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Critical Illness clinical trials

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NCT ID: NCT04793568 Active, not recruiting - Clinical trials for Critically Ill Patients

Human Recombinant Interferon Gamma-1b for the Prevention of Hospital-acquired Pneumonia in Critically Ill Patients: a Double-blind, International, Phase 2, Randomized, Placebo-controlled Trial - the PREV-HAP Study

PREV-HAP
Start date: March 29, 2021
Phase: Phase 2
Study type: Interventional

PREV-HAP study is part of a larger project entitled 'Host-targeted Approaches for the Prevention and the treatment of Hospital-Acquired Pneumonia' (HAP2), funded by the European Union's H2020 research and innovation programme under grant agreement N°847782. HAP2 aims to develop stratified host-directed drugs and biomarkers to enhance the prevention and the treatment of HAP and develop precision medicine in infectious diseases. Its ambition is to revolutionize the management of HAP: capitalising on the novel concept of critical-illness related immunosuppression altering the host-pathogens interactions, the aim is to propose a complete reappraisal of the physiopathology of HAP based on the concept of respiratory dysbiosis. The main hypothesis of the PREV-HAP study is that human recombinant Interferon gamma 1b (rHuIFN-γ, Imukin) treatment can restore immunity in critically ill patients and prevent Hospital-Acquired Pneumonia. The hypothesesis is that the in vivo investigations of the host-pathogens interactions can be used for the stratification of patients into high/low risk and responders/non-responders to host-targeted prevention of hospital-acquired infections. The involvement of a state of critical-illness related immunosuppression in the susceptibility to hospital-acquired pneumonia is widely accepted, and an emerging trend is that the development of drugs for the treatment of this acquired immunosuppression will prevent infection and enhance outcomes of hospitalized patients. It has been demonstrated that the productions of IFN-γ by immune cells are decreased in critically ill patients, and that these defects are associated with the susceptibility to HAP. rHuIFN-γ has neither been tested nor is recommended as adjunctive treatment of patients with HAP. Based on these specific factors identified in the host response, it is proposed in this study to use rHuIFN-γ as novel preventive approach for HAP.

NCT ID: NCT04742673 Active, not recruiting - Critical Illness Clinical Trials

Maximizing trEatment of Neurological Dysfunction Using INtravenous Guanfacine Study

MENDING
Start date: May 4, 2021
Phase: Phase 2
Study type: Interventional

This proof-of-concept study examines whether the acute brain dysfunction that occurs in critically ill patients is improved by administration of intravenous guanfacine.

NCT ID: NCT04669444 Active, not recruiting - Critical Illness Clinical Trials

Biomarkers, Genomics, Physiology in Critically Ill and ECMO Patients

IGNITE
Start date: April 14, 2020
Phase: N/A
Study type: Interventional

Patients in end-stage cardiac failure and/or respiratory failure may be started on a rescue therapy known as Extracorporeal Membrane Oxygenation (ECMO). One of the major clinical questions is how to manage the ventilator when patients are on ECMO therapy. Ventilator Induced Lung Injury (VILI) can result from aggressive ventilation of the lung during critical illness. VILI and lung injury such as Acute Respiratory Distress Syndrome (ARDS) can further increase the total body inflammation and stress, this is known as biotrauma. Biotrauma is one of the mechanisms that causes multi-organ failure in critically ill patients. One advantage of ECMO is the ability to greatly reduce the use of the ventilator and thus VILI by taking control of the patient's oxygenation and acid-base status. By minimizing VILI during ECMO we can reduce biotrauma and thus multi-organ failure. Since the optimal ventilator settings for ECMO patients are not known, we plan to study the impact of different ventilator settings during ECMO on patient's physiology and biomarkers of inflammation and injury.

NCT ID: NCT04666948 Active, not recruiting - Vancomycin Clinical Trials

Precision Dosing of Vancomycin in Critically Ill Children

BENEFICIAL
Start date: December 28, 2020
Phase: Phase 4
Study type: Interventional

The overall objective of this project is to investigate the large-scale utility of MIPD of vancomycin at point-of-care in ICU children. This evaluation includes a comparison with the more standard approach on Clinical and patient-oriented measures.

