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Sepsis clinical trials

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NCT ID: NCT06240585 Not yet recruiting - Clinical trials for Gastroparesis and Sepsis

Gastroparesis as an Early Sign of Sepsis

Start date: June 1, 2024
Phase:
Study type: Observational

Upper gastrointestinal tract disorders, such as gastroparesis, are common in critically ill patients in the ICU, estimated at 60%. Gastroparesis symptoms include nausea, vomiting and abdominal pain. Risk factors for the development of gastroparesis include diabetes, surgical injury to the vagus nerve (such as certain types of bariatric surgery, and in the past - surgeries for patients who suffered from peptic ulcer), use of drugs that inhibit the activity of the digestive system such as opiates, anticholinergic drugs, sepsis, as well as being bedridden and inactive - are all common conditions in critically ill patients. There are different definitions for gastroparesis. One of the accepted definitions refers to gastric residual volume (GRV) over 200 ml at one measurement. Gastroparesis is found in some studies to be associated with increased morbidity and mortality in critically ill patients. As mentioned above, it is known that sepsis is a risk factor for gastroparesis. According to our experience based on treatment of a large number of septic patients, we have the impression that often gastroparesis is an early sign for the development of sepsis. We did not find any studies that tested this hypothesis. In this study we would like to investigate whether the development of gastroparesis in critical patients in intensive care can be a predictive sign for the development of sepsis.

NCT ID: NCT06220929 Not yet recruiting - Sepsis Clinical Trials

Mecobalamin Combined With Ceftriaxone Sodium in the Treatment of Sepsis Liver Injury

Start date: January 15, 2024
Phase: Phase 4
Study type: Interventional

The previous research of our research group shows that during the course of sepsis, the pyroptosis mediated by the caspase-4/GSDMD pathway in immune cells, induced by pathogens, is the main cause of immune collapse in sepsis patients. The preliminary study of this project further reveals that sepsis combined with intrahepatic cholestasis subsequently induces a rapid hepatocyte pyroptosis mediated by the Apaf-1 pyroptosome/caspase-3/GSDME signaling pathway. The interaction of these two processes triggers liver organ failure, suggesting GSDMD/GSDME as targets for the treatment of liver damage/liver failure in sepsis . Based on high-throughput drug screening and validation in in vivo and in vitro models, it was found that the combination of the old drug mecobalamin with ceftriaxone sodium, or with thiamine, used therapeutically, can block both of these cell pyroptosis pathways. Compared with corticosteroid drugs like dexamethasone and liver-protecting drugs, they have superior effects. Patients were randomly divided into intervention and control groups, with both groups receiving standard treatment and care for sepsis (decided by the attending physician). On this basis, the following treatments were administered: Control group (n=20): intravenous saline drip/oral placebo tablets; Intervention group (n=20): intravenous drip of ceftriaxone sodium 1g per dose, twice daily (continuously for 14 days), mecobalamin injection 1mg per dose, once daily (on days 1, 2, 3, 5, 7, 9, 11, 13), with a half-hour interval between medications. From day 15 to 28, take mecobalamin tablets orally, 1mg per dose, three times a day.

NCT ID: NCT06217939 Not yet recruiting - Shock, Septic Clinical Trials

Early Intravenous Hydrocortisone in Sepsis

Start date: April 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare two timings of steroid treatment in patients with severe infection who develop low blood pressure. The main question it aims to answer is: • Which timing strategy is better between starting steroid treatment very early in the course of severe infection, or waiting until the patient does not respond to medicine that raises blood pressure according to the current guidelines? Participants will receive either early steroid treatment or placebo right after they develop low blood pressure from infection. Both participants and treating doctors will not know which treatment participants received. When blood pressure goal is not reached after a moderate dose of drugs that raise blood pressure, an open-label steroid treatment will be given to participants as indicated in the current guidelines.

