Viewing Study NCT02120521



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Study NCT ID: NCT02120521
Status: COMPLETED
Last Update Posted: 2014-12-16
First Post: 2014-04-18

Brief Title: Serum STREM and MNDA Mointoring in ICU
Sponsor: Tanta University
Organization: Tanta University

Study Overview

Official Title: The Predictive Values of Serum STREM and Its Correlation With MNDA Monitoring in Critically Ill Patients
Status: COMPLETED
Status Verified Date: 2014-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: A total of 120 patients will be included in the study Sixty patients are critically ill with evidence of sepsis during ICU stay sepsis group and sixty patients are critically ill without evidence of infectious organism SIRS group At admission Patients data include clinical status SOFA score central venous pressure laboratory analysis and arterial blood gas analysis are measured Routine cultures will be obtained The attending physician will evaluate the patients for sepsis severe sepsis or septic shock as long as their stay in ICU A serum level of sTREM-1 and MNDA will be monitored
Detailed Description: A total of 120 patients will be included in the study Sixty patients are critically ill with evidence of sepsis during ICU stay sepsis group and sixty patients are critically ill without evidence of infectious organism SIRS group At admission Patients data include clinical status SOFA score central venous pressure laboratory analysis and arterial blood gas analysis are measured Routine cultures will be obtained The attending physician will evaluate the patients for sepsis severe sepsis or septic shock as long as their stay in ICU A serum level of sTREM-1 and MNDA will be monitored

At admission patients age sex weight and height were Patients data that include the clinical status sequential organ failure assessment SOFA score temperature heart rate respiratory rate blood pressure central venous pressure laboratory analysis complete blood count blood urea nitrogen blood sugar serum sodium potassium calcium aspartate aminotransferase alanine aminotransferase prothrombin time albumin and CRP and arterial blood gas analysis were measured Routine cultures of suspected sites blood and urine were obtained to determine the presence of infection We attempted to maintain the patient hemoglobin level at 10-12gdl and central venous pressure at 8-12 cmH2o When needed intravascular fluid replacement blood products and inotropic or vasopressor agents were administered Each day the attending physician evaluated all the study patients for sepsis severe sepsis or septic shock as long as their stay in ICU

The signs of sepsis were body temperature 36C or 38C tachycardia 90 beatsmin ventilatory frequency20 breathmin or Pco232mmHg unless the patient was mechanically ventilated a white cell count 12109 litre-1 or 4x 109 litre-1 or 10 immature neutrophils in addition to the presence of infection Severe sepsis is a sepsis associated with evidence of organ dysfunction hypoperfusion acute alteration of mental status elevated plasma lactate unexplained metabolic acidosis arterial ph73 hypoxaemia prolonged prothrombin time or decrease in platelet count 50 or 100109litre1 oliguria and hypotension defined as systolic arterial pressure 90mmHg or a decrease of 40mmHg Septic shock was defined as hypotension 9060mmHg in addition to sepsis syndrome persisting despite adequate fluid resuscitation and requiring intropic support

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None