SepsisPhase 4NCT02647554
Ulinastatin Treatment in Adult Patients With Sepsis and Septic Shock in China
A Phase 4 study testing ulinastatin in people with Sepsis and Septic Shock, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
A Prospective, Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Trial of Ulinastatin Treatment in Adult Patients with Sepsis and Septic Shock in China Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sepsis, Septic Shock
- What is being tested?
- ulinastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 347 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to 1 Aug 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
A Prospective, Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Trial of Ulinastatin Treatment in Adult Patients with Sepsis and Septic Shock in China
Read the detailed description
Investigational drug：Ulinastain for Injection
Study title： A Prospective, Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Trial of Ulinastatin Treatment in Adult Patients with Sepsis and Septic Shock in China
Principal Investigator：Professor Bin Du, Medical Intensive Care Unit, Peking Union Medical College Hospital; Professor Xiangyou Yu, Critical Care Medicine, First Affiliated Hospital, Xinjiang Medical University
Study subjects： Adult patients with sepsis and septic shock will be eligible for inclusion if all of the inclusion criteria are met within 48 hours of meeting criteria of sepsis-3 definition
Study phase： Investigator Initiated Trial(IIT)
Study objectives： The primary objective of the study is to determine whether ulinastatin, compared to placebo, reduces 28-day all-cause mortality in patients with sepsis and septic shock
Study design： Prospective, Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Clinical Trial
Medication method：
- Ulinastain treatment group： 400,000 IU ulinastatin or matching placebo 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. Intravenous infusion, The study drug will be infused intravenously over 1 hour.
- Placebo control group：Matching with medication
Course：10 days
Sample size： 348(174 patients of treatment group, 174 patients of control group)
Sites： 15
Primary endpoint：The primary outcome measure for the study is death from all causes at 28-days.
Secondary endpoints:
- Mortality rate at 90-days
- Mortality rate in ICU
- Mortality rate at hospital discharge
- ICU-free days in 28 days
- Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score at 1, 3, 6, 10,14, and 28 days after randomization
- Incidence and duration of supportive care for organ dysfunction including vasoactive agents, invasive or noninvasive mechanical ventilation, continuous renal replacement therapy(CRRT)
- Blood lactate concentration at 1, 3, 6 and 10 days after randomization
- Condition of fluid balance within 10 days after randomization
- High-sensitivity C-reactive protein (hs-CRP), IL-6, IL-10, TNF-α at 1, 3,6 and 10 days after randomization
- ADL level at hospital discharge
Safety endpoints
- adverse events
- serious adverse events
- vital signs, complete blood counts, chemistry, electrocardiograms
- Conditions
- Sepsis, Septic Shock
- Being tested
- ulinastatin, Placebo
- Keywords
- sepsis, septic shock, Ulinastatin, adult, China
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ulinastatinDrug
Also called urinary trypsin inhibitor
ulinastatin 400,000 IU every 8 hours for 10 days
PlaceboDrug
matching placebo every 8 hours for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Ulinastatin group | Experimental | 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. Receives: Drug: ulinastatin |
| Placebo group | Placebo comparator | Placebo control group：Matching with medication Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
death from all causes at 28-days
Measured: 28 days
Secondary outcomes (22)
mortality
mortality rate at 90 days
Measured: 90 days
mortality in ICU
mortality rate at ICU discharge
Measured: through ICU discharge, an average of 14 days
mortality rate at hospital discharge
mortality rate at hospital discharge
Measured: through hospital discharge, an average of 21 days
ICU-free days
The time not indwelling in ICU in 28 days
