Platelet Indices in Prediction of Mortality in Critically Ill Septic Patients

Sepsis Clinical Trial

Official title:

Platelet Indices in Prediction of Mortality in Critically Ill Septic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04335955
• Other study ID #: Platelet Indices in sepsis
• Status: Completed
• Start date: May 1, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: November 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Platelets (PLT), a major and essential constituent of blood, plays an important role in physiological and pathological processes such as coagulation, thrombosis, inflammation and maintenance of vascular endothelial cells the integrity (1).

Platelet indices are a group of parameters that are used to measure the total amount of PLTs, PLTs morphology and proliferation kinetics (2).

The commonly used PLT indices include PLT count, mean platelet volume (MPV), platelet distribution width (PDW), and plateletcrit (PCT). The MPV refers to the ratio of PCT to PLT count. PDW is numerically equal to the coefficient of PLT volume variation, which is used to describe the dispersion of PLTs volume (3).

It is well known that platelet indices have been applied in the diagnosis of hematological system diseases. In recent years, it has been discovered that these indices are related to the severity of illness and patients' prognosis. Reduction in PLT count is an independent risk factor for critically ill patients in intensive care unit (4).

In addition, Acute Physiology and Chronic Health Evaluation II (APACHE II) System also includes thrombocytopenia as an independent risk factor for mortality (5).

In a recent research, it will be reported that MPV will be rising with interleukin-6 and C-reactive protein in septic premature infants. MPV has been used as predictor of many inflammatory diseases as MPV significantly higher on both day 1 and day 3 in neonatal sepsis (6).

In addition, in patients with cirrhosis and ascites, elevated PDW and MPV will be accurate diagnostic predictors for ascetic fluid infection (7).

MPV and PDW will be used as biomarkers predicting the development of postoperative sepsis in colorectal cancer patient (8).

All these evidences indicated that PLT indices will be considered as indicator in a series of diseases (9).

Advantages of platelet indices are simple, available, cheap tools and routinely done in the hospital laboratory in all critical ill patients and may be a useful, sensitive tool for diagnosis and monitoring these patients especially in limited resource countries as Egypt. However, whether PLT indices are correlated with procalcitonin in assessment the severity of illness is still under research in septic patients

Description:

Blood will be drawn from the peripheral vein, arterial or a central catheter for evaluation of whole blood count, C-reactive protein (CRP), and procalcitonin serum levels. This procedure will be done at diagnosis, 3, 7, 14, 21 and 28 days of sepsis.

The following data will be recorded:

• Demographic data (age, gender and BMI) and cause of sepsis

• Procalcitonin and its correlation with changes in platelet indices

• The odds ratio (OR) for mortality in patients with normal and abnormal platelet indices.

• Sequential organ failure assessment (SOFA) scores.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 30, 2020
• Est. primary completion date: October 31, 2020
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

patients aged 18-65 years ICU stay more than 24 hours septic patients according to Third International Consensus Definitions Septic Shock patients according to Third International Consensus Definitions

Exclusion Criteria:

• Pregnant women

• Patients with active hemorrhage

• Patients with hematological diseases (including anemia, hypersplenism

• Lymphoma or leukemia

• Rheumatism, and bone marrow diseases)

• Patients who had infused with blood or platelets prior to their admission

• Patients who had used anti-platelet drugs prior to their admission

• Patients who had received radiotherapy or chemotherapy or bone marrow transplantation 1 month prior to admission.

Related Conditions & MeSH terms

• Critical Illness
• Mortality
• Platelet Indices
• Sepsis

Locations

Country	Name	City	State
Egypt	Amany Afheem	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Amany Faheem

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The correlation between platelet indices and 30 days mortality among critically ill septic patients	The correlation between platelet indices and 30 days mortality among critically ill septic patients	within 30 days from hospital admission
Secondary	Correlation between platelet indices and Length of ICU stay (days)	Correlation between platelet indices and Length of ICU stay (days)	within 30 days from hospital admission
Secondary	Correlation between platelet indices and detection of organs dysfunction	Correlation between platelet indices and detection of organs dysfunction	within 30 days from hospital admission
Secondary	Correlation between platelet indices and procalcitonin.	Correlation between platelet indices and procalcitonin.	within 30 days from hospital admission