 Suspended - Septic Shock Clinical Trials

Angiotensin II for Septic Shock Treatment

Start date: April 1, 2019
Phase: Phase 3
Study type: Interventional

This study aims to investigate the effect of angiotensin II on microcirculation and peripheral perfusion in patients with septic shock.

NCT ID: NCT03297203 Completed - Septic Shock Clinical Trials

Innate Lymphoid Cells in Septic Shock

CriSIs
Start date: August 2, 2017
Phase: N/A
Study type: Interventional

Less than ten years after their intial description, the comprehension of Innate Lymphoid Cells (ILCs) biology is rapidly improving. They can be classified into four subgroups (ILCs 1, 2, 3 and NK cells) on the basis of their cytokine production and transcription factor expression. They seem to be players in infectious diseases in animals but their role in human anti-bacterial defense remains unknown. In this prospective work, the investigators will compare ILCs phenotyping in ICU patients managed for a septic shock, comparing them to ICU patients without any infectious disease on their inclusion. The investigators will also make a large immune mapping in all patients, to place ILCs in the global immune depressed state observed in septic patients.