Measured: 28 days
SOFA score
Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score at 1, 3, 6, 10,14, and 28 days after randomization
Measured: Day 1,3,6,10,14,28 after randomization
incidence of supportive care
Incidence of supportive care for organ dysfunction including vasoactive agents, invasive or noninvasive mechanical ventilation, continuous renal replacement therapy(CRRT)
Measured: through ICU discharge, an average of 14 days
duration of supportive care
Duration of supportive care for organ dysfunction including vasoactive agents, invasive or noninvasive mechanical ventilation, continuous renal replacement therapy(CRRT)
Measured: through ICU discharge, an average of 14 days
blood lactate concentration
Blood lactate concentration at 1, 3, 6 and 10 days after randomization
Measured: Day 1,3,6,10 after randomization
fluid balance
Condition of fluid balance in ICU after randomization
Measured: through ICU discharge, an average of 10 days
serum hsCRP
High-sensitivity C-reactive protein (hs-CRP) at 1, 3,6 and 10 days after randomization
Measured: Day 1,3,6,10 after randomization
serum IL-6
IL-6 at 1, 3,6 and 10 days after randomization
Measured: Day 1,3,6,10 after randomization
serum IL-10
IL-10 at 1, 3,6 and 10 days after randomization
Measured: Day 1,3,6,10 after randomization
serum TNF-α
TNF-α at 1, 3,6 and 10 days after randomization
Measured: Day 1,3,6,10 after randomization
complete blood counts
Complete blood counts at 1-10, 14, 28 days after randomization
Measured: Day 1-10, 14, 28 after randomization
liver function (alanine aminotransferase, ALT)
Hepatic (ALT) function tests at 1-10,14 and 28 days after randomization
Measured: Day 1-10, 14, 28 after randomization
liver function (Aspartate transaminase, AST)
Hepatic (AST) function tests at 1-10,14 and 28 days after randomization
Measured: Day 1-10, 14, 28 after randomization
liver function (bilirubin)
Hepatic (bilirubin) function tests at 1-10,14 and 28 days after randomization
Measured: Day 1-10, 14, 28 after randomization
respiratory function
respiratory(PaO2/FiO2) function tests at 1-10,14 and 28 days after randomization
Measured: Day 1-10, 14, 28 after randomization
renal function
renal (creatinine) function tests at 1-10,14 and 28 days after randomization
Measured: Day 1-10, 14, 28 after randomization
Activities of daily living (ADL) at hospital discharge
Activities of daily living (ADL) level at hospital discharge. This scale is used to assess the patient's ability to run a daily living
Measured: through hospital discharge, an average of 21 days
adverse events
incidence, duration and severity of adverse events
Measured: till 28 days after randomization
serious adverse events
incidence, duration and severity of serious adverse events
Measured: till 28 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startDec 2016
- Primary completion1 May 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Techpool Bio-Pharma Co., Ltd.
- Responsible party
- Principal investigator, Bin Du, Peking Union Medical College Hospital
- Investigators
- Bin Du, MD, Principal investigator, Peking Union Medical College Hospital, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647554
- Sponsor's protocol ID
- UTI-S001
- Status last verified
- Oct 2022
- First submitted
- 27 Dec 2015
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Chalfin DB, Holbein ME, Fein AM, Carlon GC. Cost-effectiveness of monoclonal antibodies to gram-negative endotoxin in the treatment of gram-negative sepsis in ICU patients. JAMA. 1993 Jan 13;269(2):249-54.
PubMed 8417245Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.
PubMed 11445675Finfer S, Bellomo R, Lipman J, French C, Dobb G, Myburgh J. Adult-population incidence of severe sepsis in Australian and New Zealand intensive care units. Intensive Care Med. 2004 Apr;30(4):589-96. doi: 10.1007/s00134-004-2157-0. Epub 2004 Feb 12.
PubMed 14963646Padkin A, Goldfrad C, Brady AR, Young D, Black N, Rowan K. Epidemiology of severe sepsis occurring in the first 24 hrs in intensive care units in England, Wales, and Northern Ireland. Crit Care Med. 2003 Sep;31(9):2332-8. doi: 10.1097/01.CCM.0000085141.75513.2B.
