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Critical Care clinical trials

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NCT ID: NCT03683329 Recruiting - Cancer Clinical Trials

Antibiotic De-escalation in Onco-hematology Patients for Sepsis or Septic Shock

DéPOH
Start date: November 26, 2018
Phase: Phase 3
Study type: Interventional

De-escalation aims at reducing the use of broad-spectrum antibiotics and therefore the emergence of multidrug-resistant (MDR) pathogens. Observational studies suggested that this strategy seems to be safe. However, there is no adequate, direct evidence showing de-escalation of antimicrobial agents to be effective and safe for onco-hematology patients with sepsis or septic shock. Thus, randomized clinical trials are needed for testing the safety and efficiency of de-escalation of antimicrobial therapy. The investigator's hypothesis is that de-escalation of empirical antimicrobial therapy in onco-hematology patients with sepsis or septic shock is noninferior to the continuation of empirical antimicrobial therapy. The first aim of the study is to demonstrate that de-escalation is noninferior to the continuation of broad-spectrum antibiotics in terms of hospital mortality. The secondary aims are to compare the two strategies in terms of mortality, duration of antimicrobial therapy, durations of mechanical ventilation, vasopressor use, numbers of superinfections, organ failure. Antimicrobial de-escalation (ADE) of antimicrobial therapy is a strategy proposed to allow for the rational use of broad-spectrum antimicrobial therapy as the empiric treatment for infections and minimize the overall exposure to these broad-spectrum agents. The need for prompt, effective antimicrobial therapy for patients with known or suspected infections is widely accepted. This principle leads to the use of very broad-spectrum antimicrobial therapy to increase the odds that all suspected potential pathogens are adequately treated. However, the potential drawback is selection of multidrug-resistant (MDR) organisms. ADE is widely recommended in the management of antimicrobial therapy in intensive care unit (ICU) patients. The Surviving Sepsis Campaign guidelines describe and recommend the process for selecting antimicrobial therapy as commencement of antimicrobials within the first hour, antimicrobial therapy broad enough to cover all likely pathogens, and daily reassessment for potential ADE. To date, no randomized study assessing this strategy is available for this specific population of cancer critically ill patients. In a recent systematic review based on 13 observational studies and one randomized controlled trial, the authors conclude that the equipoise remains and a large randomized trial is required to assess the effect of the antibiotics de-escalation strategy on the bacterial ecosystem, on MDR carriage, and on patient outcomes.

NCT ID: NCT03431493 Recruiting - Depression Clinical Trials

Behavioral Activation-Rehabilitation to Improve Depressive Symptoms & Physical Function After Acute Respiratory Failure

BEHAB
Start date: March 2, 2018
Phase: N/A
Study type: Interventional

More and more people are surviving after receiving life support for respiratory failure in the intensive care unit, but these patients often experience problems with depression and physical functioning that lead to reduced quality of life. There is a lack of treatment for these patients, with past research suggesting that treatment may be more successful if mental and physical health are addressed at the same time. This research evaluates whether a therapy delivered via telephone and home visits, combining treatment for depression and physical rehabilitation, is feasible and might help patients recover.

NCT ID: NCT03216785 Recruiting - Critical Care Clinical Trials

SNUH MICU Cohort Study of PICS

Start date: July 1, 2017
Phase:
Study type: Observational [Patient Registry]

Prospective registry of patients admitted to the medical intensive care unit Patients discharged are followed up to 5 years after discharge

NCT ID: NCT02659995 Recruiting - Critical Care Clinical Trials

Relationship Between Blood Glucose Levels and Variability and Infections Development in Critically Ill Patient