NCT ID: NCT04637113 Active, not recruiting - Critical Illness Clinical Trials

Singapore's Health Outcomes After Critical Illness in Kids

SHACK
Start date: January 14, 2021
Phase:
Study type: Observational

What is the problem? Every year about 2.5 million children are affected by critical illness and require admission to the pediatric intensive care unit (PICU). However, both children and their parents may encounter difficulties after critical illness. Children affected physically may have difficulties in breathing, eating, and drinking. Parents have reported feeling symptoms of stress such as nightmares and excessive worries after PICU discharge. Currently, the investigators do not know when and how the problems unfold and what harm does it cause. Without this information, healthcare professionals are not equipped to support these families after PICU discharge. Research Plan? To understand how critical illness could affect the physical, emotional, and social experiences of children age 1 month to 18 years of age and their parents in the first 6 months after a PICU admission. 144 children and their parents will be followed from the time of PICU admission to 6 months after discharge. Children and their parents will complete surveys to measure physical, social, emotional and function outcomes. A total of 12 families will be interviewed at 1 and 3 months after PICU discharge. Using the data provided to map out any trend or changes in this information over time. Why is this study important? To better understand the experience and health consequences of children and their parents in the first six months after PICU admission. This information would help to identify potential areas to improve the negative consequence of children and their families after a severe illness. Results will be shared to the PICU survivors and their families, national organizations, international pediatric intensive care community to improve the experiences and health outcomes following a PICU admission.

NCT ID: NCT04631510 Active, not recruiting - Clinical trials for Intensive Care Unit Sleep Disruption

Gabapentin for Sleep in Critically Ill Patients

Start date: December 1, 2020
Phase: Early Phase 1
Study type: Interventional

Sleep disruption in the intensive care unit (ICU) is a common comorbidity associated with patient morbidity and distress. There are no recommended pharmacologic interventions for sleep promotion, and many pharmacologic solutions may actually increase the risk of adverse outcomes rather than impart benefits. Gabapentin, an anticonvulsant with applications in neuropathic pain, has been investigated for sleep promotion in various populations of outpatients. Here investigators propose a pilot study of gabapentin as a therapy for sleep disruption in the ICU. Outcomes measured will be sleep quality as measured by RCSQ (Richards-Campbell Sleep Questionnaire), wrist actigraphy, EEG, and BIS monitoring. The goal is to enroll 80 critically ill patients, 40 intubated and 40 non-intubated patients. The study will take place over 2 nights, with baseline sleep measurements occurring on the first night and gabapentin administration with repeat sleep measurements on the second night.

NCT ID: NCT04552834 Active, not recruiting - Critical Illness Clinical Trials

Alterations of the Microbiome During Critical Illness With Short and Long Term Clinical Outcomes

Start date: September 15, 2020
Phase:
Study type: Observational

This study is designed to study the variations in the microbiome among critically ill patients and the effect of admission to the medical intensive care unit (MICU) at the University of Chicago. Additionally, investigators will examine the downstream clinical effects of dysbiosis in ICU patients and how patients maybe effected long term.

NCT ID: NCT04534972 Active, not recruiting - Critical Illness Clinical Trials

Strategy to Avoid Excessive Oxygen in Major Burn Patients

SAVE-O2
Start date: April 15, 2021
Phase: Phase 3
Study type: Interventional

The objective is to determine the effectiveness of a multimodal educational intervention to reduce supplemental oxygen use in major burn patients. Investigators will also evaluate the safety and clinical effectiveness of the more targeted use of oxygen therapy.

NCT ID: NCT04534959 Active, not recruiting - Critical Illness Clinical Trials

Strategy to Avoid Excessive Oxygen for Critically Ill Trauma Patients

SAVE-O2
Start date: October 15, 2020
Phase: Phase 3
Study type: Interventional

The objective is to determine the effectiveness of a multimodal educational intervention to reduce supplemental oxygen use in critically injured patients. Investigators will also evaluate the safety and clinical effectiveness of the more targeted use of oxygen therapy.

NCT ID: NCT04476355 Active, not recruiting - Clinical trials for Intensive Care Units

Implementation of Physical Restraints Clinical Practice Guidelines for Critically Ill Patients Using the CAN-IMPLEMENT Framework

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Physical restraints (PR) are widely used in ICU around the world. Many institutions have suggested that the use of PR should be reduced. Clinical practice guidelines (CPGs) are a convenient way of packaging evidence and presenting recommendations to healthcare decision makers. There are currently no CPGs on PR in China, while other countries had, so we hope to be able to adapt existing guidelines to apply in Chinese context. We use the CAN-IMPLEMENT approach to adapt and implement the guidelines.