PubMed 14501964Brun-Buisson C, Meshaka P, Pinton P, Vallet B; EPISEPSIS Study Group. EPISEPSIS: a reappraisal of the epidemiology and outcome of severe sepsis in French intensive care units. Intensive Care Med. 2004 Apr;30(4):580-8. doi: 10.1007/s00134-003-2121-4. Epub 2004 Mar 2.
PubMed 14997295Cheng B, Xie G, Yao S, Wu X, Guo Q, Gu M, Fang Q, Xu Q, Wang D, Jin Y, Yuan S, Wang J, Du Z, Sun Y, Fang X. Epidemiology of severe sepsis in critically ill surgical patients in ten university hospitals in China. Crit Care Med. 2007 Nov;35(11):2538-46. doi: 10.1097/01.CCM.0000284492.30800.00.
PubMed 17828034Angus DC, van der Poll T. Severe sepsis and septic shock. N Engl J Med. 2013 Nov 21;369(21):2063. doi: 10.1056/NEJMc1312359. No abstract available.
PubMed 24256390Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb S, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including The Pediatric Subgroup. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock, 2012. Intensive Care Med. 2013 Feb;39(2):165-228. doi: 10.1007/s00134-012-2769-8. Epub 2013 Jan 30.
PubMed 23361625Christaki E, Anyfanti P, Opal SM. Immunomodulatory therapy for sepsis: an update. Expert Rev Anti Infect Ther. 2011 Nov;9(11):1013-33. doi: 10.1586/eri.11.122.
PubMed 22029521Sharony R, Yu PJ, Park J, Galloway AC, Mignatti P, Pintucci G. Protein targets of inflammatory serine proteases and cardiovascular disease. J Inflamm (Lond). 2010 Aug 30;7:45. doi: 10.1186/1476-9255-7-45.
PubMed 20804552Inoue K, Takano H, Yanagisawa R, Yoshikawa T. Protective effects of urinary trypsin inhibitor on systemic inflammatory response induced by lipopolysaccharide. J Clin Biochem Nutr. 2008 Nov;43(3):139-42. doi: 10.3164/jcbn.2008059. Epub 2008 Oct 31.
PubMed 19015747Huang N, Wang F, Wang Y, Hou J, Li J, Deng X. Ulinastatin improves survival of septic mice by suppressing inflammatory response and lymphocyte apoptosis. J Surg Res. 2013 Jun 15;182(2):296-302. doi: 10.1016/j.jss.2012.10.043. Epub 2012 Nov 9.
PubMed 23158408Shao YM, Zhang LQ, Deng LH, Yao HG. [Clinical study on effects of ulinastatin on patients with systemic inflammatory response syndrome]. Zhongguo Wei Zhong Bing Ji Jiu Yi Xue. 2005 Apr;17(4):228-30. Chinese.
PubMed 15836828Karnad DR, Bhadade R, Verma PK, Moulick ND, Daga MK, Chafekar ND, Iyer S. Intravenous administration of ulinastatin (human urinary trypsin inhibitor) in severe sepsis: a multicenter randomized controlled study. Intensive Care Med. 2014 Jun;40(6):830-8. doi: 10.1007/s00134-014-3278-8. Epub 2014 Apr 16.
PubMed 24737258Yuhara H, Ogawa M, Kawaguchi Y, Igarashi M, Shimosegawa T, Mine T. Pharmacologic prophylaxis of post-endoscopic retrograde cholangiopancreatography pancreatitis: protease inhibitors and NSAIDs in a meta-analysis. J Gastroenterol. 2014 Mar;49(3):388-99. doi: 10.1007/s00535-013-0834-x. Epub 2013 May 30.
PubMed 23720090
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02647554
- Acronym / sponsor ID
- UTI-S001
- Conditions
- Sepsis, Septic Shock
- Keywords
- sepsis, septic shock, Ulinastatin, adult, China
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Techpool Bio-Pharma Co., Ltd.
