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Shock, Septic clinical trials

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NCT ID: NCT04143035 Active, not recruiting - Septic Shock Clinical Trials

Hemodynamic Resuscitation and Monitoring in Early Sepsis

HERMES
Start date: October 22, 2019
Phase:
Study type: Observational

"Hemodynamic Resuscitation and Monitoring in Early Sepsis (HERMES Study)" involves recording of patient's medical data related to that has been collected as part of his/her routine medical care in ICU. Presently there is no data from Indian ICUs on the way patients in early sepsis are resuscitated and monitored. There may exist a wide variation in clinical practice. The investigators would like to conduct an observational study in various levels of Indian ICUs, to prospectively collect data on adult patients admitted to ICU with early sepsis in a 60-day window period. Investigator would like to study the hemodynamic resuscitation and monitoring performed in these patients. In addition, Investigator would like to identify factors associated with improved outcomes and achieving the goals of the sepsis bundles in one, three and six hours. The objectives of the study is to capture the patient characteristics and hemodynamic resuscitation and monitoring practices in patients presenting with early sepsis and hypotension to Indian ICUs Investigator plan to recruit 50 -100 centers nationwide. Each center will be asked to collect data from at least 10 patients in a maximum time window of 60 days. A convenience sample of minimum 500 patients presenting to ICU with suspected sepsis and hypotension will be taken. Each Centre will guarantee the integrity of data collection and ensure timely completion of the case record forms. Each center will select a 60 day window period for patient recruitment. The start date may be anytime any time between 1st August to 15th October 2019. Therefore, the recruitment window period will end for a respective centre, anytime between 30th September and 14th December 2019, depending on the start date. All consecutive patients in the 60-day period will be screened and those eligible will be enrolled. This is an ISCCM(Indian Society of Critical Care Medicine) Research Committee funded study. The ISCCM will fund the Principal Investigator for all expenses related software development, website hosting, secretarial assistance and miscellaneous expenses related to the conduct of the study, data analysis and publication. No funding will be given to the investigators from the various participating centers for contributing data.

NCT ID: NCT04141410 Recruiting - Sepsis Clinical Trials

Global Longitudinal Strain Assessment in Cardiogenic Shock During Sepsis

GLASSES-1
Start date: October 21, 2019
Phase:
Study type: Observational

Cardiogenic shock is a condition of low cardiac output that represents the end of a progressive deterioration of cardiac function. The main cause is ischemic heart disease but there are several causes of non-ischemic nature including sepsis. Sepsis is characterized by a picture of organ dysfunction caused by an altered response of the body to an infection. Its most serious form is septic shock, defined as a picture of sepsis in which the underlying abnormalities in the cardiovascular system and cellular metabolism are such as to increase mortality. An organ failure correlates directly with the function of others and this interdependence is especially evident when a cardiovascular failure is established. 3 Cardiac dysfunction in sepsis can be defined as that of a syndrome characterized by low cardiac output not related to myocardial ischemia. The use of levosimendan in cardiogenic shock during sepsis was first described in a 2005 case report. Since then there have been small studies and other case reports that have shown improvements in right and left ventricular contractility, ventricular coupling, cardiopulmonary performance, global oxygen transport, renal and splanchnic perfusion when compared to dobutamine and placebo. Other beneficial effects of this drug have emerged, including an anti-inflammatory, antioxidant and antiapoptotic action with a possible protection from ischemia-reperfusion damage. The present study aims to evaluate the correct use of levosimendan, after the occurrence of cardiogenic shock on a low cardiac index has been ascertained, with the aim of weaning from inotropic drugs in infusion.

NCT ID: NCT04136080 Not yet recruiting - Septic Shock Clinical Trials

The Effect of Increasing the Mean Arterial Pressure on the Microcirculation and the Prognosis of Patients With Septic Shock

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

Background: The mean arterial pressure( MAP) is a key pressure index to improve tissue perfusion. At present, there are no surprising results of large-scale clinical studies on sublingual microcirculation. The changes of sublingual microcirculation were more severe in septic shock non-survivors than survivors. Purpose: This study is mean to increase the MAP in septic shock patients whether with chronic hypertension or not, so as to observe the change of the microcirculation and prognosis. Method: This is a single-center, randomized, prospective cohort study. Eligible patients will be allocated into chronic hypertension or denying chronic hypertension group. These patients will be treat with vasopressors to maintain MAP at 90±5 mmHg and 70±5 mmHg. Outcome: The 28-day all-cause mortality, the 90-day all-cause mortality, the 28-day without organ dysfunction days, the Changes of sublingual microcirculation, SOFA, APACHE-Ⅱ score Will be recorded.

