Prevention of Ulinastatin on Acute Respiratory Distress Syndrome (ARDS)

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

Interventions

DRUG

Ulinastatin

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.

OTHER

Usual care

Usual care in ICU.

Sponsors & Collaborators

• Chinese PLA General Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Peking University Shenzhen Hospital

  collaborator OTHER

• Central Hospital of Zi Bo

  collaborator UNKNOWN

• Beijing Anzhen Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• Beijing Shijitan Hospital Affiliated to Capital Medical University

  collaborator UNKNOWN

• Peking University Third Hospital

  lead OTHER

Principal Investigators

• Xi Zhu, M.D. · Peking University Third Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-02-20

Primary Completion

2020-12-17

Completion

2021-07-01

Countries

• China

Study Locations