NCT ID: NCT06209268 Not yet recruiting - Sepsis Clinical Trials

The Impact of Selective Vitamin D Receptor Activation on Clinical Outcomes in Septic Patients

Start date: October 1, 2024
Phase: N/A
Study type: Interventional

Sufficient serum levels of vitamin D are important for immune system regulation with protective effect against severe infection and overactivated inflammatory response in sepsis. It is also not clear what level of vitamin D in the blood would be the trigger for vitamin D administration. A more selective approach to VDR activation than cholecalciferol could have a more significant role in the clinical outcomes of patients with sepsis. A study demonstrated that low baseline serum level of vitamin D receptor (VDR) was associated with a high incidence of 28-day mortality and negatively correlated with lactate, C-reactive protein, APACHE II SOFA scores, and disease severity among patients with sepsis in an ICU setting. The role of selective vitamin D receptor activation agents (paricalcitol or maxacalcitol) was not studied in septic patients, despite its anti-inflammatory and immunomodulatory properties. Vitamin D analogs have different effects on nuclear VDRs than does calcitriol, through different response elements in various target genes, so it is possible that their effect on a patient with sepsis will be more effective than cholecalciferol. As distribution of VDRs is ubiquitous in many organs and tissues, selective VDR activation with paricalcitol may have beneficial effects in preserving organs functionality and modulating the immune response in sepsis. Hypotheses 1. The immunoregulatory, anti-inflammatory, and anti-oxidative properties of selective vitamin D receptor activator paricalcitol would result in improvement of inflammatory, endothelial function, and antioxidative parameters and clinical outcomes in groups of septic patient admitted to ICU. 2. The baseline septic patient serum 25(OH) D3 levels at admission time in ICU have influence on clinical outcomes as well as on inflammatory, endothelial function, and antioxidative parameters. 3. The inflammatory, endothelial function, and antioxidative parameters measured at ICU admission time have significant impact on clinical outcomes in septic patients. The aim The main objective of study is to test hypothesis that that selective activator of vitamin D receptors paricalcitol will improve outcomes of septic patient admitted in ICU. The study aims to investigate the effects of paricalcitol on clinical outcomes, inflammatory markers, organ dysfunction, endothelial function, vascular morphology, coagulation markers, and haemodynamic parameters. The additional objectives of the study are to test hypothesis that septic patient serum 25(OH)vitamin D3 have impact on inflammatory, endothelial function, and antioxidative parameters including protein carbonylation; and to test hypothesis that these markers and clinical outcomes are interconnected with significant impact on clinical outcomes.

NCT ID: NCT06184659 Not yet recruiting - Sepsis Clinical Trials

Empirical Meropenem Versus Piperacillin/Tazobactam for Adult Patients With Sepsis

EMPRESS
Start date: August 1, 2024
Phase: Phase 4
Study type: Interventional

The EMPRESS trial aims to test the two most commonly used antibiotics (meropenem and piperacillin/tazobactam) among intensive care patients with sepsis (blood poisoning), as the safety of these two drugs is unclear in this group of patients.

NCT ID: NCT06160115 Not yet recruiting - Clinical trials for Acute Lymphoblastic Leukemia

The Role of NK Cells to Detect Blood Infection in ALL.

Start date: February 1, 2024
Phase:
Study type: Observational

1. Assess possibility of prediction of blood stream infections in ALL patients by profiling of NK cells using flow cytometry. 2. Assess the role of NK cells in development of drug resistance post chemotherapy.

NCT ID: NCT06156072 Not yet recruiting - Sepsis Clinical Trials

Ultrasound-guided Blood Sampling Drawing for Microbiological Analysis in the Critically Ill

ECOVEN
Start date: April 2024
Phase:
Study type: Observational

This study will test the feasibility of ultrasound-guided sterile blood sampling for critically ill patients with suspected sepsis requiring blood culture. The aim of the study is to evaluate the feasibility and safety of the use of ultrasound for blood cultures in a population of patients which can present difficult venous access and requiring more than one venipuncture attempt in general clinical practice

NCT ID: NCT06124105 Not yet recruiting - Sepsis Clinical Trials

Can Urinary Partial Oxygen Pressure be an Indicator of Acute Kidney Injury in Patients With Sepsis?