Start date: February 2016
Phase:
Study type: Observational

Our multicenter prospective observational study aims to show the relationship between blood glucose levels and glycemic variability and the development of infections during the ICU stay and with outcome. Within the secondary endpoints, we will evaluate if a blood glucose range between 70 and 140 mg/dl is associated with an increasing surviving rate in non-diabetic critically ill patients. MATERIALS AND METHODS Multicenter study (ICUs of some Italian University Hospitals). Written informed consent will be request before the inclusion of each patient in the study; if it will not be possible, an informing module will be given to the patient's family and the informed consent will be request to the patients as soon as possible. Inclusion criteria: 300 patients consecutively admitted in each ICU from January 2016 and not later than 31/12/2018. Exclusion criteria: age < 18, end-stage disease. Data collection An Excel database will be edited with these data about each patient: age, sex, type I or II diabetes, glycated hemoglobin, at-home antidiabetic therapy; admission diagnosis, admission SAPS II score; daily insulin administration (dose and route of administration, time of start, dose at the moment of glycemic measurement and min-max daily range); steroid therapy (molecule, daily dose, date of start and stop); antibiotic therapy (molecule, daily dose, date of start and stop); daily caloric and protein intake and type of nutrition; other therapies; mechanical ventilation (date of start and stop); blood lactates (worst daily value); daily leucocytes and differential white cells count; daily SOFA score; presence of infections (suspected or confirmed; site and microorganism and eventual Multidrug Resistance pattern); presence of sepsis (following SCCM criteria); length of ICU and hospital stay; outcome (ICU and hospital mortality). Every blood glucose level measurement obtained will be registered with date and time. Glycemic variability will be evaluated in terms of: - Standard deviation (SD) - Mean Amplitude of Glycemic Excursions (MAGE); - Coefficient of Variation (CV); - Glycemic Lability Index (GLI). STATISTICAL ANALYSIS Data analysis will be performed with Kolmogorov-Smirnov test; parametric and non-parametric s tests, t-test (or Mann-Whitney test), ROC Curve, binary logistic regression. Subgroups analysis. Statistical significance: p < 0,05. SAMPLE SIZE 3300 patients.

NCT ID: NCT02587273 Recruiting - Critical Care Clinical Trials

The Pharmacokinetics of Fentanyl in Intensive Care Patients

FENTANYL06
Start date: October 2015
Phase: Phase 4
Study type: Interventional

This study is part of a project intended to develop guidelines to optimise the dosing of fentanyl in intensive care patients. This study will focus on determining: - Whether the pharmacokinetics of fentanyl change during the ICU stay. - To what extent / the degree of change in fentanyl pharmacokinetics in ICU patients. - Which factors (e.g. physiological variables) that cause such a change. - Based on simulations, determine context-sensitive half-times of fentanyl in ICU patients.

NCT ID: NCT02361021 Recruiting - Critical Care Clinical Trials

Lung Aeration During WEANing From Mechanical Ventilation Determined by Electrical Impedance Tomography and Lung Ultrasound

IWEAN
Start date: July 2015
Phase: N/A
Study type: Observational

Evaluation of lung aeration during weaning from mechanical ventilation determined by electrical impedance tomography and lung ultrasound

NCT ID: NCT02150018 Recruiting - Critical Care Clinical Trials

Effect of Non Invasive Ventilation on Lung Volumes Determined by Electrical Impedance Tomography

NIVIT
Start date: June 2014
Phase: N/A
Study type: Observational

Effect of Non Invasive Ventilation on end-expiratory lung volumes determined by electrical impedance tomography

NCT ID: NCT00772252 Recruiting - Critical Care Clinical Trials

Oxidative Stress and Microcirculation in Patient With Hepatic Failure Undergoing Liver Support Treatment

Start date: August 2008
Phase: N/A
Study type: Observational

Background: In patients undergoing hemodialysis or hemofiltration will suffer from the injury of reactive oxidative species. Oxidative stress will affect cell membrane, protein, and DNA. It will damage the cell and result in organ dysfunction. We believe that in patients, who have acute hepatic failure, undergoing plasma exchange or Molecular Absorbent Recirculating System for bridge therapy will suffer from the injury of reactive oxidative species, too. It will damage the kidney, lung, cerebral cortex, and other organs. It may result in death before the recovery of liver function or undergoing liver transplantation. Aims: 1. Investigate the severity of oxidative stress and risk factors of high oxidative stress in acute hepatic failure patient undergoing plasma exchange or Molecular Absorbent Recirculating System. 2. Investigate the microcirculation status and risk factors in acute hepatic failure patient undergoing plasma exchange or Molecular Absorbent Recirculating System. 3. Study the relationship between oxidative stress and microcirculation status. 4. Study the correlation between oxidative stress and prognosis. 5. Study the correlation between microcirculation status and prognosis.