Effects of Ulinastatin on Inflammatory Response During ECMO Support (Uli-ECMO)

July 27, 2021 updated by: Nanfang Hospital of Southern Medical University

Effects of Ulinastatin on Persistent Inflammatory Response During ECMO Support

This study is a multicenter, prospective, observational cohort study. The subjects were patients who received ECMO support. According to whether ulinastatin is used in the treatment regimen (determined by the competent doctor according to the patient's condition), the patients were divided into the ulinastatin and control groups. In the ulinastatin group, ulinastatin was used for inflammation management and organ protection early before ECMO was started. Baseline data and inflammatory markers (CRP, IL-6, IL-10, TNF-α), capillary leakage markers, routine test results, duration of ECMO use/length of hospital stay/length of ICU stay were recorded at 1, 3, and 5 days after the start of ECMO support, and patients were followed up on the 28th and 90th days.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a multicenter, prospective, observational cohort study. The subjects were patients who received ECMO support. According to whether ulinastatin is used in the treatment regimen (determined by the competent doctor according to the patient's condition), the patients were divided into the ulinastatin and control groups. 144 subjects were enrolled, including 72 subjects in the ulinastatin group and 72 subjects in the control group. In the ulinastatin group, ulinastatin was used for inflammation management and organ protection early before ECMO was started. The recommended clinical routine dosage of ulinastatin is 300,000 IU, q8h (continuous administration for more than 5 days). Baseline data and inflammatory markers (CRP, IL-6, IL-10, TNF-α), capillary leakage markers, routine test results, duration of ECMO use/length of hospital stay/length of ICU stay were recorded at 1, 3, and 5 days after the start of ECMO support, and patients were followed up on the 28th and 90th days.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nangfang Hospital of Southern Medical University
        • Contact:
          • Wenyuan Li, Dr
          • Phone Number: 020-61641888

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with indications for receiving ECMO support and who, at the clinician's discretion, need ECMO support.

Description

Inclusion Criteria:

  • Voluntarily signed informed consent;
  • ≥18 years old;
  • Patients have indications for ECMO support;

Exclusion Criteria:

  • Pregnancy or lactation;
  • Withdrawal of ECMO or death of the patient within 48 hours of the start of operation;
  • Solid-organ or bone marrow transplant recipients;
  • Previous history of allergy to ulinastatin or any ingredient or preservative;
  • Patients with autoimmune diseases, tumors, or patients receiving high doses of glucocorticoids or immunosuppressant therapy within 2 months;
  • Patients judged by the investigator to be unsuitable for participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
The ulinastatin group
In the ulinastatin group, ulinastatin was used for inflammation management and organ protection early before ECMO was started. The recommended dosage of ulinastatin is 300,000 IU, q8h (Continuous administration for more than 5 days).
Drug: ulinastatin
In the ulinastatin group, early application of ulinastatin was performed for inflammation management and organ protection before ECMO initiation.The recommended clinical routine dosage of ulinastatin is 300,000 IU, q8h (continuous administration for more than 5 days).
The control group
In the control group, patients were treated with conventional treatment without ulinastatin.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CRP level
Time Frame: change from admission to 5 days after ECMO support
The serum levels of CRP
change from admission to 5 days after ECMO support
IL-6 level, IL-10 level
Time Frame: change from admission to 5 days after ECMO support
The serum levels of IL-6 and IL-10
change from admission to 5 days after ECMO support
TNF-α level
Time Frame: change from admission to 5 days after ECMO support
The serum levels of TNF-α
change from admission to 5 days after ECMO support

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Capillary leakage index
Time Frame: change from admission to 5 days after ECMO support
CRP(mg/dl)/ALB(g/L)
change from admission to 5 days after ECMO support
Renal function
Time Frame: change from admission to 5 days after ECMO support
The serum levels of creatinine
change from admission to 5 days after ECMO support
Liver function
Time Frame: change from admission to 5 days after ECMO support
The serum levels of ALTand AST
change from admission to 5 days after ECMO support
Myocardial injury indexes
Time Frame: change from admission to 5 days after ECMO support
The serum levels of cTnT and CK-MB
change from admission to 5 days after ECMO support
Cardiac function
Time Frame: change from admission to 5 days after ECMO support
The serum levels of NT-Pro-BNP
change from admission to 5 days after ECMO support
Infection
Time Frame: change from admission to 5 days after ECMO support
The serum levels of PCT
change from admission to 5 days after ECMO support
Immunity
Time Frame: change from admission to 5 days after ECMO support
The serum levels of LYM and WBC
change from admission to 5 days after ECMO support
Incidence of new organ insufficiency/failure during ECMO support
Time Frame: during ECMO support
Incidence of new organ insufficiency/failure during ECMO support
during ECMO support
Duration of use of ECMO/length of hospital stay/length of ICU stay
Time Frame: through study completion
Duration of use of ECMO/length of hospital stay/length of ICU stay
through study completion
Mortality rate of in-hospital /28d/90d
Time Frame: 90 days after admission
Mortality rate of in-hospital /28d/90d
90 days after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanfang Hospital of Southern Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dongguan People's Hospital
Foshan Hospital of Traditional Chinese Medicine
Shenzhen Hospital of Southern Medical University
Huadu District People's Hospital of Guangzhou

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Zhongqing Chen, doctor, Nanfang Hosptial of Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 26, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NFEC-2021-154

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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