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Shock, Septic clinical trials

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NCT ID: NCT03343340 Recruiting - Clinical trials for Septic Shock and Acute Kidney Injury

Early Versus Late CRRT in ACLF Patients With Septic Shock and AKI

Start date: September 25, 2017
Phase: N/A
Study type: Interventional

Consecutive patients with ACLF (Acute on Chronic Liver Failure) and septic shock with AKI (Acute Kidney Injury) who give written informed consent will be included in this prospective trial at ILBS. At baseline s, endotoxin levels, NT-Pro BNP, , urine N-GAL will be done for all patients. A 10 ml serum sample will be stored for doing a cytokine profile. Septic shock will be defined by the presence of two or more diagnostic criteria for the systemic inflammatory response syndrome, proven or suspected infection with hypotension non-responsive to adequate fluid resuscitation assessed by no evidence of stroke volume variation on flow track and need of a vasopressor to achieve a target mean arterial pressure (MAP) of ≥ 65 mm Hg. A record of CVP, IVC diameter and B-lines on ultrasound lung would also be done. Patients with age less than 18 years, severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD) pregnancy, chronic kidney disease, patients already meeting emergency criteria for immediate hemodialysis at the time of randomization as specified in the late group, patients transferred from other hospitals who have already been on hemodialysis before their arrival in the intensive care unit, extremely moribund patients with an expected life expectancy of less than 24 hours, failure to give informed consent from family members.

NCT ID: NCT03343041 Withdrawn - Bacterial Sepsis Clinical Trials

Study of Low Carbohydrate Enteral Nutrition in Patients With Bacterial Septic Shock

Start date: January 8, 2018
Phase: N/A
Study type: Interventional

This pilot study aims to test the tolerability of low-carbohydrate enteral nutrition in patients with bacterial septic shock.

NCT ID: NCT03340805 Completed - Shock, Septic Clinical Trials

Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis: A Pilot Feasibility Study

PRoMPT BOLUS
Start date: January 24, 2018
Phase: Phase 1
Study type: Interventional

The objective of this pilot study is to assess overall feasibility prior to embarking on a larger randomized pragmatic trial comparing the clinical effectiveness of fluid resuscitation with NS versus LR for pediatric patients with suspected septic shock. Necessary feasibility assessments include ensuring appropriate compliance with study fluid in each of the two arms, effectiveness of study enrollment using a pragmatic study design embedded within routine clinical practice, and acceptability of using Exception from Informed Consent (EFIC).

NCT ID: NCT03338569 Completed - Sepsis Clinical Trials

Vitamin C and Septic Shock

Start date: December 20, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled clinical trial to compare Vitamin C versus placebo for patients presenting to the ICU with a diagnosis of septic shock.

NCT ID: NCT03336814 Recruiting - Septic Shock Clinical Trials

Evaluation of Early Association of Terlipressin and Norepinephrine During Septic Shock; the TerliNor Study

TERLINOR
Start date: July 27, 2018
Phase: Phase 4
Study type: Interventional

In guidelines norepinephrine is the first line vasopressor recommended in case of septic shock. Use of vasopressin is recommended when norepinephrine fails to maintain a mean arterial pressure above 65mmHg or in salvage. Several studies failed to show a superiority of vasopressin over norepinephrine but none evaluated the effect of an early association on organ failure. Terlipressin is a pro-drug of vasopressin which has the same vasoconstrictor effect. We hypothesize that the early association of terlipressin and norepinephrine during septic shock reduces organ failure. This bi centric, double-blinded, randomised, controlled versus placebo study includes 40 patients. Randomisation will be stratified between centers (two university affiliated intensive care units of Assistance-Publique-Hôpitaux de Marseille, Marseille, France). All patients with septic shock needing more than 0,5µg/kg/min of norepinephrine to reach PAM objectives are randomised, after hemodynamic evaluation and optimisation, to receive continuous infusions of terlipressin (0,01mg/kg/min) or placebo (physiologic serum). The 2 groups receive steroid therapy (continuous intravenous hydrocortisone perfusion) at this time. Clinicians are blinded of perfusion used. Use of terlipressin remains possible in salvage when patients need more of 1µg/kg/min of norepinephrine on physician's decision. Patients with acute ischemic or septic heart failure are excluded of the study. Primary objective is sepsis related Sequential Organ Failure Assessment (SOFA) score difference between the groups at day 3. Secondary objectives are mortality at day 28, lactates clearance in the first 48hours, renal function (evaluates with AKIN criteria) and use of renal replacement therapy.

NCT ID: NCT03335124 Terminated - Sepsis Clinical Trials

The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock

Start date: September 26, 2017
Phase: Phase 4
Study type: Interventional

The global burden of sepsis is substantial with an estimated 15 to 19 million cases per year; the vast majority of these cases occur in low income countries. New therapeutic approaches to sepsis are desperately required; considering the global burden of sepsis these interventions should be effective, cheap, safe and readily available. The aim is to study the synergistic effect of vitamin C, hydrocortisone and thiamine on survival in patients with severe sepsis and septic shock.

NCT ID: NCT03333278 Completed - Sepsis Clinical Trials

The Vitamin C, Hydrocortisone and Thiamine in Patients With Septic Shock Trial

VITAMINS
Start date: May 2, 2018
Phase: Phase 2
Study type: Interventional

Sepsis has been characterised as a dysregulated host response to infection. Adjunctive therapies targeting the inflammatory cascade are being increasingly explored, although to date, have failed to demonstrate consistent benefit, and sepsis continues to manifest poor outcomes. Hospital mortality in patients with septic shock remains as high as 22% in Australia and New Zealand. From a global perspective, 31 million sepsis and 19 million severe sepsis cases are expected to be treated in hospitals all over the world per year. To date, experimental data have reported that both high dose intravenous vitamin C and corticosteroids attenuate the acceleration of the inflammatory cascade and possibly reduce the endothelial injury characteristic of sepsis, enhance the release of endogenous catecholamines and improve vasopressor responsiveness. Therefore, the investigators plan to conduct a feasibility pilot prospective, multi-centre, randomised, open-label, trial in ICU patients with septic shock to test whether the intravenous administration of high dose Vitamin C (6g/d), Thiamine (400mg/d) and Hydrocortisone (200mg/d) leads to a more rapid resolution shock and vasopressor dependence.

NCT ID: NCT03308227 Not yet recruiting - Septic Shock Clinical Trials

Plasma and Lung Tissue Concentrations of Linezolid in Septic Shock Patients

Start date: October 20, 2017
Phase: N/A
Study type: Observational

The study measures the plasma and bronchoalveolar lavage fluid concentrations of linezolid in septic shock patients comparing with non-septic shock patients to confirm the impact of septic shock on PK/PD of linezolid.

NCT ID: NCT03308214 Completed - Septic Shock Clinical Trials

The Analysis of Factors Influencing the Vd of Imipenem in Septic Shock Patients

Start date: March 18, 2018
Phase:
Study type: Observational

The study measures the plasma concentrations of imipenem in septic shock patients and non-septic shock patients and observes hypoalbuminemia and the impact of the severity of critical illness on Vd

NCT ID: NCT03302650 Suspended - Septic Shock Clinical Trials

Angiotensin II for Septic Shock Treatment

Start date: April 1, 2019
Phase: Phase 3
Study type: Interventional

This study aims to investigate the effect of angiotensin II on microcirculation and peripheral perfusion in patients with septic shock.