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Effects of ulinastatin on microcirculation in patients with acute circulatory failure due to infection - a prospective, open label, randomised controlled trial

Effects of ulinastatin on microcirculation in patients with acute circulatory failure due to infection - a prospective, open label, randomised controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17011763
Enrollment
Unknown
Registered
2017-06-26
Start date
2017-07-08
Completion date
Unknown
Last updated
2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

shock

Interventions

1:routin therapy
2:routin therapy +ulinastatin 40wU tid×7d

Sponsors

The Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria can be included in this study: 1. infection or suspected infection 2. the clinical manifestation of low perfusion (conforming to at least one of the following) (1) consciousness changes: including irritability, indifference, delirium, and coma; (2) the amount of urine is decreased: adequate rehydration is still 2s. 3. lactic acid > 2mmol/L or hypotension (systolic blood pressure < 90mmHg, or pulse pressure < 20mmHg, or the systolic blood pressure of the original high blood pressure from a baseline decline of greater than 40mmHg); 4. aged 18 to 80 years.

Exclusion criteria

Exclusion criteria: Patients will be excluded from the study if they are subject to any of the following criteria, based on the physician's judgment. 1. patients who can't observe the blood vessels under the tongue: oral surgery, oral bleeding, etc 2. pregnant and breastfeeding women; 3. use traditional Chinese medicine for activating blood circulation to dissipate blood stasis, thoracic glands, or glucocorticoids; 4. infection control poor patient; 5. after chemotherapy, radiation therapy, organ transplantation and immunosuppressant and excessive application in two days before the onset of nonsteroidal anti-inflammatory drugs (such as 1 g/day or more Aspirin); 6. give up treating patients; 7. the estimated 48h deaths are expected; 8. abdominal pressure > 10mmHg (13.3 cmH2O); 9. there is an allergy history of ulinastatin or any ingredient or preservative; 10. unable to obtain informed consent or authorization; 11. to participate in other exploratory clinical trials within six months of screening; 12. do not agree to comprehensive, positive life support treatment.

Design outcomes

Primary

MeasureTime frame
microvascular flow index, MFI;

Secondary

MeasureTime frame
microvascular flow index, MFI;proportion of perfused small vessels, PPV;perfused small vessel density, PVD;total vessel density, TVD;Arterial lactate;?????;incidence of new organ failure;delta SOFA;all-cause mortality;fuild volume until BP return to normal;totoal dosage of noradrenaline;proportion of using vasoactive agent;The duration of hypotension;

Countries

China

Contacts

Public ContactSun Yunbo

The Affiliated Hospital of Qingdao University

sunyunbo@163.com+86 0532 82912220

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026