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Septic Shock clinical trials

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NCT ID: NCT01150409 Terminated - Septic Shock Clinical Trials

Hemodynamic and Inflammatory Effects of Abrupt Versus Tapered Corticosteroid Discontinuation in Septic Shock

Start date: May 2008
Phase: Phase 4
Study type: Interventional

The proposed study will evaluate the potential benefit of a tapered course of hydrocortisone compared to abrupt cessation in patients initiated on hydrocortisone for septic shock. The study will include adult patients in the medical intensive care unit (MICU) who meet criteria for corticosteroid therapy for septic shock according to the current MICU protocol.All patients will receive 7 days of hydrocortisone (50mg/Q6hrs) as part of the routine management of septic shock, before being randomly assigned to receive hydrocortisone taper versus no taper. The primary study endpoint is the incidence of hypotension within 7 days after randomization. Secondary endpoints will include incidence of adrenal insufficiency, and changes in the inflammatory status (assessed by cytokine measurements) before, during, and after corticosteroid discontinuation. The cytokines to be measured include IL-1, IL-6, IL-9, IL-10, and TNF. Since there has not been a randomized clinical trial to investigate the potential benefit of weaning septic patients off low-dose hydrocortisone as opposed to stopping abruptly, this study has potential to change clinical practice by leading to a consistent approach of corticosteroid discontinuation and to a better understanding of their impact on the inflammatory modulation in septic shock.

NCT ID: NCT01149278 Completed - Septic Shock Clinical Trials

Assessment of Two Levels of Arterial Pressure on Survival in Patients With Septic Shock

SEPSISPAM
Start date: March 2010
Phase: N/A
Study type: Interventional

The ideal mean arterial pressure in patients with septic shock is unknown. The expert's recommandations have stated a target between 65 and 70 mm Hg. However the scientific basis are weak. Indead there are only few prospective studies which addressed this question without clear answer. Therefore we designed a RCT in order to assess the effect on mortality of two levels of mean arterial pressure in patients with septic shock.(800 patients, 30 centres)

NCT ID: NCT01145560 Completed - Septic Shock Clinical Trials

A Study to Compare the Efficacy and Safety of 2 Dosing Regimens of IV Infusions of AZD9773 (CytoFabâ„¢) With Placebo in Adult Patients With Severe Sepsis and/or Septic Shock

Start date: October 2010
Phase: Phase 2
Study type: Interventional

The primary purpose of this study to evaluate the effect of two different doses of AZD9773 (CytoFabâ„¢) versus placebo on ventilator free days (VFDs) over the first 28 days after the start of dosing with AZD9773 in patients with severe sepsis and/or septic shock, who are already receiving appropriate standard of care treatment for sepsis.

NCT ID: NCT01144624 Completed - Septic Shock Clinical Trials

A Study to Assess Safety,and Tolerability of 2 Doses of AZD9773 (CytoFabâ„¢) in Japanese With Severe Sepsis/Septic Shock

Start date: July 2010
Phase: Phase 2
Study type: Interventional

The two co-primary objectives of this study are to assess in Japanese patients with severe sepsis and/or septic shock: 1) the safety and tolerability of two different doses of intravenous AZD9773 and 2) the PK of AZD9773. The secondary objective is to make a preliminary assessment of the pharmacodynamics of two different doses of intravenous AZD9773 in Japanese patients with severe sepsis and/or septic shock.

NCT ID: NCT01139489 Completed - Sepsis Clinical Trials

Safety and Efficacy of Procalcitonin Guided Antibiotic Therapy in Adult Intensive Care Units (ICU's)

SAPS
Start date: November 2009
Phase: N/A
Study type: Interventional

This is a randomized controlled trial comparing standard-of-care therapy of infections in critically ill patients with a procalcitonin-guided approach evaluating efficacy (antibiotics consumption) and safety (mortality).

NCT ID: NCT01106300 Completed - Critical Illness Clinical Trials

Musculoskeletal Ultrasound Study in Critical Care: Longitudinal Evaluation

MUSCLE
Start date: February 2009
Phase: N/A
Study type: Observational

Each year, 110,000 English/Welsh patients are admitted to Intensive Care Units (ICU). Many face prolonged disability as a result. Over two thirds have moderate-extreme limitation in their usual activity a year later, and one-third are severely affected, being unable to continue "most activities," or to live independently. Quite why known- but severe muscle wasting isn't may play an important role. We hope to find out, measuring the degree of wasting in patients, and seeking potential causes. We shall also address the mechanism of wasting, which may reflect an altered balance of activity in muscle growth pathways and those that break muscle down. We'll do this by collecting data, taking regular blood tests, scanning the leg muscles with an ultrasound machine, and analysing small muscle samples. In addition, we'll accurately and objectively measure how impaired these patients become, using specialist questionnaires, special monitoring equipment, simple walking tests and occasional special ('Cardio-Pulmonary') exercise tests. We'll try to see how badly activity is limited, and tease out whether muscle weakness plays a significant role in this. Finally, keeping muscles working (hard to do when unconscious/drowsy/bed-bound) may maintain muscle mass, so we'll see whether maintaining muscle activity using painless electrical stimulation will help.

NCT ID: NCT01071343 Completed - Septic Shock Clinical Trials

Transcutaneous Electric Muscle Stimulation (TEMS) in Septic Patients

Start date: January 2008
Phase: N/A
Study type: Interventional

A growing number of critically ill patients survive intensive care to be discharged from hospital. However, critical illness and prolonged bedrest are associated with muscle wasting with subsequent implications for recovery of normal physical function. Thus, one year after discharge, survivors of septic shock have reported prolonged and severe impairment of physical function. Early interventions employed in the ICU to counteract loss of muscle mass may potentially improve physical outcome and reduce the overall burden of critical illness. As a potential supplement to physical therapy, transcutaneous electric muscle stimulation (TEMS) is a non-invasive method directed at maintaining skeletal muscle function through artificially induced contractions that are independent of patient efforts. TEMS has previously proven effective at preventing loss of muscle mass and force in a number of non-ICU patient groups, but has only been assessed sparsely in an ICU population where both immobilisation and systemic inflammation are present. Therefore, the aim of the present study was to assess the effect of early TEMS on muscle volume in patients admitted to the intensive care unit with septic shock. The investigators hypothesized that this intervention would preserve muscle volume during septic shock.

NCT ID: NCT01070810 Completed - Septic Shock Clinical Trials

Thiamine as a Metabolic Resuscitator in Septic Shock

Start date: February 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The major goal of this project is to determine whether the use of thiamine in patients with septic shock will result in attenuation of lactic acidosis and a more rapid reversal of shock.

NCT ID: NCT01067313 Completed - Septic Shock Clinical Trials

Continuous Hemodialysis With an Enhanced Middle Molecule Clearance Membrane

Start date: July 2008
Phase: Phase 2/Phase 3
Study type: Interventional

This study aims to demonstrate equivalence in terms of molecule removal between continuous hemodialysis using an "enhanced middle molecule clearance" membrane(Ultraflux EMiC2) and continuous hemofiltration using a standard membrane (Ultraflux AV1000S) in ICU patients requiring continuous renal replacement therapy.

NCT ID: NCT01063010 Withdrawn - Septic Shock Clinical Trials

Pilot Study of Bevacizumab (Avastin) in Patients With Septic Shock

Start date: February 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to perform a pilot study to assess the potential use of Bevacizumab (a vascular endothelial growth factor (VEGF) inhibitor) in sepsis.