NCT ID: NCT04134624 Terminated - Sepsis Clinical Trials

EMS Prehospital Blood Culture Collection and Antibiotic Administration: A Two-Phase Pilot Project to Reduce Mortality in Patients With Severe Sepsis and Septic Shock

Start date: September 11, 2019
Phase: N/A
Study type: Interventional

This study is designed to improve the outcomes for patients suffering from severe sepsis and septic shock (SS/SS) by decreasing the time from first medical contact to antibiotic administration. This is a stepwise study that aims to demonstrate the ability of paramedics to accurately obtain blood cultures prior to hospital arrival, administer a broad spectrum antibiotic and initiate IV fluid resuscitation in patients meeting predefined criteria for SS/SS.

NCT ID: NCT04134403 Not yet recruiting - Septic Shock Clinical Trials

Steroids, Thiamine and Ascorbic Acid in Septic Shock

STASIS
Start date: December 1, 2019
Phase: Phase 3
Study type: Interventional

The objective of this project is to determine if in patients admitted to the hospital with septic shock (population), does treatment with a bundle including hydrocortisone, thiamine, and ascorbic acid improve in-hospital or 28-day mortality (primary outcomes) or surrogate markers of illness severity including: (1) ICU or hospital length-of-stay, (2) duration of invasive mechanical ventilation, (3) duration of vasopressor administration, (4) incidence and severity of ICU delirium, and (5) illness severity (secondary outcomes).

NCT ID: NCT04130230 Recruiting - Clinical trials for Sepsis, Septic Shock

Adjuvant Use of Neostigmine in Sepsis and Septic Shock.

Start date: March 6, 2019
Phase: Phase 2
Study type: Interventional

The inflammatory response represents an important, central component of sepsis. Therefore, it is believed that blunting inflammation will decrease mortality. In vivo test series with mice that had undergone cecal ligation and puncture (recognized sepsis model), physostigmine salicylate significantly inhibited the release of various cytokines (tumor necrosis factor α, interleukin1β, and interleukin 6). These results were similar to those obtained by vagus nerve stimulation. In animal sepsis model using physostigmine not only decreased inflammation but also, diminished the decrease in blood pressure following infection. Animals treated with the peripheral choline esterase inhibitor neostigmine showed no difference compared with physostigmine-treated animals. Therefore, this study aims to investigate the efficacy of choline esterase inhibitors as adjuvant therapy in patients with sepsis or septic shock. Outcome measures include: percentage reduction in procalcitonin blood level, percentage of patients achieving significant reduction in procalcitonin levels, Mean Sequential Organ Failure Assessment score, percentage decrease in lactate dehydrogenase blood level, length of stay in hospital intensive care unit, and in hospital mortality.

NCT ID: NCT04123444 Completed - Septic Shock Clinical Trials

Infusion of Prostacyclin (Iloprost) vs Placebo for 72-hours in Patients With Septic Shock Suffering From Organ Failure

COMBAT-SHINE
Start date: October 30, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this trial is to investigate the efficacy and safety of continuous intravenous administration of low dose iloprost versus placebo for 72-hours, in up to a total of 380 patients with septic shock suffering from organ failure. The study hypothesis is that iloprost may be beneficial as an endothelial rescue treatment as it is anticipated to deactivate the endothelium and restore vascular integrity in septic shock patients suffering from organ failure caused by endothelial breakdown, ultimately improving survival.

NCT ID: NCT04114162 Recruiting - Shock, Septic Clinical Trials

Fluid Overload Quantification in Septic Shock

FOTOShock
Start date: January 1, 2020
Phase:
Study type: Observational

Fluid management in septic shock patients remain a great challenge. Insufficient fluid filling lead to hypovolemia, organ failure and increased death, whereas fluid overload was associated to an increased morbidity and mortality in several studies. Several invasive and non invasive strategies have been developed during the past years to monitor the hemodynamic state of septic shock patients, but no method has been validated to objectively quantify fluid overload in septic shock patients. The Body Composition Monitor (BCM) allow for measurement of total body water (TBW), extracellular water (ECW) and intracellular water (ICW) volumes using bioimpedancemetry. The BCW is daily used in patients who undergo renal dialysis to assess the effectiveness of fluid removal. The BCM has never been validated in septic shock patients. The aim of the study is to investigate the accuracy of the BCM to measure the variation of the TBW during a fluid challenge of 500 ml of saline during the early phase of septic shock.

NCT ID: NCT04111822 Completed - Sepsis Clinical Trials

Pilot Study on the Use of Hydrocortisone, Vitamin c and Tiamine in Patient With Sepsis and Septic Shock

Start date: October 31, 2018
Phase: Phase 3
Study type: Interventional

Due to the high incidence, mortality and short and long term complications of sepsis and septic shock, it is necessary to look for strategies to try to minimize this impact.

NCT ID: NCT04110418 Recruiting - Neonatal Sepsis Clinical Trials

Methylene Blue Versus Vasopressin Analogue for Treatment of Septic Shock in Preterm Neonate

Start date: February 19, 2019
Phase: Phase 2
Study type: Interventional

A randomized, prospective study comparing methylene blue versus terlipressin in treatment of catecholamines resistant shock in preterm neonate