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Severe Septic Shock Complications

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: NCT03716895
Recruitment Status : Unknown
Verified October 2018 by Marc Vives, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta.
Recruitment status was:  Not yet recruiting
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Marc Vives, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Study Description
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Brief Summary:

Adults older than 18 years old, admitted to the ICU with a Severe Septic Shock, requiring Norepinephrine at more than 0.25mcg/kg/min, who have signed informed consent form, will be consecutively included, from december 2018 to december 2019.

The primary goal is to look for risk factors associated with an increased in lactate clearance

Secondary goals are the following:

  1. To look for risk factors associated with an increase risk of Hospital and ICU length of stay.
  2. To look for risk factors associated with an increase risk of Acute Kidney Injury.
  3. To look for risk factors associated with a decrease in days alive and free of Mechanical Ventilation, Vasopressors and Renal Replacement Therapy.
  4. To look for risk factors associated with a decrease in Ventilator-free days.
  5. To look for risk factors associated with a decrease in Vasopressor-free days.
  6. To look for risk factors associated with an increase risk of in-hospital mortality.
  7. To look for risk factors associated with an increase risk of Myocardial Infarction and myocardial injury.
  8. To look for risk factors associated with an increase risk of Acute Respiratory Distress Syndrome.
  9. To compare and validate different risk scores in our cohort.

Condition or disease
Septic Shock

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Identifying Risk Factors for Complications in Severe Septic Shock
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Lactate clearance [ Time Frame: 30 days ]
    Time from hospital arrival to documented serum lactate of less than or equal to 2 mmol/L


Secondary Outcome Measures :
  1. Days alive and free of Mechanical Ventilation, Vasopressors and Renal Replacement Therapy [ Time Frame: 28 days ]
    Number of days from the last day free of vasopressors, mechanical ventilation and Renal Replacement Therapy up to day 28. If patients dies it scores 0.

  2. Mechanical Ventilation-free days [ Time Frame: 28 days ]
    Days free of mechanical ventilation up to day 28

  3. Vasopressors-free days [ Time Frame: 28 days ]
    Days free of vasopressors up to day 28

  4. Rate of Acute Kidney Injury [ Time Frame: 28 days ]
    Kidney Disease: Improving Global Outcomes definition

  5. ICU length of stay [ Time Frame: 28 days ]
    Days in ICU

  6. Hospital length of stay [ Time Frame: 30 days ]
    Days in Hospital

  7. Rate of In-hospital Mortality [ Time Frame: 30 days ]
    Any cause mortality

  8. Rate of Acute Respiratory Distress Syndrome [ Time Frame: 28 days ]
    Berlin definition

  9. Rate of New Atrial Fibrilation [ Time Frame: 28 days ]
    New atrial fibrilation requiring treatment


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Severe Septic Shock defined by requiring norepinephrine at more than 0.25mcg/kg/min
Criteria

Inclusion Criteria:

  • Adults older than 18 years old admitted to ICU with Severe Septic Shock

Exclusion Criteria:

  • Rejecting participation by not signing informed consent form.
Contacts and Locations
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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): NCT03716895


Contacts
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Contact: Marc Vives, PhD, DESA +34972940200 marcvives50@gmail.com

Locations
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Spain
Hospital Universitari Dr Josep Trueta
Girona, Spain, 17007
Contact: Marc Vives, PhD, DESA    +34972940200    marcvives50@gmail.com   
Contact: Judit Lopez, MD    +34972940200    judit.lofe@gmail.com   
Sponsors and Collaborators
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
More Information
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Additional Information:

Publications:

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Responsible Party: Marc Vives, Clinical Research Lead. Department of Anesthesiology & Critical Care, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
ClinicalTrials.gov Identifier: NCT03716895    
Other Study ID Numbers: SSS-500
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marc Vives, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta:
Severe Septic Shock
Lactate clearance
Acute Kidney Injury
 Days alive and free
Ventilation-free days
Vasopressor-free days
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
 Infections
Systemic Inflammatory Response Syndrome
Inflammation