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Septic Shock clinical trials

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NCT ID: NCT03401398 Recruiting - Septic Shock Clinical Trials

Stress Hydrocortisone In Pediatric Septic Shock

SHIPSS
Start date: March 11, 2019
Phase: Phase 3
Study type: Interventional

SHIPSS is a multi-institutional, prospective, controlled, randomized, double-blinded interventional trial that will examine the potential benefits and risks of adjunctive hydrocortisone prescribed for children with fluid and vasoactive-inotropic refractory septic shock. It is hypothesized that adjunctive hydrocortisone will significantly reduce the incidence of new and progressive organ dysfunction (primary outcome) and proportion of children with poor outcomes, defined as death or severely impaired health-related quality of life (HRQL) (secondary outcome), as assessed at 28 days following study enrollment (randomization).

NCT ID: NCT03399032 Completed - Critical Illness Clinical Trials

Pharmacokinetics of Caspofungin

Start date: February 5, 2018
Phase:
Study type: Observational

The objective of this study is to describe the pharmacokinetics of standard doses of caspofungin in critically ill patients.

NCT ID: NCT03395951 Completed - Heart Failure Clinical Trials

Mean Systemic Filling Pressure Continuous Diuretics Critical Care Patients

Start date: October 1, 2014
Phase:
Study type: Observational

Within clinical settings observation of hemodynamic changes (e.g. mean systemic filling pressure, cardiac output) in critically ill patients with a clinical indication for deresuscitation with intravenous diuretic therapy.

NCT ID: NCT03389555 Completed - Sepsis Clinical Trials

Ascorbic Acid, Corticosteroids, and Thiamine in Sepsis (ACTS) Trial

Start date: February 9, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

In this study, we aim to determine whether the combination of Ascorbic Acid (Vitamin C), Thiamine (Vitamin B1), and Corticosteroids improves the trajectory of organ failure and reduces mortality in patients with sepsis and septic shock as compared to placebo.

NCT ID: NCT03388944 Completed - Sepsis Clinical Trials

PCT Guided Stopping of Antibiotic Therapy in Children With Sepsis

Start date: October 21, 2019
Phase: N/A
Study type: Interventional

The investigators' objective is to compare the risk of treatment failure* in children admitted to the pediatric intensive care unit (PICU) with sepsis and managed by procalcitonin guided therapy for stopping of antibiotics ('PCT- guided therapy' group) with those managed with standard practices based on the evidence based guidelines ('control' group). Children with suspected or proven sepsis will be randomized to the PCT guided group or the standard practices group and will be followed up for the outcome measures that include treatment failure and mortality. The investigators plan to enroll 560 patients over a period of 3 years. The investigators believe that the proposed study will provide the answer to reducing unnecessary antibiotic usage in the PICU without causing any harm to the patient in the form of treatment failure and/or mortality.

NCT ID: NCT03380507 Terminated - Critical Illness Clinical Trials

Evaluation of Hydrocortisone, Vitamin C and Thiamine for the Treatment of Septic Shock

HYVITS
Start date: March 17, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Despite recent medical advances, sepsis and septic shock remain a major cause of death. Sepsis is a syndrome with a wide array of physiologic, pathologic, and biochemical abnormalities. Several studies have shown vitamin C have decreased the circulating pro-inflammatory cytokines and oxidative stress.Thiamine had favorable effects on pro-inflammatory cytokines, oxidative stress and cellular hypoxia.The use of hydrocortisone in combination with vitamin C will increase the transport of vitamin C into the cells; since the pro inflammatory cytokines have shown to decrease the expression of the sodium-vitamin C transporter-2 (SVCT2) while glucocorticoids increase the SVCT2 expression. A recent small retrospective study , showed a significant decrease in mortality when patients with severe sepsis and septic shock are treated with a combination of Hydrocortisone, Vitamin C, and Thiamine. Conducting a similar study with a prospective randomized design will give clinicians all over the world more answers and will help clinicians to provide better care to millions of patients using highly safe therapeutic regimen. The objective of the current study is to explore the clinical benefits of using a combination of hydrocortisone, vitamin C, and thiamine (triple therapy) for the management of septic shock. To achieve this objective, we will compare two alternative treatment strategies, either triple therapy or usual care in patients with septic shock. First aim: To assess the effectiveness of the triple therapy for septic shock Second aim: To assess the safety of triple therapy

NCT ID: NCT03378466 Terminated - Septic Shock Clinical Trials

Heparin Anticoagulation in Septic Shock

HALO
Start date: March 12, 2018
Phase: Phase 2
Study type: Interventional

This study is a pragmatic open-label international randomized trial comparing therapeutic dose intravenous unfractionated heparin (UFH) to standard care venous thromboprophylaxis in patients diagnosed with septic shock.

NCT ID: NCT03369275 Not yet recruiting - Sepsis Clinical Trials

Cellular Immunotherapy for Septic Shock

CISS2
Start date: March 2018
Phase: Phase 2
Study type: Interventional

Septic shock is associated with substantial burden in terms of both mortality and morbidity for survivors of this illness. Pre-clinical sepsis studies suggest that mesenchymal stem (stromal) cells may modulate inflammation, enhance pathogen clearance and tissue repair and reduce death. Our team has completed a Phase I dose escalation and safety clinical trial that evaluated mesenchymal stem cells (MSCs) in patients with septic shock. The Cellular Immunotherapy for Septic Shock (CISS) trial established that MSCs appear safe and that a randomized controlled trial (RCT) is feasible. Based on these data, the investigators have planned a phase II RCT (CISS2) at several Canadian academic centres which will evaluate safety, signals for clinical efficacy, and continue to examine potential mechanisms of action and biological effects of MSCs in septic shock.

NCT ID: NCT03366220 Terminated - Septic Shock Clinical Trials

Resuscitation With Plasma in Surgical and Trauma Patients With Septic Shock

Start date: March 26, 2018
Phase: Phase 2
Study type: Interventional

There is a knowledge gap regarding the optimal initial fluid to achieve effective resuscitation and improved outcomes in septic shock. The purpose of this study is to compare initial resuscitation with plasma to initial resuscitation with balanced crystalloids.

NCT ID: NCT03356249 Completed - Sepsis Clinical Trials

Next-Generation Sequencing Diagnostics of Bacteremia in Sepsis

NextGeneSiS
Start date: March 1, 2019
Phase:
Study type: Observational

Sepsis remains a major challenge, even in modern intensive care medicine. The identification of the causative pathogen is crucial for an early optimization of the antimicrobial treatment regime in patients with sepsis. In this context, culture-based diagnostic procedures (e.g. blood cultures) represent the standard of care, although they are associated with relevant limitations. Therefore, culture independent methods (e.g. Next-Generation Sequencing (NGS)) seem to be an attractive alternative. By the identification of circulating cell-free DNA in the blood and the use of the quantitative sepsis indicating quantifier (SIQ) score, causing pathogens can be identified and potential contaminations can be excluded. The goal of the presented study is therefore, to assess the diagnostic performance of a NGS-based approach for the detection of relevant infecting organisms in a big cohort of septic patients (n=500). Moreover, the plausibility of this NGS-based approach will be estimated by a panel of independent clinical specialists, retrospectively identifying potential changes in patients´ management based on NGS results.