ACTRN12610000465055
Recruiting
未知
Continuous Monitoring of Patients with Severe Sepsis or Septic Shock using SeptiCyte (registered trademark) Lab and Procalcitonin Comparator to Determine the Relationship Between Inflammatory Index and Clinical Progression and Outcome Measures
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Severe sepsis and septic shock
- Sponsor
- ImmuneXpress Pty Ltd
- Enrollment
- 70
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Aged over 18 years
- •2\.Body Mass Index \< 40
- •3\.Clinical signs and symptoms of severe sepsis or septic shock. In brief, patients must be admitted to the intensive care unit with two or more signs of systemic inflammation within the last 24 hours, with a proven or suspected source of infection and the sepsis\-induced dysfunction of at least one organ or system. The absence of positive culture results will not affect clinical diagnosis of sepsis.
- •Systemic Inflammatory Response (SIRS) Criteria: temperature \>38°C or \<36°C; heart rate \>90 beats/min; respiratory rate \>20 breathes/min or a partial pressure of carbon dioxide (PaCO2\) of \<4\.3 kPa (\<32 mm Hg) or mechanical ventilation; and a white blood cell count \<4,000 cells/mm3 (\<4 x 109 cells/L) or \>12,000 cells/mm3 (\>12 x 109 cells/L) or \>10% immature neutrophils (band forms). (Consensus from the American College of Chest Physicians/ Society of Critical Care Medicine)
- •Infection Criteria: evidence of proven or suspected infection as demonstrated by one or more of the following: white cells in a normally sterile body fluid; perforated viscus; radiographic evidence of pneumonia in association with the production of purulent sputum; a syndrome related to a high risk of infection
- •Organ/System Dysfunction Criteria:
- •Cardiovascular – systolic arterial blood pressure of less than or equal to 90 mmHg or mean arterial pressure of less than or equal to 70 mmHg for \>1 hr, despite adequate fluid resuscitation, adequate intravascular volume status or the use of vasopressors in an attempt to maintain a systolic pressure of greater than or equal to 90 mmHg or a mean arterial pressure of greater than or equal to 70 mmHg;
- •Pulmonary – partial pressure of arterial oxygen/inspired oxygen (PaO2/FiO2 ratio) less than or equal to 250 in the presence of other dysfunctional organs or systems or less than or equal to 200 if the lung is the only dysfunctional organ;
- •Renal – urine output of \<0\.5 ml/kg of body weight/ hr for 1 hour, despite adequate fluid resuscitation;
- •Unexplained Metabolic Acidosis – pH less than or equal to 7\.30 or a base deficit of greater than or equal to 5\.0 mmol/L in association with a plasma lactate level that is \>1\.5 times the upper limit of the local laboratory reference range
Exclusion Criteria
- •1\. Patients who have an autoimmune disease or other documented chronic immunological disorder e.g. systemic lupus erythmatosus (SLE), Crohn’s disease, rheumatoid arthritis, multiple sclerosis (MS), Type 1 Diabetes Mellitus
- •2\. Oncology patients receiving chemotherapy within the last 3 months
- •3\. Solid\-organ transplant recipients
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Not Applicable
Continuous monitoring of patients in and after the acute admission ward to optimize clinical pathwayspatiënten die voor verschillende redenen op de acute opname afdeling komenpatients in the Acute Admission WardNL-OMON51219Rijnstate Ziekenhuis800
Active, not recruiting
Not Applicable
Control y seguimiento de pacientes infectados por VIH-1 en tratamiento antirretroviral y en programa de mantenimiento con metadona - Estudio CometaVIH positivos en programa de mantenimiento con metadonaEUCTR2005-000307-33-ESSogaisida
Completed
Not Applicable
Continuous neuromonitoring in critically ill patientsepileptic seizuresconvulsions10039911NL-OMON34917Klinische neurofysiologie150
Recruiting
Not Applicable
Telemedicine monitoring of patients with severe aortic stenosis and planned transcatheter aortic valve implantation (TAVI) under normal conditions and when treatment capacity is limited due to crisis.I35.0Aortic (valve) stenosisDRKS00027842Charité Campus Charité Mitte200
Completed
Not Applicable
TitelSymptom monitoring with patient-reported outcomes using a web application among lung cancer patients in the Netherlands (SYMPRO-LUNG )Lung cancerLung carcinoma1002765610029107NL-OMON50136Vrije Universiteit Medisch Centrum584