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Shock, Septic clinical trials

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NCT ID: NCT03685214 Recruiting - Sepsis Clinical Trials

Comparison of Balanced Crystalloids and Normal Saline in Septic Patients

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

In this prospective randomized controlled trial, investigators attempt to study the effects of acetated Ringer's solution on the prognosis and renal function of patients with sepsis in intensive care unit compared with normal saline, and provide evidence for current fluid resuscitation strategies for sepsis.

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: NCT03677102 Recruiting - Clinical trials for Sepsis, Septic Shock

Fluids in Septic Shock (FISSH)

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

Despite evidence of the physiologic benefits and possible lower mortality associated with low chloride solutions, normal saline remains the most wildly used fluid in the world. Given uncertainty about the impact of lower chloride versus higher chloride solutions on mortality, it is unlikely that clinical practice will change without new and direct randomized controlled trial (RCT) evidence. Editorials published in leading critical care journals have called for RCT's to address this important clinical question. This trial will directly compare low chloride versus normal chloride for resuscitation in septic shock on patient-important outcomes such as mortality and AKI.

NCT ID: NCT03661268 Recruiting - Septic Shock Clinical Trials

The Effect of Rapid Fluid Challenge Under Pulmonary Artery Catheter Monitoring on Physiological Indexes of Patients With Septic Shock

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

Fluid challenge is often carried out in septic shock patients. Its responsiveness usually requires invasive monitoring. The pulmonary artery catheter(PAC) is the most effective means of monitoring.To use non-invasive methods is very tempting. Investigators hypothesize that venous-to-arterial carbon dioxide difference,venous-to-arterial carbon oxygen difference, central venous-arterial carbon dioxide to arterial-venous oxygen content ratio and Central Venous SO2 variations provides feasible estimation on fluid responsiveness in septic shock patients.

NCT ID: NCT03654001 Recruiting - Septic Shock Clinical Trials

ALBumin Italian Outcome Septic Shock-BALANCED Trial (ALBIOSS-BALANCED)

ALBIOSS-BAL
Start date: May 7, 2019
Phase: Phase 3
Study type: Interventional

Septic shock is a devastating condition often observed in ICU. It is characterized by pro-inflammatory and immune responses, organ failures, high incidence of AKI and lethality. Fluid resuscitation is pivotal as supportive therapy. At present, there are no effective therapies to improve survival of such clinical condition, often characterized by a mortality as high as 40% during the first 90 days from diagnosis. This project proposes a large 2-by-2 factorial randomized clinical trial testing the efficacy of albumin and the low- chloride balanced crystalloid solutions (either Ringer Lactate, Ringer Acetate, or Crystalsol - BAL) in septic shock. The investigators have recently concluded a multicenter, randomized trial, the ALBIOS trial, in which, in a post-hoc analysis, albumin, in addition to crystalloids, reduced 90-day mortality in patients with septic shock, as compared to crystalloids alone (Caironi P et al, 2014). Crystalloids with supra-physiological chloride content may deteriorate renal perfusion, increasing the risk of acute kidney injury (AKI) and mortality.

NCT ID: NCT03649633 Recruiting - Septic Shock Clinical Trials

Vitamin C, Steroids, and Thiamine, and Cerebral Autoregulation and Functional Outcome in Septic Shock

CORVICTES-??
Start date: September 6, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This study has been approved as a nested substudy of a multicenter trial (CORVICTES, Clinicaltrials.gov Identifier: NCT03592693). The current, randomized, placebo-controlled study will compare steroids/vitamin C versus placebo/placebo in septic shock, with respect to cerebral autoregulation, biomarkers, and functional outcome. The following hypotheses will be tested: The steroids/vitamin C/thiamine intervention may result in attenuation of the septic shock-associated impairment in cerebral autoregulation; and 2) The increased frequency of intact cerebral autoregulation in the intervention group may result in more neurologic failure free days and ventilator free days during a 60-day follow-up; improved survival to hospital discharge with good functional outcome; and better patient-reported health-related outcomes at 90-day follow-up.

NCT ID: NCT03649009 Recruiting - Hyperlactatemia Clinical Trials

Thiamine As An Adjuvant Therapy For Hyperlactatemia In Septic Shock Patients

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

The study aimed to assess the effectiveness of intravenous thiamine as compared with placebo in reducing the lactate level in septic shock patients.

NCT ID: NCT03623529 Recruiting - Septic Shock Clinical Trials

A Study of LJPC-501 in Paediatric Patients With Hypotension Associated With Distributive or Vasodilatory Shock

Start date: August 2018
Phase: Phase 2
Study type: Interventional

The objective of this study is to evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP) as assessed by standard of care vasopressor dose reduction in pediatric patients with catecholamine-resistant hypotension (CRH). In addition, this study will evaluate the safety and tolerability of LJPC-501 in pediatric patients, evaluate changes in catecholamine and other vasopressor doses over time, evaluate the change in MAP over time, and the change in Pediatric Logistic Organ Dysfunction-2 (PELOD-2) scores.

NCT ID: NCT03608514 Recruiting - Clinical trials for Resolution of Septic Shock With Terlipressin

Terlipressin Alone Versus the Standard Therapy With Catecholamines for Hepatic Patients With Septic Shock- Prospective Single Center Randomized Controlled Study.

Start date: July 1, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the use of terlipressin compared to standard regimen in hepatic patients with septic shock. Another aim is to compare the mortality rate & the effects on renal functions in both groups.

NCT ID: NCT03592693 Recruiting - Shock, Septic Clinical Trials

Vitamin C, Hydrocortisone and Thiamine for Septic Shock

CORVICTES
Start date: September 6, 2018
Phase: Phase 2
Study type: Interventional

Prior data has shown that both corticosteroids and vitamin C reduce the activation of nuclear factor ƘB (NFƘB), thereby ultimately attenuating the systemic inflammatory response to sepsis/septic shock and augmenting the responsiveness to vasopressors. Therefore, the current investigators hypothesized that the combined use of vitamin C and stress-dose hydrocortisone may improve the outcomes of patients with septic shock. The investigators intend to perform a randomized, multicenter, parallel group, double-blind, placebo-controlled trial of vitamin C plus stress-dose hydrocortisone or placebo plus placebo for a total of four days after randomization of patients fulfilling the current consensus criteria for septic shock. The primary outcome will be hospital mortality, whereas the scondary outcomes will include 60-day, 28-day mortality, time to vasopressor cessation, procalcitonin clearance and change in the Sequential Organ Failure Assessment score over the first 4 days after randomization, neurologic failure-free days, and length of stay in the intensive care unit (ICU) and the hospital. Target enrollment will be 400 patients.