- Study start
- Dec 2016
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Prospective, Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Trial of Ulinastatin Treatment in Adult Patients with Sepsis and Septic Shock in China
Detailed description
Investigational drug：Ulinastain for Injection
Study title： A Prospective, Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Trial of Ulinastatin Treatment in Adult Patients with Sepsis and Septic Shock in China
Principal Investigator：Professor Bin Du, Medical Intensive Care Unit, Peking Union Medical College Hospital; Professor Xiangyou Yu, Critical Care Medicine, First Affiliated Hospital, Xinjiang Medical University
Study subjects： Adult patients with sepsis and septic shock will be eligible for inclusion if all of the inclusion criteria are met within 48 hours of meeting criteria of sepsis-3 definition
Study phase： Investigator Initiated Trial(IIT)
Study objectives： The primary objective of the study is to determine whether ulinastatin, compared to placebo, reduces 28-day all-cause mortality in patients with sepsis and septic shock
Study design： Prospective, Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Clinical Trial
Medication method：
- Ulinastain treatment group： 400,000 IU ulinastatin or matching placebo 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. Intravenous infusion, The study drug will be infused intravenously over 1 hour.
- Placebo control group：Matching with medication
Course：10 days
Sample size： 348(174 patients of treatment group, 174 patients of control group)
Sites： 15
Primary endpoint：The primary outcome measure for the study is death from all causes at 28-days.
Secondary endpoints:
- Mortality rate at 90-days
- Mortality rate in ICU
- Mortality rate at hospital discharge
- ICU-free days in 28 days
- Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score at 1, 3, 6, 10,14, and 28 days after randomization
- Incidence and duration of supportive care for organ dysfunction including vasoactive agents, invasive or noninvasive mechanical ventilation, continuous renal replacement therapy(CRRT)
- Blood lactate concentration at 1, 3, 6 and 10 days after randomization
- Condition of fluid balance within 10 days after randomization
- High-sensitivity C-reactive protein (hs-CRP), IL-6, IL-10, TNF-α at 1, 3,6 and 10 days after randomization
- ADL level at hospital discharge
Safety endpoints
- adverse events
- serious adverse events
- vital signs, complete blood counts, chemistry, electrocardiograms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ulinastatin group | Experimental | Drug: ulinastatinUlinastain 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. |
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo control group：Matching with medication |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ulinastatinAlso: urinary trypsin inhibitorulinastatin 400,000 IU every 8 hours for 10 days | Drug | Ulinastatin group |
| Placebomatching placebo every 8 hours for 10 days | Drug | Placebo group |
Primary outcome
all cause mortality
Time frame: 28 days
death from all causes at 28-days
22 secondary outcomes
mortality
Time frame: 90 days
mortality in ICU
Time frame: through ICU discharge, an average of 14 days
mortality rate at hospital discharge
Time frame: through hospital discharge, an average of 21 days
ICU-free days
Time frame: 28 days
SOFA score
Time frame: Day 1,3,6,10,14,28 after randomization
incidence of supportive care
Time frame: through ICU discharge, an average of 14 days
duration of supportive care
Time frame: through ICU discharge, an average of 14 days
blood lactate concentration
Time frame: Day 1,3,6,10 after randomization
fluid balance
Time frame: through ICU discharge, an average of 10 days
serum hsCRP
Time frame: Day 1,3,6,10 after randomization
serum IL-6
Time frame: Day 1,3,6,10 after randomization
serum IL-10
Time frame: Day 1,3,6,10 after randomization
serum TNF-α
Time frame: Day 1,3,6,10 after randomization
complete blood counts
Time frame: Day 1-10, 14, 28 after randomization
liver function (alanine aminotransferase, ALT)
Time frame: Day 1-10, 14, 28 after randomization
liver function (Aspartate transaminase, AST)
Time frame: Day 1-10, 14, 28 after randomization
liver function (bilirubin)
Time frame: Day 1-10, 14, 28 after randomization
respiratory function
Time frame: Day 1-10, 14, 28 after randomization
renal function
Time frame: Day 1-10, 14, 28 after randomization
Activities of daily living (ADL) at hospital discharge
Time frame: through hospital discharge, an average of 21 days
adverse events
Time frame: till 28 days after randomization
serious adverse events
Time frame: till 28 days after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Background: PubMed 8417245Chalfin DB, Holbein ME, Fein AM, Carlon GC. Cost-effectiveness of monoclonal antibodies to gram-negative endotoxin in the treatment of gram-negative sepsis in ICU patients. JAMA. 1993 Jan 13;269(2):249-54.
