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ASpirin for Patients With SEPsis and SeptIc Shock (ASP-SEPSIS)

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ClinicalTrials.gov Identifier: NCT01784159
Recruitment Status : Recruiting
First Posted : February 5, 2013
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Flavia Ribeiro Machado, Federal University of São Paulo

Brief Summary:

This Randomized, pragmatic, multicentric with blinding of patients and health professionals, intention-to-treat analysis has by primary endpoint to evaluate whether the aspirin use reduces the intensity of organic dysfunction measured by the variation of the SOFA score starting from the day of admission to the seventh day. Secundary endpoint: To evaluate if the aspirin use reduces the time of mechanical ventilation, length of stay in the ICU and in the hospital. In addition, to evaluate the safety of its administration regarding the occurrence of bleeding.

The data will be collected directly from the chart of the patients admitted to the ICU.

Data quality assurance will be made through periodic verification, aiming for complete and consistent data. The centers will receive periodic reports for adequacy of potentially inconsistent or incomplete data.

The baseline SOFA of patients with sepsis is 8.8 with a standard deviation of 3. The expected reduction in the control group in the SOFA at day 7 is 2 points. Considering a power of 80% and a level of significance of 0.05, it is estimated that 143 patients will be needed in each group. Estimating mortality up to D7 by 10%, will require 168 patients in each arm of the study, a total of 336 patients.

All analyzes will follow the intention-to-treat principle. We will evaluate the effect of aspirin compared to placebo on primary and binary outcomes by means of relative risks, 95% confidence intervals and chi-square tests. For continuous outcomes with normal distribution, we will present the mean difference, 95% confidence interval and P value calculated by t test. For continuous outcomes with asymmetric distribution, we will perform Wilcoxon test.


Condition or disease Intervention/treatment Phase
Sepsis Drug: Aspirin Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: placebo
Primary Purpose: Treatment
Official Title: Impact of Aspirin Use on the Severity of Organ Dysfunctions in Patients With Sepsis and Septic Shock: a Randomized, Double-blind, Placebo-controlled Trial - ASP-SEPSIS.
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock
Drug Information available for: Aspirin

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo 1tb / day/ 7days
Drug: Aspirin
Aspirin administration for 7 days
Other Name: AAS

Active Comparator: Aspirin
Intervention aspirin 200 mg/day for 7 days
Drug: Aspirin
Aspirin administration for 7 days
Other Name: AAS




Primary Outcome Measures :
  1. Difference between the Sequential Organ Failure Assessment (SOFA) Score on the seventh day of ICU stay and baseline (DeltaSOFA D7-D1). [ Time Frame: 7 days ]
    To evaluate whether the aspirin use reduces the intensity of organic dysfunction. measured by the variation of the SOFA score starting from the day of admission to the seventh day. The Sequential Organ Failure Assessment (SOFA) Score ranges between 0 and 24.


Secondary Outcome Measures :
  1. Mechanical ventilation free days; [ Time Frame: 28 days ]
    To evaluate if the aspirin use reduces the time of mechanical ventilation, that ranges between 0 and 28 days.

  2. Vasopressor free days [ Time Frame: 28 days ]
    To evaluate if the aspirin use reduces the days using vasoressors, that ranges between 0 and 28 days.

  3. Intensive Care Unit (ICU) free days [ Time Frame: 28 days ]
    Length of stay in the ICU, that ranges between 0 and 28 days

  4. Hospital free days [ Time Frame: 28 days ]
    Length of stay in the hospital, that ranges between 0 and 28 days

  5. Renal replacement therapy [ Time Frame: 28 days ]
    Length of stay in renal replacement therapy, that ranges between 0 and 28 days



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Eligibility - patients:

Inclusion criteria:

The three criteria below must be present:

  1. Signature of informed consent
  2. Patients must be older than 18 years old
  3. Diagnosis of sepsis and/or septic shock for less than 48 hours with at least one of the following organ dysfunctions:

    • Lactate above 4mmol/L (36mg/dL)
    • Thrombocytopenia < 100,000/mm3 or reduction > 50% in the count in the last 3 days
    • PaO2/FiO2 < 200 without signs of apparent volume overload
    • Hypotension MAP < 65mmHg refractory to volume replacement with the need to use vasopressor
    • Acute renal injury increased by 2.0 to 2.9 times from baseline or diuresis rate less than 0.5ml/kg/h for more than 12 hours

Exclusion Criteria:

  1. Pregnancy
  2. Impossibility to use the intestinal tract
  3. Death perspective in less than 24 hours
  4. Patients in the end of their lives or in exclusive palliative care
  5. Patients with active bleeding
  6. Prior study participation
  7. Known allergy to aspirin
  8. Active peptic ulcer
  9. Previous use of antiplatelet agents in the last 7 days
  10. Previous use of AINEs in the last 7 days, except for dipyrone.
  11. Patients at high risk of bleeding, defined by the presence of at least one of the criteria below:

    • Hemorrhagic stroke in the last 7 days or central nervous system surgery in the last 72 hours.
    • Platelets <30,000 cells/mm3
    • Large surgery in the last 24 hours if the attending surgeon judges that the risk of bleeding is high enough that aspirin cannot be used
    • Ophthalmologic surgery postoperative and transurethral resection of the prostate at the discretion of the attending physician
    • Hepatic cirrhosis or previous liver disease with altered prothrombin activity, manifested by INR above 2.0 or other previous coagulopathies
    • Severe head injury in the last 7 days
    • Presence of epidural catheter The treatments to be compared in the study are a dose of 200 mg of aspirin daily for 7 days and a placebo. Both look identical.

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): NCT01784159


Contacts
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Contact: Thiago ML Almeida +551155764650 thiago_ufam@hotmail.com

Locations
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Brazil
Hospital São Paulo Recruiting
São Paulo, Brazil, 04024002
Contact: Thiago ML Almeida    +551155764650    thiago_ufam@hotmail.com   
Sponsors and Collaborators
Federal University of São Paulo
Investigators
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Study Chair: Flavia Machado Federal University of São Paulo

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Responsible Party: Flavia Ribeiro Machado, Professor of Intensive Care Medicine, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01784159     History of Changes
Other Study ID Numbers: EPM81449
First Posted: February 5, 2013    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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 Flavia Ribeiro Machado, Federal University of São Paulo:
ICU
Sepsis
Aspirin
Septic shock
Additional relevant MeSH terms:
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Sepsis
Toxemia
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics