Clinical trial NCT04990752: Effects of Ulinastatin on Inflammatory Response During ECMO Support
Official title: Effects of Ulinastatin on Persistent Inflammatory Response During ECMO Support
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ECMO
Inflammatory Response
Keywords: ulinastatin
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Shenzhen Hospital of Southern Medical University
name: Huadu District People's Hospital of Guangzhou
name: Foshan Hospital of Traditional Chinese Medicine
name: Dongguan People's Hospital
First posted: 2021-08-04
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with indications for receiving ECMO support and who, at the clinician's discretion, need ECMO support.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: CRP level
timeFrame: change from admission to 5 days after ECMO support
measure: IL-6 level, IL-10 level
timeFrame: change from admission to 5 days after ECMO support
measure: TNF-α level
timeFrame: change from admission to 5 days after ECMO support
Secondary outcomes:
measure: Capillary leakage index
timeFrame: change from admission to 5 days after ECMO support
measure: Renal function
timeFrame: change from admission to 5 days after ECMO support
measure: Liver function
timeFrame: change from admission to 5 days after ECMO support
measure: Myocardial injury indexes
timeFrame: change from admission to 5 days after ECMO support
measure: Cardiac function
timeFrame: change from admission to 5 days after ECMO support
measure: Infection
timeFrame: change from admission to 5 days after ECMO support
measure: Immunity
timeFrame: change from admission to 5 days after ECMO support
measure: Incidence of new organ insufficiency/failure during ECMO support
timeFrame: during ECMO support
measure: Duration of use of ECMO/length of hospital stay/length of ICU stay
timeFrame: through study completion
measure: Mortality rate of in-hospital /28d/90d
timeFrame: 90 days after admission
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nangfang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hosptial of Southern Medical University
name: Zhongqing Chen, doctor
role: STUDY_CHAIR
References: