Prevention of Ulinastatin on Acute Respiratory Distress Syndrome (ARDS)

NCT03089957 | Completed DMC

• 1 other identifier: 2016-0001
• Study Type: interventional
• Target: 840
• Locations: 1 country
• Sites: 10

Brief Summary

Since strategies were applied in intensive care medicine, including low tidal volume ventilation, fluid resuscitation, use of antibiotics, restrictive transfusion strategy and bundle of ventilator therapy, the incidence of Acute Respiratory Distress Syndrome (ARDS) has been decreased recent years. However, the mortality of severe ARDS is still higher to 45%. Few medications did were indicated to be effective in working on development of ARDS. Different with other disease, ARDS were difficult to prevent in its later stage like a domino effect. The medication interventions are all used after ARDS was developed, including ulinastatin. The investigators hypothesized that the key point in failure of medication therapy is the delay timing of medication intervention. If given the preventive strategy, such as ulinastatin, the incidence or the severity of ARDS might be decreased. Therefore this is a randomized controlled trial to test the hypothesis of the preventive effect of ulinastatin in ARDS. This is a multi-center, randomized, double blinded, placebo controlled study.

Conditions

Acute Respiratory Distress Syndrome; Critical Illness

Keywords

Acute Respiratory Distress Syndrome; Critical Illness; Randomized Controlled Trial; Ulinastatin

Outcome Measures

Primary Outcomes (1)

• The incidence of ARDS

  3 years

Secondary Outcomes (10)

• The numbers of ARDS patients who meet the criteria for mild, moderate, and severe using the Berlin Definition, separately.

  3 years

• The number of patients who need mechanical ventilation

  3 years

• Lengths of mechanical ventilation

  3 years

• Lengths of ICU

  3 years

• Lengths of stay

  3 years

Other Outcomes (1)

• Adverse events

  3 years

Study Arms (2)

Ulinastatin group

EXPERIMENTAL

200,000 IU ulinastatin will be dissolved in 100 mL of 0.9% normal saline by continuous intravenous infusion for 1h, 3 times per day for 5 days.

Drug: Ulinastatin; Other: Usual care

Control group

PLACEBO COMPARATOR

Control group will be in usual care without any intervention.

Other: Usual care

Interventions

Ulinastatin DRUG

200,000 IU ulinastatin will be dissolved in 100 mL of 0.9% normal saline by continuous intravenous infusion for 1h, 3 times per day for 5 days.

Ulinastatin group

Usual care OTHER

Usual care in ICU.

Control group; Ulinastatin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients should be more than 18 years old
• Patients are expected to living within 72 hours of ICU admission
• Patients' Lung Injury Prediction Score (LIPS) more than 4 and got at least 1 risk factors as below: bacteremia, sepsis or sepsis shock, pneumonia, multiple fractures, pulmonary contusion, aspiration, multiple blood transfusion, severe acute pancreatitis.

You may not qualify if:

• diagnosed as ARDS
• without written informed consent
• with HIV infection
• with other immunologic deficiency (leukaemia, immune deficiency syndrome, etc)
• with organ transplantation or bone marrow transplantation
• with chronic pulmonary disease (except for Chronic Obstructive Pulmonary Disease (COPD) or asthma)
• with angitis
• with neutropenia (except for secondary to sepsis)
• using granulocyte-macrophage colony-stimulating factor or granulocyte colony-stimulating factor
• using asprin or clopidogrel
• using glucocorticoid
• withdrawing treatment
• treated by Xuebijing, thymosin, or intravenous immunoglobulin 1 month before enrollment
• enrolled in other clinical trials 3 months before enrollment
• being pregnancy

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Chinese PLA General Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Peking University Shenzhen Hospital: collaborator
• Central Hospital of Zi Bo: collaborator
• Beijing Anzhen Hospital: collaborator
• The Second Affiliated Hospital of Dalian Medical University: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator
• Beijing Shijitan Hospital Affiliated to Capital Medical University: collaborator

Study Sites (10)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Beijing Anzhen Hospital ,Capital Medical University

Beijing, Beijing Municipality, China

Location

Beijing Shijitan Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Location

Chinese Pla General Hospital

Beijing, Beijing Municipality, China

Location

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Location

The first affiliated hospital of Guangxi Medical University

Nanning, Guangxi, China

Location

CANGZHOU People's Hospital

Cangzhou, Hebei, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

The second hospital of dalian medical university

Dalian, Liaoning, China

Location

Central Hospital of Zi Bo

Zibo, Shandong, China

Location

Related Publications (5)

• Jeong CW, Lee CS, Lee SH, Jeung HJ, Kwak SH. Urinary trypsin inhibitor attenuates liver enzyme elevation after liver resection. Korean J Anesthesiol. 2012 Aug;63(2):120-3. doi: 10.4097/kjae.2012.63.2.120. Epub 2012 Aug 14.

  PMID: 22949978 BACKGROUND

• ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.

  PMID: 22797452 BACKGROUND

• Levitt JE, Calfee CS, Goldstein BA, Vojnik R, Matthay MA. Early acute lung injury: criteria for identifying lung injury prior to the need for positive pressure ventilation*. Crit Care Med. 2013 Aug;41(8):1929-37. doi: 10.1097/CCM.0b013e31828a3d99.

  PMID: 23782966 BACKGROUND

• Wang Z, Beach D, Su L, Zhai R, Christiani DC. A genome-wide expression analysis in blood identifies pre-elafin as a biomarker in ARDS. Am J Respir Cell Mol Biol. 2008 Jun;38(6):724-32. doi: 10.1165/rcmb.2007-0354OC. Epub 2008 Jan 18.

  PMID: 18203972 BACKGROUND

• Wang Z, Tao L, Yan Y, Zhu X. Rationale and design of a prospective, multicentre, randomised, conventional treatment-controlled, parallel-group trial to evaluate the efficacy and safety of ulinastatin in preventing acute respiratory distress syndrome in high-risk patients. BMJ Open. 2019 Mar 7;9(3):e025523. doi: 10.1136/bmjopen-2018-025523.

  PMID: 30850411 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Critical Illness

Interventions

urinastatin

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xi Zhu, M.D.

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Chief physician

Study Record Dates

• First Submitted: March 12, 2017
• First Posted: March 24, 2017
• Study Start: February 20, 2017
• Primary Completion: December 17, 2020
• Study Completion: July 1, 2021
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

CN (10)