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Ulinastatin Treatment in Adult Patients With Sepsis and Septic Shock in China

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02647554
Recruitment Status : Recruiting
First Posted : January 6, 2016
Last Update Posted : August 29, 2019
Sponsor:
Collaborator:
Techpool Bio-Pharma Co., Ltd.
Information provided by (Responsible Party):
Bin Du, Peking Union Medical College Hospital

Brief Summary:
A Prospective, Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Trial of Ulinastatin Treatment in Adult Patients with Sepsis and Septic Shock in China

Condition or disease Intervention/treatment Phase
Sepsis Septic Shock Drug: ulinastatin Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 384 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Trial of Ulinastatin Treatment in Adult Patients With Sepsis and Septic Shock in China
Study Start Date : December 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Ulinastatin group
Ulinastain treatment group:400,000 IU ulinastatin will be reconstituted in 10 mL of 0.9% normal saline, and then dissolved in 100 mL of 0.9% normal saline every 8 hours for 10 days in a double-blind fashion.
Drug: ulinastatin
ulinastatin 400,000 IU every 8 hours for 10 days
Other Name: urinary trypsin inhibitor

Placebo Comparator: Placebo group
Placebo control group:Matching with medication
Drug: Placebo
matching placebo every 8 hours for 10 days




Primary Outcome Measures :
  1. all cause mortality [ Time Frame: 28 days ]
    death from all causes at 28-days


Secondary Outcome Measures :
  1. mortality [ Time Frame: 90 days ]
    mortality rate at 90 days

  2. mortality in ICU [ Time Frame: through ICU discharge, an average of 14 days ]
    mortality rate at ICU discharge

  3. mortality rate at hospital discharge [ Time Frame: through hospital discharge, an average of 21 days ]
    mortality rate at hospital discharge

  4. ICU-free days [ Time Frame: 28 days ]
    The time not indwelling in ICU in 28 days

  5. SOFA score [ Time Frame: Day 1,3,6,10,14,28 after randomization ]
    Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score at 1, 3, 6, 10,14, and 28 days after randomization

  6. incidence of supportive care [ Time Frame: through ICU discharge, an average of 14 days ]
    Incidence of supportive care for organ dysfunction including vasoactive agents, invasive or noninvasive mechanical ventilation, continuous renal replacement therapy(CRRT)

  7. duration of supportive care [ Time Frame: through ICU discharge, an average of 14 days ]
    Duration of supportive care for organ dysfunction including vasoactive agents, invasive or noninvasive mechanical ventilation, continuous renal replacement therapy(CRRT)

  8. blood lactate concentration [ Time Frame: Day 1,3,6,10 after randomization ]
    Blood lactate concentration at 1, 3, 6 and 10 days after randomization

  9. fluid balance [ Time Frame: through ICU discharge, an average of 10 days ]
    Condition of fluid balance in ICU after randomization

  10. serum hsCRP [ Time Frame: Day 1,3,6,10 after randomization ]
    High-sensitivity C-reactive protein (hs-CRP) at 1, 3,6 and 10 days after randomization

  11. serum IL-6 [ Time Frame: Day 1,3,6,10 after randomization ]
    IL-6 at 1, 3,6 and 10 days after randomization

  12. serum IL-10 [ Time Frame: Day 1,3,6,10 after randomization ]
    IL-10 at 1, 3,6 and 10 days after randomization

  13. serum TNF-α [ Time Frame: Day 1,3,6,10 after randomization ]
    TNF-α at 1, 3,6 and 10 days after randomization

  14. complete blood counts [ Time Frame: Day 1-10, 14, 28 after randomization ]
    Complete blood counts at 1-10, 14, 28 days after randomization

  15. liver function (alanine aminotransferase, ALT) [ Time Frame: Day 1-10, 14, 28 after randomization ]
    Hepatic (ALT) function tests at 1-10,14 and 28 days after randomization

  16. liver function (Aspartate transaminase, AST) [ Time Frame: Day 1-10, 14, 28 after randomization ]
    Hepatic (AST) function tests at 1-10,14 and 28 days after randomization

  17. liver function (bilirubin) [ Time Frame: Day 1-10, 14, 28 after randomization ]
    Hepatic (bilirubin) function tests at 1-10,14 and 28 days after randomization

  18. respiratory function [ Time Frame: Day 1-10, 14, 28 after randomization ]
    respiratory(PaO2/FiO2) function tests at 1-10,14 and 28 days after randomization

  19. renal function [ Time Frame: Day 1-10, 14, 28 after randomization ]
    renal (creatinine) function tests at 1-10,14 and 28 days after randomization

