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Mortality Due to Septic Shock Associated With Thrombocytopenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03617965
Recruitment Status : Active, not recruiting
First Posted : August 7, 2018
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
University Medical Center Groningen
Information provided by (Responsible Party):
Jaime Daniel Mondragón Uribe, Universidad de Guanajuato

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. 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.

Condition or disease Intervention/treatment
Thrombocytopenia Septic Shock Sepsis Bacterial Diagnostic Test: Platelet count

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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mortality Due to Septic Shock Associated With Thrombocytopenia in the Intensive Care Unit
Actual Study Start Date : August 15, 2018
Estimated Primary Completion Date : November 15, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Group/Cohort Intervention/treatment
Mild thrombocytopenia
Patients with a platelet count of 100 × 10e9 to 149 × 10e9/L.
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.
Other Name: Procalcitonin levels

Moderate thrombocytopenia
Patients with a platelet count of 50 × 10e9 to 99 × 10e9/L
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.
Other Name: Procalcitonin levels

Severe thrombocytopenia
Patients with a platelet count<50 × 10e9/L
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.
Other Name: Procalcitonin levels

Control group
Patients with normal platelet count (i.e.150 × 10e9 to 399 × 10e9/L)
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.
Other Name: Procalcitonin levels




Primary Outcome Measures :
  1. Survival and mortality rate [ Time Frame: 30 days after ICU admission ]
    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.


Secondary Outcome Measures :
  1. Survival and mortality rate [ Time Frame: 60 days after ICU admission ]
    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 60 days.

  2. Survival and mortality rate [ Time Frame: 90 days after ICU admission ]
    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 90 days.

  3. Association between platelet levels and diagnosis [ Time Frame: 30 days after ICU admission ]
    Will be evaluated using a principal component analysis.

  4. Platelet serum levels will be compared with the different clinical outcomes [ Time Frame: 30 days after ICU admission ]
    The potentially associated variables will be added through the analysis of covariance (ANCOVA) or linear regression adjusted for age, sex, and diagnosis depending on the most appropriate model to assess the prognostic factors to develop sepsis.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03617965


Locations
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Mexico
Hospital General de León
León, Guanajuato, Mexico, 37320
Sponsors and Collaborators
Universidad de Guanajuato
University Medical Center Groningen
Investigators
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Principal Investigator: Jaime D Mondragón, MD, MS University Medical Center Groningen

Publications of Results:
Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.

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Responsible Party: Jaime Daniel Mondragón Uribe, Principal Investigator, Universidad de Guanajuato
ClinicalTrials.gov Identifier: NCT03617965    
Other Study ID Numbers: UCISEP0718
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Abiding by the Declaration of Helsinki, patient anonymity will be guaranteed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shock, Septic
Thrombocytopenia
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Blood Platelet Disorders
Hematologic Diseases