Predictors of Reactive Thrombocytosis in Critically Ill Septic Patients

Sepsis Clinical Trial

Official title:

Predictors of Reactive Thrombocytosis in Critically Ill Septic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03531515
• Other study ID #: 2018-26-MD-EXP
• Status: Recruiting
• Start date: April 11, 2018
• Est. completion date: April 2019

Study information

• Verified date: May 2018
• Source: Sanjay Gandhi Postgraduate Institute of Medical Sciences
• Contact: Mohan Gurjar, MD, PDCC
• Phone: 915222495403
• Email: m.gurjar[@]rediffmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Reactive or secondary thrombocytosis is defined as abnormally high platelet count (≥4,50,000 platelets per micro-liter) in the absence of chronic myeloproliferative disease. In critically ill patients reactive thrombocytosis is not uncommon during recovery phase and an association has been seen with poor outcome and increased risk of subsequent VTE. However, not all patients with infection respond with thrombocytosis. No study has enumerated the risk factors or predictors of reactive thrombocytosis in critically ill septic patients.

Description:

All patients admitted to intensive care unit of the department of Critical Care Medicine during one year period will be screened for possible inclusion in this study. In this prospective observational study, demographic and clinical characteristics of all ICU patients who fulfill inclusion criteria will be collected along with relevant laboratory tests done for patient management routinely. ICU prognostication scores, i.e., Acute Physiologic and Chronic Health Evaluation (APACHE) II score and Sequential Organ Failure Assessment (SOFA) score will also be recorded. ICU survivors will be followed up in their routine ICU follow up clinic visits.

Sample size was estimated at 10% incidence rate of reactive thrombocytes, two sided 95% confidence interval and 4.5% margin of error of the incidence rate, sample size came out to be 171. Finally in this study investigators have targeted to include at least 180 participants. Sample size was estimated using software power analysis and sample size, 2008 (PASS-8).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adult (=18 years) ICU patients with the diagnosis of sepsis will be considered.

Exclusion Criteria:

• Age <18 years

• Pregnancy

• H/O Malignancy

• Thrombocytosis at admission

• Primary thrombocytosis

• Post-splenectomy

• Chronic inflammatory disease (e.g. Connective tissue disorders, IBD, temporal arteritis)

• Known immunosupressive condition

• Chronic infectious diseases (e.g. tuberculosis, chronic pneumonitis)

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Sepsis
• Thrombocytosis

Locations

Country	Name	City	State
India	Department of Critical Care Medicine, SGPGIMS	Lucknow	UP

Sponsors (1)

Lead Sponsor	Collaborator
Sanjay Gandhi Postgraduate Institute of Medical Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reactive or secondary thrombocytosis in critically ill septic patients	Reactive or secondary thrombocytosis (=4,50,000 platelets per micro-liter) due to the sepsis	From date of inclusion until the date of thrombocytosis or date of ICU discharge (death or alive), whichever came first, assessed up to 3 months