  20. Activities of daily living (ADL) at hospital discharge [ Time Frame: through hospital discharge, an average of 21 days ]
    Activities of daily living (ADL) level at hospital discharge. This scale is used to assess the patient's ability to run a daily living

  21. adverse events [ Time Frame: till 28 days after randomization ]
    incidence, duration and severity of adverse events

  22. serious adverse events [ Time Frame: till 28 days after randomization ]
    incidence, duration and severity of serious adverse events



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

Inclusion Criteria:Patients will be eligible for inclusion if all of the inclusion criteria are met

1) Sepsis-3 criteria from Society of Critical Care Medicine (SCCM) /European Society of Intensive Care Medicine(ESICM)

  1. Suspected or confirmed infection AND
  2. Evidence of acute organ dysfunction • in patients not known to have preexisting organ dysfunction (The baseline SOFA score can be assumed to be zero): total SOFA score ≥2 points from 48 hours before infection to 24 hours after infection.

    • in patients known to have preexisting organ dysfunction (The baseline SOFA score can be assumed according to baseline conditions): changes of total SOFA score ≥2 points from 48 hours before infection to 24 hours after infection.

    2)48 hours within diagnosis of sepsis 3)Signed and dated informed consent should be obtained prior to any screening procedures from subjects (or legal representatives). If the subject is unable to provide consent, it could be obtained from legal representatives according to local regulation. Consent from subject should be obtained afterwards when available.

    4) Fertile men or women should agree to use efficient birth control methods during the treatment period and at least 28 days after last dose. Fertile is defined as biologically fertile and sexually active from investigator's view.

    5) Non-childbearing women (meet at least one of following criteria):

    • Past hysterectomy or bilateral oothectomy;

    • Medically confirmed ovarian failure, or menopause (amenorrhea for 12 month or more and with no other pathological or physiological reason)

    Exclusion Criteria:

    1) Age < 18 years, or age>80 years 2) Pregnancy or lactating 3) New York Heart Association Class IV congestive heart failure, nonseptic cardiogenic shock, or uncontrolled acute blood loss 4) Severe, preexisting, parenchymal liver disease with clinically significant portal hypertension, Child-Pugh C stage cirrhosis or acute liver failure 5) Receipt of a solid-organ or bone marrow transplant 6) Advanced pulmonary fibrosis or non invasive ventilation before study entry 7) Myocardial infarction within the previous 3 months 8) Cardiopulmonary resuscitation within 72 hours before study entry 9) Invasive fungal infection or active pulmonary tuberculosis 10) Full-thickness thermal or chemical burn involving 30% or more of body surface area 11) Evidence of significant drug- or disease-induced immunosuppression

    · Evidence of moderate or severe neutropenia, i.e. absolute neutrophil count (ANC) < 1.0 x 10^9/L

    • Administration of high doses of corticosteroids, i.e. doses of > 20 mg/day of prednisone or equivalent, for ≥ 2 weeks immediately prior to evaluation for enrollment. Hydrocortisone at dose ≤ 300 mg/d for treatment of septic shock is acceptable.
    • Immunomodulatory medication (e.g. cyclosporine, azathioprine, OKT3), chemotherapy, or radiation therapy within 2 months before study entry
    • Known HIV seropositivity
    • Any disease sufficiently advanced to suppress resistance to infection
    • Non-remission stage of hematological/lymphoid tumor 12) Previous Xuebijing, thymosin or IVIG Within 2 months before study entry 12) Inability to obtain informed consent or assent 13) Participation in an investigational clinical trial within 6 months of screening 14) Expected survival < 2 months or chronic vegetative state 15) Lack of commitment to full, aggressive, life support 16) History of hypersensitivity to ulinastatin or any excipients or preservatives

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): NCT02647554


Contacts
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Contact: Bin Du, MD 0086-10-69155036 dubin98@gmail.com
Contact: Wei Jiang, MD 0086-10-69154035 edwardjw@163.com

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China
Contact: Bin Du, MD    0086-10-69155036    dubin98@gmail.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Techpool Bio-Pharma Co., Ltd.
Investigators
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Principal Investigator: Bin Du, MD Peking Union Medical College Hospital, Beijing, China

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bin Du, Director of Medical ICU, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02647554    
Other Study ID Numbers: UTI-S001
First Posted: January 6, 2016    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Bin Du, Peking Union Medical College Hospital:
sepsis
septic shock
Ulinastatin
adult
China
Additional relevant MeSH terms:
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Sepsis
Toxemia
Shock, Septic
Shock
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Urinastatin
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action