Start date: March 6, 2024
Phase: N/A
Study type: Interventional

The ability of bladder urinary partial pressure, measured as a reflection of renal medullary oxygen tension, which is an indicator of the development of acute kidney injury (AKI), to predict the development of AKI at an early stage.

NCT ID: NCT06124092 Not yet recruiting - Sepsis Clinical Trials

Outcomes of Children After Hospitalization in Intensive Care Unit

APCI
Start date: March 2024
Phase:
Study type: Observational

More than 10,000 children are hospitalized in an PICU every year in Canada. While most of them will survive their PICU hospitalization and their critical illness, some children will not recover to their pre-illness level. Some may develop behavioral, physical, emotional or developmental problems and difficulties at school. All these problems are elements that are part of the Pediatric Post-Intensive Care Syndrome (PICS-p). It is important to understand the elements (risk factors) that play a role in the development of PICS-p. In Canada, there is no systematic follow-up for children after they leave the PICU. Understanding what can cause PICS-p (risk factors) and how much PICS-p has an impact on children and their family is very important to the family well-being.

NCT ID: NCT06118801 Not yet recruiting - Clinical trials for Necrotizing Enterocolitis

The Effect of Probiotics Added to the Mother's Diet on Preterm Babies

Start date: November 2023
Phase: N/A
Study type: Interventional

Abstract According to the definition by World Health Organization; births before the completion of the 37th gestational week are called, preterm birth. Preterm birth is among the most important causes of mortality and morbidity during infancy. Necrotizing enterocolitis (NEC) is the most common gastrointestinal emergency encountered in the Neonatal Intensive Care Unit. The most common risk factors are, preterm birth, enteral feeding and bacterial colonization. Late Onset Sepsis (LOS) is one of the most common causes of morbidity and mortality in the preterm infants. A healthy gut microbiota has a key role in developing and maintaining a balanced immune response and establishing the intestinal barrier in the immediate postnatal period. Probiotics come to the fore as means that may be effective in preventing NEC and LOS. Although it is widely accepted that, breast milk has its own microbiota, the origin of these bacterial populations in the milk, has not been fully understood. The new information regarding especially the anaerobic species associated with the intestinal environments that cannot be found in the aerobic environments, suggests an endogenous route to the mammary gland through the presence of the entero-mammary pathway. The aim of this project is to determine the effect of the probiotics added to the maternal diet on the incidence of encountering NEC and LOS in the preterm infants. The unique value of this project is that, 80 ml of probiotic yogurt will be given to mothers of the preterm infants, who still breastfeed their babies, for 20 days and the effects on the baby will be examined in the scope of the study. The study has been planned to be conducted as a randomized controlled study in the Neonatal Intensive Care Unit of Şanlıurfa Training and Research Hospital. The power analysis was performed with G*Power for the sample size of the study, which has an experimental/control design structure. The sample size was determined as 50 in total. Data collection tools were organized as Mother and Infant Introductory Information Form (23 questions), Mother and Infant Follow-up Form during Probiotic Implementation (7 questions). At the beginning of the study, all mothers will fill out the mother and baby introductory information form, and the mothers in the experimental group will be given 80 ml probiotic yogurt support once a day for 20 days. In addition to that, all the babies will be monitored for growth once a week, throughout the process. Their status of regular breastfeeding, whether they are diagnosed with NEC and LOS, the time of transition to oral feeding, their bilirubin levels, their status of receiving phototherapy and their discharge durations will be evaluated, and a questionnaire that consists of scale questions will be applied after the discharge. As a result of this project, it is aimed with the probiotic that will be added to maternal nutrition to reduce the encounter of NEC and LOS in preterm infants, to positively affect the intestinal microbiota by preventing dysbiosis in these infants, to protect them from very important problems such as NEC and LOS as well as accelerating the transition to oral feeding, to help them gain weight, to shorten the duration of receiving phototherapy and hospitalization by reducing the bilirubin levels.