Mortality Due to Septic Shock Associated With Thrombocytopenia

NCT03617965 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2019-09-25

No results posted yet for this study

Summary

A prospective longitudinal study similar to the one performed by Claushuis and colleagues (2016) will be performed in order to further understand the epidemiology and clinical relationship between platelet levels and mortality secondary to septic shock in a different population. The primary objective is to compare the mortality due to septic shock between patients with thrombocytopenia and patients with normal platelet levels in the ICU of the General Hospital of León, Gto. The secondary objectives are to identify the association between mortality due to septic shock and mild, moderate and severe thrombocytopenia in patients admitted to the ICU at 30, 60 and 90 days.

Research questions

Is there an association between thrombocytopenia and mortality due to septic shock in patients admitted to the critical medicine service? Our hypotheses are that:

1\. Mortality from septic shock and thrombocytopenia at 30, 60 and 90 days will be higher in patients with thrombocytopenia than in patients normal platelet counts.

Is there an association between the degree of thrombocytopenia and mortality from septic shock in patients admitted to the critical medicine service? Our hypotheses are that:

1. Mortality from septic shock and thrombocytopenia at 30, 60 and 90 days will be higher in patients with mild thrombocytopenia than in patients without thrombocytopenia.
2. Mortality from septic shock and thrombocytopenia at 30, 60 and 90 days will be higher in patients with moderate thrombocytopenia than in patients without thrombocytopenia.
3. Mortality from septic shock and thrombocytopenia at 30, 60 and 90 days will be higher in patients with severe thrombocytopenia than in patients without thrombocytopenia.

Conditions

Interventions

DIAGNOSTIC_TEST

Platelet count

All patients who are admitted to the intensive care unit of this hospital and meet the inclusion criteria will be followed for 90 days. There will be a complete review of the file that includes the entire hospitalization, in order to collect demographic information, clinical, laboratory reports, and imaging reports among others. Patients who are transferred to other units due to clinical improvement will be followed peripherally by the internal medicine department and the patients who are released due to clinical improvement will be contacted via telephone or in their next outpatient consultation with an internist.

Sponsors & Collaborators

  • University Medical Center Groningen

    collaborator OTHER
  • Universidad de Guanajuato

    lead OTHER

Principal Investigators

  • Jaime D Mondragón, MD, MS · University Medical Center Groningen

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-15
Primary Completion
2019-11-15
Completion
2019-12-31

Countries

  • Mexico

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03617965 on ClinicalTrials.gov