ECMOUli-ECMONCT04990752
Effects of Ulinastatin on Inflammatory Response During ECMO Support
An observational study of ECMO and Inflammatory Response, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ECMO, Inflammatory Response
- What is being tested?
- ulinastatin
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 26 Jul 2021to 1 Jun 2023
- How long will I take part?
- 90 Days
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with indications for receiving ECMO support and who, at the clinician's discretion, need ECMO support.
Who may be able to join
- Voluntarily signed informed consent;
- ≥18 years old;
- Patients have indications for ECMO support;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nangfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
Wenyuan Li, Dr, 020-61641888
About this study
Official title: 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.
Read the 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.
- Conditions
- ECMO, Inflammatory Response
- Being tested
- ulinastatin
- Keywords
- ulinastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ulinastatinDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: ulinastatin | |
| The control group | In the control group, patients were treated with conventional treatment without ulinastatin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRP level
The serum levels of CRP
Measured: change from admission to 5 days after ECMO support
IL-6 level, IL-10 level
The serum levels of IL-6 and IL-10
Measured: change from admission to 5 days after ECMO support
TNF-α level
The serum levels of TNF-α
Measured: change from admission to 5 days after ECMO support
Secondary outcomes (10)
Capillary leakage index
CRP(mg/dl)/ALB(g/L)
Measured: change from admission to 5 days after ECMO support
Renal function
The serum levels of creatinine
Measured: change from admission to 5 days after ECMO support
Liver function
The serum levels of ALTand AST
Measured: change from admission to 5 days after ECMO support
Myocardial injury indexes
The serum levels of cTnT and CK-MB
Measured: change from admission to 5 days after ECMO support
Cardiac function
The serum levels of NT-Pro-BNP
Measured: change from admission to 5 days after ECMO support
Infection
The serum levels of PCT
Measured: change from admission to 5 days after ECMO support
Immunity
The serum levels of LYM and WBC
Measured: change from admission to 5 days after ECMO support
Incidence of new organ insufficiency/failure during ECMO support
Incidence of new organ insufficiency/failure during ECMO support
Measured: during ECMO support
Duration of use of ECMO/length of hospital stay/length of ICU stay
Duration of use of ECMO/length of hospital stay/length of ICU stay
Measured: through study completion
Mortality rate of in-hospital /28d/90d
Mortality rate of in-hospital /28d/90d
Measured: 90 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start26 Jul 2021
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ECMOStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 144 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Hospital of Southern Medical University, Huadu District People's Hospital of Guangzhou, Foshan Hospital of Traditional Chinese Medicine, Dongguan People's Hospital
- Responsible party
- Sponsor
- Investigators
- Zhongqing Chen, doctor, Study chair, Nanfang Hosptial of Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990752
- Sponsor's protocol ID
- NFEC-2021-154
- Acronym
- Uli-ECMO
- Status last verified
- Jun 2021
- First submitted
- 15 Jul 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ulinastatin on Persistent Inflammatory Response During ECMO Support
- ClinicalTrials.gov ID
- NCT04990752
- Acronym / sponsor ID
- Uli-ECMO / NFEC-2021-154
- Conditions
- ECMO, Inflammatory Response
- Keywords
- ulinastatin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Shenzhen Hospital of Southern Medical University, Huadu District People's Hospital of Guangzhou, Foshan Hospital of Traditional Chinese Medicine, Dongguan People's Hospital
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 4 Aug 2021 (actual)
- 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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The ulinastatin group | – | Drug: ulinastatinIn 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). |
| The control group | – | –In the control group, patients were treated with conventional treatment without ulinastatin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with indications for receiving ECMO support and who, at the clinician's discretion, need ECMO support.
Key inclusion criteria (3 listed)
- Voluntarily signed informed consent;
- ≥18 years old;
- Patients have indications for ECMO support;
Key exclusion criteria (6 listed)
- 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;
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 |
|---|---|---|
| ulinastatinIn 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). | Drug | The ulinastatin group |
Primary outcome
CRP level
Time frame: change from admission to 5 days after ECMO support
The serum levels of CRP
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
TNF-α level
Time frame: change from admission to 5 days after ECMO support
The serum levels of TNF-α
10 secondary outcomes
Capillary leakage index
Time frame: change from admission to 5 days after ECMO support
Renal function
Time frame: change from admission to 5 days after ECMO support
Liver function
Time frame: change from admission to 5 days after ECMO support
Myocardial injury indexes
Time frame: change from admission to 5 days after ECMO support
Cardiac function
Time frame: change from admission to 5 days after ECMO support
Infection
Time frame: change from admission to 5 days after ECMO support
Immunity
Time frame: change from admission to 5 days after ECMO support
Incidence of new organ insufficiency/failure during ECMO support
Time frame: during ECMO support
Duration of use of ECMO/length of hospital stay/length of ICU stay
Time frame: through study completion
Mortality rate of in-hospital /28d/90d
Time frame: 90 days after admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Individual participant dataSharing planned: Undecided
Related trials for ECMO
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach
VA-ECMO
Not yet recruitingObservational study
Diagnosis of ECMO Cannula Infection: Prospective Comparison of Sampling Methods
ECMO Cannula Infection, Extracorporeal Membrane Oxygenation Complication
RecruitingObservational study
Effect of Transpulmonary MP on Prognosis of Patients With Severe ARDS Treated With VV-ECMO
Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation
Not yet recruitingPhase 1/2
PACE: Prostacyclin AntiCoagulation in ECMO
ECMO
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.
Zhongqing Chen, doctor study chair
Nanfang Hosptial of Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ECMO and Inflammatory Response, run by Nanfang Hospital, Southern Medical University 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Aug 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Wu, doctor (18052570742, 815897457@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRP level (time frame: change from admission to 5 days after ECMO support). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2021.