Mortality Due to Septic Shock Associated With Thrombocytopenia

NCT03617965 | Unknown DMC

• 1 other identifier: UCISEP0718
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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

Thrombocytopenia; Septic Shock; Sepsis Bacterial

Outcome Measures

Primary Outcomes (1)

• Survival and mortality rate

  Multivariate-adjusted Cox proportional hazards regression models will be used to study the relationship between the diagnostic groups upon admission to the ICU and the mortality rate. Cox regression models adjusted to control the influence of sociodemographic variables will be used. Kaplan-Meier graphs will be used to show differences in the risk of progression to sepsis, septic shock, and death at 30 days.

  30 days after ICU admission

Secondary Outcomes (4)

• Survival and mortality rate

  60 days after ICU admission

• Survival and mortality rate

  90 days after ICU admission

• Association between platelet levels and diagnosis

  30 days after ICU admission

• Platelet serum levels will be compared with the different clinical outcomes

  30 days after ICU admission

Study Arms (4)

Mild thrombocytopenia

Patients with a platelet count of 100 × 10e9 to 149 × 10e9/L.

Diagnostic Test: Platelet count

Moderate thrombocytopenia

Patients with a platelet count of 50 × 10e9 to 99 × 10e9/L

Diagnostic Test: Platelet count

Severe thrombocytopenia

Patients with a platelet count\<50 × 10e9/L

Diagnostic Test: Platelet count

Control group

Patients with normal platelet count (i.e.150 × 10e9 to 399 × 10e9/L)

Diagnostic Test: Platelet count

Interventions

Platelet count DIAGNOSTIC_TEST

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.

Also known as: Procalcitonin levels

Control group; Mild thrombocytopenia; Moderate thrombocytopenia; Severe thrombocytopenia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from the intensive care unit at the General Hospital of León, Guanajuato, Mexico. The sampling technique will be a convenience sampling as this is a regional urban hospital that serves a total population of approximately 1.5 million people.

You may qualify if:

• Patients diagnosed with sepsis (white blood cells \>14,000μL) and thrombocytopenia (\<150,000/μL).
• Patients who receive care in the ICU of the General Hospital of León, Gto.
• Patients with a complete file with 90-day evolution notes.

You may not qualify if:

• Patients diagnosed with cardiogenic, hypovolemic, anaphylactic and neurogenic shock
• Patients older than 80 years or younger than 18 years of age
• Patients referred from another ICU
• Patients with a diagnosis of neoplasia (i.e. hematologic and/or solid tumor)
• Pregnant women
• Patients with liver cirrhosis
• Patients with splenectomy
• Patients with thrombocytosis (i.e.\> 400,000/μL) upon admission to ICU
• Patients with previous use of drugs that could produce thrombocytopenia ( e.g. calcium carbonate, acetylsalicylic acid, clopidogrel, dipyridamole, tamoxifen, cisplatin, bexarotene, doxorubicin, and lovastatin.
• Elimination Criteria:
• Patients who do not have a follow-up at 30, 60 and 90 days.

Sponsors & Collaborators

• Universidad de Guanajuato: lead
• University Medical Center Groningen: collaborator

Study Sites (1)

Hospital General de León

León, Guanajuato, 37320, Mexico

Location

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• Williamson DR, Albert M, Heels-Ansdell D, Arnold DM, Lauzier F, Zarychanski R, Crowther M, Warkentin TE, Dodek P, Cade J, Lesur O, Lim W, Fowler R, Lamontagne F, Langevin S, Freitag A, Muscedere J, Friedrich JO, Geerts W, Burry L, Alhashemi J, Cook D; PROTECT collaborators, the Canadian Critical Care Trials Group, and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Thrombocytopenia in critically ill patients receiving thromboprophylaxis: frequency, risk factors, and outcomes. Chest. 2013 Oct;144(4):1207-1215. doi: 10.1378/chest.13-0121.

  PMID: 23788287 RESULT

• Zahar JR, Timsit JF, Garrouste-Orgeas M, Francais A, Vesin A, Descorps-Declere A, Dubois Y, Souweine B, Haouache H, Goldgran-Toledano D, Allaouchiche B, Azoulay E, Adrie C. Outcomes in severe sepsis and patients with septic shock: pathogen species and infection sites are not associated with mortality. Crit Care Med. 2011 Aug;39(8):1886-95. doi: 10.1097/CCM.0b013e31821b827c.

  PMID: 21516036 RESULT

MeSH Terms

Conditions

Thrombocytopenia; Shock, Septic

Interventions

Platelet Count

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Platelet Function Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Jaime D Mondragón, MD, MS

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 7, 2018
• Study Start: August 15, 2018
• Primary Completion: November 15, 2019
• Study Completion: December 31, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)