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Completed

NCT Number: NCT02120521

Serum STREM and MNDA Mointoring in ICU

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tanta University hospitals

Tanta, Algharbyia, 35217, Egypt

About this study

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, patient's 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 10-12g/dl 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 beats/min), ventilatory frequency>20 breath/min or Pco2<32mmHg (unless the patient was mechanically ventilated), a white cell count ≥12×109 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 ph<7.3), hypoxaemia, prolonged prothrombin time or decrease in platelet count >50% or ≤100×109litre1, oliguria and hypotension defined as systolic arterial pressure <90mmHg or a decrease of >40mmHg. Septic shock was defined as hypotension (<90/60mmHg) in addition to sepsis syndrome persisting despite adequate fluid resuscitation and requiring intropic support

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patients staying in ICU for more than 24 hours will be included in the study.

Exclusion criteria

  • Patients received anti-inflammatory drugs or corticosteroids before admission, patients had immunosuppressive illness, patients had chronic organ failure; patients received massive blood transfusion; patients with radiation therapy and patients with previous organ transplantation will be excluded from the study.

Treatment and study plan

Primary outcomes

  1. dynamic changes of serum sTREM-1 and MNDA

    Time frame: one week

    determine the dynamic changes of serum sTREM-1 and the corresponding changes of serum MNDA and their correlation in critically ill sepsis and SIRS patients.

Secondary outcomes

  1. Survival in critically ill sepsis and SIRS patients

    Time frame: two weeks

    determine the dynamic changes of serum sTREM-1 and the corresponding changes of serum MNDA and their correlation in critically ill sepsis and SIRS patients and survival .

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

The Predictive Values of Serum STREM and Its Correlation With MNDA Monitoring in Critically Ill Patients.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 22, 2014
Registry last updated
Dec 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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