- Background: PubMed 11445675Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.
- Background: PubMed 14963646Finfer S, Bellomo R, Lipman J, French C, Dobb G, Myburgh J. Adult-population incidence of severe sepsis in Australian and New Zealand intensive care units. Intensive Care Med. 2004 Apr;30(4):589-96. doi: 10.1007/s00134-004-2157-0. Epub 2004 Feb 12.
- Background: PubMed 14501964Padkin A, Goldfrad C, Brady AR, Young D, Black N, Rowan K. Epidemiology of severe sepsis occurring in the first 24 hrs in intensive care units in England, Wales, and Northern Ireland. Crit Care Med. 2003 Sep;31(9):2332-8. doi: 10.1097/01.CCM.0000085141.75513.2B.
- Background: PubMed 14997295Brun-Buisson C, Meshaka P, Pinton P, Vallet B; EPISEPSIS Study Group. EPISEPSIS: a reappraisal of the epidemiology and outcome of severe sepsis in French intensive care units. Intensive Care Med. 2004 Apr;30(4):580-8. doi: 10.1007/s00134-003-2121-4. Epub 2004 Mar 2.
- Background: PubMed 17828034Cheng B, Xie G, Yao S, Wu X, Guo Q, Gu M, Fang Q, Xu Q, Wang D, Jin Y, Yuan S, Wang J, Du Z, Sun Y, Fang X. Epidemiology of severe sepsis in critically ill surgical patients in ten university hospitals in China. Crit Care Med. 2007 Nov;35(11):2538-46. doi: 10.1097/01.CCM.0000284492.30800.00.
- Background: PubMed 24256390Angus DC, van der Poll T. Severe sepsis and septic shock. N Engl J Med. 2013 Nov 21;369(21):2063. doi: 10.1056/NEJMc1312359. No abstract available.
- Background: PubMed 23361625Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb S, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including The Pediatric Subgroup. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock, 2012. Intensive Care Med. 2013 Feb;39(2):165-228. doi: 10.1007/s00134-012-2769-8. Epub 2013 Jan 30.
- Background: PubMed 22029521Christaki E, Anyfanti P, Opal SM. Immunomodulatory therapy for sepsis: an update. Expert Rev Anti Infect Ther. 2011 Nov;9(11):1013-33. doi: 10.1586/eri.11.122.
- Background: PubMed 20804552Sharony R, Yu PJ, Park J, Galloway AC, Mignatti P, Pintucci G. Protein targets of inflammatory serine proteases and cardiovascular disease. J Inflamm (Lond). 2010 Aug 30;7:45. doi: 10.1186/1476-9255-7-45.
- Background: PubMed 19015747Inoue K, Takano H, Yanagisawa R, Yoshikawa T. Protective effects of urinary trypsin inhibitor on systemic inflammatory response induced by lipopolysaccharide. J Clin Biochem Nutr. 2008 Nov;43(3):139-42. doi: 10.3164/jcbn.2008059. Epub 2008 Oct 31.
- Background: PubMed 23158408Huang N, Wang F, Wang Y, Hou J, Li J, Deng X. Ulinastatin improves survival of septic mice by suppressing inflammatory response and lymphocyte apoptosis. J Surg Res. 2013 Jun 15;182(2):296-302. doi: 10.1016/j.jss.2012.10.043. Epub 2012 Nov 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bin Du, MD principal investigator
Peking Union Medical College Hospital, Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ulinastatin in people with Sepsis and Septic Shock, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02647554, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022; AzTrials last refreshed its copy on 8 Nov 2026.